Category Archives: Allergies

Medications for allergies – an FDA Consumer Update

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bee on flowerConsumer Update from the FDA

You’re sneezing, your eyes are itchy and you feel miserable. Seasonal allergies aren’t just a nuisance, they are real diseases that can interfere with work, school or recreation, and can range from mild to severe.

May is National Asthma and Allergy Awareness Month, and many allergy treatment options are approved by the Food and Drug Administration (FDA). For the first time, these include three sublingual (under the tongue) prescription products to treat hay fever (also called “allergic rhinitis”)—with or without eye inflammation (called “conjunctivitis”)—caused by certain grass pollens and short ragweed pollen.

The new products—GrastekOralair and Ragwitek—can be taken at home, but the first dose must be taken in a health care provider’s office.

About Allergies

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Women’s Health – Week 3: Asthma

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From the NIH Office of Research on Women’s Health

tacuin womenAsthma is a chronic (long-term) lung disease that inflames and narrows the bronchioles or airways. People of all ages have asthma, but it most often starts in childhood.

Asthma causes recurring periods of wheezing (a whistling sound when you breathe),  chest tightness,  shortness of breath,  and coughing. The coughing often occurs at night or early in the morning.

Many people with asthma are allergic to airborne allergens. It is believed that allergens (mostly those found indoors),  when inhaled, cause inflammation in the airways in the lungs. Inflamed airways are more sensitive to allergens,  but also extremely sensitive to irritants and to some viral infections.

Allergens,  irritants,  and viral infections can trigger asthma attacks. During an asthma attack,  the muscles surrounding the walls of the airways in the lungs constrict and narrow the airways.

Also, the inside walls of the airways become swollen, making the airways even narrower. The constricting and swelling of the airways prevent air from flowing freely through the lungs.

In a severe asthma attack,  the airways can close so much that not enough oxygen gets to vital organs like the heart and brain. These severe attacks are considered medical emergencies.

If your asthma is not well controlled, then you may miss school, work, and other activities.

asthma_v01

A diagram of the lungs showing the difference between normal airways, or bronchioles, and asthmatic bronchioles.

Symptoms of asthma include:

  • Difficulty breathing.
  • Wheezing.
  • Coughing.
  • Tightness in the chest.

Even when you feel fine,  you still have the disease and it can flare up,  especially when you breathe in allergens or irritants from the environment. These are called triggers.

Some common asthma triggers include:

  • Allergens such as animal dander from the skin,  hair,  or feathers of animals;  dust mites (contained in house dust);  cockroaches;  pollen from trees and grass;  and mold (indoor and outdoor).
  • Airborne irritants including smoke,  strong odors or scents,  and pollution.
  • Cold air,  changes in weather,  and exercise.
  • Workplace chemicals or allergens.
Asthma and pregnancy
Pregnant women who have asthma need to control the disease to ensure their fetus gets enough oxygen. Poor asthma control raises the chance that a baby will be born early,  have a low birth weight,  and be at risk of death. Studies show that it is safer to take asthma medicines while pregnant than to risk having an asthma attack. But you need to carefully review these medicines with your health care provider.

Asthma cannot be cured. With proper treatment,  most people who have asthma can control their asthma and be active all day and sleep well at night. You can control your asthma with these key actions:

  • Work with your health care provider to make a written action plan that describes how you can manage your asthma day-to-day. Be sure to ask questions and discuss any concerns about your asthma treatment. This way,  you and your health care provider can work together on a plan that is best for you.
  • Take your medications as directed. Everyone with asthma needs a quick relief medication for symptoms. Many patients need daily long-term control medication. Most of these patients use inhaled corticosteroids,  but some may need additional medications.
  • Avoid or control allergens or irritants that make your asthma worse. Your health care provider will help you learn which triggers affect you the most and how to avoid or control them.
  • Get regular asthma checkups to monitor your asthma control and see if your treatment should stay the same or be changed. Visits at least every 6 months are recommended because asthma varies from season to season and can change over time (for example,  as a child grows older or if a woman is pregnant).
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Women’s Health – Week 2: Allergies

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tacuin womenFrom the NIH Office of Research on Women’s Health

You can develop allergies when your immune system overreacts to something in the environment,  either in the air or from another source.

These environmental substances are called allergens. Allergens that commonly cause allergic reactions can be divided into airborne and non-airborne. Examples of these include:

Airborne:

  • Pollens.
  • House dust mites.
  • Cat or dog dander and saliva.
  • Mold spores.
  • Cockroaches.

Non-Airborne:

  • Food.
  • Latex rubber.
  • Insect venom.
  • Medicines (for example,  penicillin).

Your immune system usually functions as your body’s defense against bacteria and viruses. In an allergic reaction,  your immune system mistakes the allergen for an invader and sets up a response that mimics how your body attacks a bacteria or virus.

This section focuses on airborne allergens,  which are responsible for allergen-induced symptoms in the nose (allergic rhinitis),  eyes (allergic conjunctivitis),  and lungs (asthma).

Common signs and symptoms of allergic rhinitis and conjunctivitis caused by airborne allergens
  • Sneezing,  often with congestion and a runny nose.
  • Coughing and postnasal drip.
  • Itching eyes,  nose,  and throat.
  • Watering eyes.
  • Allergic shiners (dark circles under the eyes caused by increased congestion of blood vessels).

Allergic rhinitis and conjunctivitis can probably be treated with medicines. The kind of allergy medications you use will depend on the type of symptoms you have and how bad those symptoms are.

Medications you can use to treat allergic rhinitis and conjunctivitis include:

  • Antihistamines (either pills or nasal sprays – for nasal itching and runny nose).
  • Antihistamine eye drops (for eye itching and watery eyes).
  • Nasal corticosteroids (nasal sprays – for all nose symptoms).
  • Decongestants (either pills or nasal sprays – only for nasal congestion).
  • Immunotherapy (shots of allergens under the skin – for all nose and eye symptoms).
  • Allergies can lead to other more serious health problems,  including asthma.

For more information:  www.niaid.nih.gov

 

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FDA warns of rare acetaminophen risk

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A Consumer Update from the US Food and Drug Administration

ucm363013Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin.

If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines.

Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names.

It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions.

Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen.

FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section.

On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”

Ingredient Linked to Several Conditions

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

A serious skin reaction can occur at any time, even if you’ve taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

If you’ve ever had a skin reaction when taking acetaminophen, don’t take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

Evidence of Link

Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen.

In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA’s strongest warning, used for calling attention to serious risks.

The agency continues to consider the benefits of this medication to outweigh the risks.

“FDA’s actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen,” says Hertz. “Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

August 1, 2013

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Had a bad reaction to a prescription drug? FDA wants to hear about it.

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WANTED: Consumers to Report Problems

An FDA Consumer Update

Blue and white capsules spilling out of a pill bottle

new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration’s (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

The less technical form is part of a larger effort to encourage consumers to submit quality reports.

By reporting your experience or suspicion of a product problem to MedWatch, you could help identify an unknown risk and potentially spark a variety of actions—from changes to a warning label to removal of the product from the market.

Use MedWatch to report issues with:

  • Prescription and over-the-counter drugs
  • Nutrition products, including infant formulas, dietary supplements, herbal remedies
  • Cosmetics
  • Medical devices, from contacts and breast implants to test kits and pacemakers
  • Biologics, such as human cells and tissues for transplantation and medicines made from living matter
  • Food (including beverages and ingredients added to foods)

Consumers have been welcome to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993, although the focus had always been more on encouraging reporting from health care professionals.

But as more and more consumers visit online sites to research their conditions and understand their care, opportunities for increasing their participation in MedWatch became clear. FDA asked consumer groups to help promote the website and the MedWatch reporting form to their members.

“Their initial response was that the reporting form was too technical, and they suggested a more consumer-friendly version,” said Beth Fritsch, R.Ph., MBA, deputy director of FDA’s Office of Health and Constituent Affairs.

Working with groups such as AARP, Consumers Union and the National Partnership for Women and Families, FDA created a new form and published it for public comment in the Federal Register. Those comments were also considered, further revisions were made, and the less technical form is now available at MedWatch.

To spread awareness of the reporting mechanism, FDA is using social media, including Twitter, email lists and electronic newsletters. It is also getting help in this effort from librarians, consumer organizations, patient advocacy groups, health professional organizations and schools of medicine, pharmacy and nursing.

Additionally, MedWatchLearn, a new web-based learning tool, will be used to teach students in medical, pharmacy and nursing schools to fill out MedWatch reports and encourage others to do so.

How Your Reports Could Help

Even though consumers have been less likely than health care professionals to report problems to MedWatch, their cooperation to date has already been beneficial. For example, consumer reports to MedWatch led to a nationwide recall of a particular lot of pre-filled syringes.

Consumer reports also alerted FDA to an unusual issue: Men using a testosterone gel on their upper arms and shoulders were inadvertently exposing, and harming, children. The reports led to stronger product warning labels to alert the public and urge that the gel be covered after application so it wouldn’t get on other people.

“MedWatch is one of the lines of defense against products that are contaminated or that pose risks that weren’t previously known,” said Anna Fine, Pharm.D., director of FDA’s Health Professional Liaison Program. “Greater consumer involvement will mean we have more eyes and ears available to catch problems before they escalate.”

MedWatch reports sometimes provide the first clue that an issue needs investigation and possible action. In other cases, a clinician or researcher inside or outside FDA might first suspect a link between a problem and a drug or other product, and MedWatch becomes a useful database that FDA experts can search for additional clues.

Consumers can play a particularly critical role by reporting unexpected, serious side effects from medicines given to children. Most clinical trials for children’s medicines involve a relatively small number of patients, and problems might not be detected until medicines have been used by a large number of children of different ages.

How To Report

Consumers can continue to ask their health care professional to file a MedWatch report or to report a suspected problem directly to a drug manufacturer.

By law, companies are required to report to FDA certain serious problems that may have been caused by their products, including in cases where consumers report suspected problems to the company. Currently, the vast majority of more than 900,000 MedWatch reports a year are funneled to FDA through companies.

However, consumers who decide to report a problem directly to FDA themselves will find that the new form is now easier and quicker to fill out.

“There is a delicate balance between asking for useful, scientific data and encouraging participation by making the form accessible to consumers,” said Fritsch. “We’ve made a great effort to find that balance.”

Consumers are not expected to provide proof that the problem was caused by the particular product. And Fritsch adds that consumers should send the report even if they don’t have all the information requested. Questions are answered at MedWatch’s toll-free line, 1-800-332-1088, between 8 a.m. and 4:30 p.m. ET.

MedWatch forms for both consumers and health care professionals must be faxed or mailed. Online submission capability will be available in coming months.

Fritsch, who noted that MedWatch is marking its 20th anniversary, concluded: “Every report counts.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Photo courtesy of Pawel Kryj

June 3, 2013

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How to control your seasonal allergies

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From NIH Medline Plus magazine

Trusted information from the National Institutes of Health

788px-Misc_pollen-2

Pollen

Allergic reactions occur when the body wrongly defends itself against something that is not dangerous. A healthy immune system defends against invading bacteria and viruses. During allergic reactions, however, the immune system fights harmless materials, such as pollen or mold, with production of a special class of antibody called immunoglobulin E (IgE).

Plant Pollen

Ragweed and other weeds, such as curly dock, lambs quarters, pigweed, plantain, sheep sorrel, and sagebrush are prolific producers of pollen allergens. Ragweed season runs from August to November, but pollen levels usually peak by mid-September in many areas in the country. Pollen counts are highest in the morning, and on dry, hot, windy days.

Protecting Yourself

  • Between 5:00 and 10:00 in the morning, stay indoors. Save outside activities for late afternoon or after a heavy rain, when pollen levels are lower.
  • Keep windows in your home and car closed to lower exposure to pollen. Keep cool with air conditioners. Don’t use window or attic fans.
  • Use a dryer, not a line outside; dry your clothes and avoid collecting pollen on them.

Grass Pollen

Grass pollens are regional as well as seasonal. Their levels also are affected by temperature, time of day, and rain. Only a small percentage of North America’s 1,200 grass species cause allergies, including:

  • Bermuda grass
  • Johnson grass
  • Kentucky bluegrass
  • Sweet vernal grass
  • Timothy grass
  • Orchard grass

Protecting Yourself

  • Between 5:00 and 10:00 a.m., stay indoors. Save outside activities for late afternoon or after a heavy rain, when pollen levels are lower.
  • Keep windows in your home and car closed to lower exposure to pollen. Keep cool with air conditioners. Don’t use window or attic fans.
  • Use a clothes dryer, not a line outside, to avoid collecting pollen on them.
  • Have someone else mow your lawn. If you mow, wear a mask.

Tree Pollen

Trees produce pollen earliest, as soon as January in the south, and as late as May and June in the northeast. They release huge amounts that can be distributed miles away. Fewer than 100 kinds of trees cause allergies. The most common tree allergy is against oak, but others include catalpa, elm, hickory, sycamore, and walnut.

Protecting Yourself

  • Follow the same protective strategies related to time of day, closed windows, and clothes dryers noted in “Protecting yourself” under Grass Pollen, above.
  • Plant species that do not aggravate allergies, such as crape myrtle, dogwood, fig, fir, palm, pear, plum, redbud, and redwood trees, or the female cultivars of ash, box elder, cottonwood, maple, palm, poplar, or willow trees.

Seasonal Allergies: Nuisance or Real Health Threat?

For most people, hay fever is a seasonal problem—something to endure for a few weeks once or twice a year. But for others, such allergies can lead to more serious complications, including sinusitis and asthma.

  • Sinusitis is one of the most commonly reported chronic diseases and costs almost $6 billion a year to manage. It is caused by inflammation or infection of the four pairs of cavities behind the nose. Congestion in them can lead to pressure and pain over the eyes, around the nose, or in the cheeks just above the teeth. Chronic sinusitis is associated with persistent inflammation and is often difficult to treat. Extended bouts of hay fever can increase the likelihood of chronic sinusitis. But only half of all people with chronic sinusitis have allergies.
  • Asthma is a lung disease that narrows or blocks the airways. This causes wheezing, shortness of breath, coughing, and other breathing difficulties. Asthma attacks can be triggered by viral infections, cold air, exercise, anxiety, allergens, and other factors. Almost 80 percent of people with asthma have allergies, but we do not know to what extent the allergies trigger the breathing problems. However, some people are diagnosed with allergic asthma because the problem is set off primarily by an immune response to one or more specific allergens. Most of the time, the culprit allergens are those found indoors, such as pets, house dust mites, cockroaches, and mold. Increased pollen and mold levels have also been associated with worsening asthma.

Diagnosis

Testing for Allergies

Knowing exactly what you are allergic to can help you lessen or prevent exposure and treat your reactions. There are several tests to pinpoint allergies:

  • Allergy skin tests—Allergy skin testing is considered the most sensitive testing method and provides rapid results. The most common test is the “prick test,” which involves pricking the skin with the extract of a specific allergen, then observing the skin’s reaction.
  • Serum-specific IgE antibody testing—These blood tests provide information similar to allergy skin testing.

Treatment

For allergy sufferers, the best treatment is to avoid the offending allergens altogether. This may be possible if the allergen is a specific food, like peanuts, which can be cut out of the diet, but not when the very air we breathe is loaded with allergens, such as ragweed pollen. Various over-the-counter or prescription medications can relieve symptoms.

  • Antihistamines. These medications counter the effects of histamine, the substance that makes eyes water and noses itch and causes sneezing during allergic reactions. Sleepiness was a problem with the oldest antihistamines, but the newest drugs do not cause such a problem.
  • Nasal steroids. These anti-inflammatory sprays help decrease inflammation, swelling, and mucus production. They work well alone and, for some people, in combination with antihistamines; in recommended doses, they are relatively free of side effects.
  • Cromolyn sodium. A nasal spray, cromolyn sodium can help stop hay fever, perhaps by blocking release of histamine and other symptom-producing chemicals. It has few side effects.
  • Decongestants. Available in capsule and spray form, decongestants may reduce swelling and sinus discomfort. Intended for short-term use, they are usually used in combination with antihistamines. Long-term usage of spray decongestants can actually make symptoms worse, while decongestant pills do not have this problem.
  • Immunotherapy. Immunotherapy (allergy shots) might provide relief for patients who don’t find relief with antihistamines or nasal steroids. Allergy shots alter the body’s immune response to allergens, thereby helping to prevent allergic reactions. They are the only form of treatment that can induce long-lasting protection for several years after therapy is stopped. Current immunotherapy treatments are limited because of potential allergic reactions; rarely, these can be severe.

Is It a Cold or an Allergy?


Symptoms Cold Airborne Allergy
Cough Common Sometimes
General Aches, Pains Slight Never
Fatigue, Weakness Sometimes Sometimes
Itchy Eyes Rare or Never Common
Sneezing Usual Usual
Sore Throat Common Sometimes
Runny Nose Common Common
Stuffy Nose Common Common
Fever Rare Never
Duration 3 to 14 days Weeks (for example, 6 weeks for ragweed or grass pollen seasons)
Treatment Cold Airborne Allergy
AntihistaminesDecongestantsNonsteroidal anti-inflammatory medicines AntihistaminesNasal steroidsDecongestants
Prevention Cold Airborne Allergy
Wash your hands often with soap and water.Avoid close contact with anyone with a cold. Avoid those things that you are allergic to, such as pollen, house dust mites, mold, pet dander, cockroaches.
Complications Cold Airborne Allergy
Sinus infectionMiddle ear infectionAsthma exacerbation Sinus infectionAsthma exacerbation

Seasonal Allergy Research at NIH

  • Asthma and Allergic Diseases Cooperative Research Centers: In 1971, the National Institute of Allergy and Infectious Diseases (NIAID) established its Asthma and Allergic Diseases Centers to conduct basic and clinical research on the mechanisms, diagnosis, treatment, and prevention of asthma and allergic diseases.
  • Immune Tolerance Network (ITN): The ITN is an international consortium of investigators in the United States, Canada, Europe, and Australia dedicated to the development and evaluation of novel, tolerance-inducing therapies in such disorders as asthma and allergic rhinitis.
  • Inner-City Asthma Consortium: Since 1991, the NIAID has funded research on asthma in inner-city areas with the goal of improving the treatment of children living in environments where the prevalence and severity of asthma is particularly high.
  • Allergen Epitope Research and Validation Centers: The goal of this NIAID program is to identify the portions of allergy-inducing molecules that immune system cells and IgE antibodies recognize, and to develop therapies that block these portions from causing allergic reactions.

To Find Out More

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CDC’s new antismoking campaign: Tips from Former Smokers

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This week the US Centers for Disease Control and Prevention (CDC) launches a new ad campaign featuring the stories of former smokers living with smoking-related diseases and disabilities.

“Tips from Former Smokers” ads will run for at least 12 weeks on television, radio, and billboards, online, and in theaters, magazines, and newspapers nationwide.

The education campaign seeks to provide motivation, information, and quit help to those who want it, CDC officials said.

  • The ads feature smoking-related health conditions— including chronic obstructive pulmonary disease or COPD, more severe adult asthma, and complications from diabetes, such as blindness, kidney failure, heart disease, and amputation—and candidly describe the losses from smoking and the gains from quitting
  • Despite the known dangers of tobacco use, nearly one in five adults in the United States still smoke.  Almost 90 percent of smokers started before they were 18, and many of them experience life-changing health effects at a relatively early age. Smoking harms nearly every organ in the body.
  • More than 440,000 Americans each year lose their lives to smoking-related diseases, and for every one death 20 more continue living with one or more serious illnesses from smoking.  Nearly 70 percent of smokers say they want to quit.

For more information on the campaign, including profiles of the former smokers, links to the ads, and free quit help, visit www.cdc.gov/tips.

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White Bread by Ricardo Perina

What you need to know about gluten and celiac disease

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By Lola O’Rourke, MS, RD
Valley Medical Center 

Celiac Disease (CD) is the result of an immune system response to the ingestion of gluten, a protein found in wheat, rye and barley.

When people with CD ingest gluten, this auto-immune response causes damage to the small intestine, reducing the body’s ability to absorb nutrients, leading to many of the most common symptoms of CD.

If left untreated, CD can have serious long term health consequences.

The symptoms of CD are extremely varied, and mirror symptoms for other conditions too. This is, in part, why it often takes a long time for CD to be diagnosed – the average length of time it takes for a diagnosis is about four years.

To complicate matters, many people with CD do not have obvious symptoms at all – they may have anemia or low bone density, conditions which may present during a routine medical exam.

Some of the most common symptoms include diarrhea, constipation, bloating, weight loss, anemia, chronic fatigue, infertility, migraines, bone pain and muscle cramps.

It’s estimated that about 1 percent of the U.S. population has Celiac Disease; the vast majority of these cases are undiagnosed. To develop CD, it’s necessary to have a genetic predisposition, to be consuming gluten and to have the disease activated by a triggering event such as surgery, illness, or even stress.

The first step to diagnosing CD is a blood test ordered by your physician which will look for the presence of antibodies that are indicative of CD. If these tests suggest CD, a biopsy of the small intestine is recommended to determine if the intestinal cells show damage consistent with this condition.

The biopsy is considered the “gold standard” for a CD diagnosis. If the biopsy does indicate CD, a gluten-free diet is warranted. Part two of the “gold standard” CD diagnosis is if the patient experiences improvement on a gluten-free diet.

People who experience adverse reactions to gluten but test negative for celiac disease may have a condition called non-celiac gluten sensitivity (NCGS). Symptoms tend to overlap with those of CD, however, in the case of NCGS an intestinal biopsy would be negative.

Treatment for NCGS is also a gluten-free diet. The recognition and classification of NCGS is quite new and more research is needed, but estimates claim the incidence of NCGS is up to 6 or 7 times higher than that of CD.

The “good” news about CD (and NCGS) compared with many other medical conditions is that it can be treated by diet. (Note: In some cases, especially the newly diagnosed, nutritional supplements and/or other medications may be required to treat related conditions: consult with your primary care physician and dietitian.)

What’s sometimes viewed as “bad” news (often for the newly diagnosed) is that it MUST be treated by diet. The only known treatment is a strict gluten-free diet. Although a gluten-free diet may seem restrictive at first, you can still enjoy a wide range of delicious foods, and in time, it will seem second nature.

There is a wealth of good information available to help people live a healthy and satisfying gluten-free life. The Gluten Intolerance Group (GIG) is a non-profit organization that provides an extensive range of educational information on numerous aspects of celiac disease and other gluten-related disorders, including how to eat safely in restaurants, what to do about gluten in medications, and how to use gluten-free grains.

Visit www.gluten.net for information, recipes and listings of certified gluten-free products. GIG also has a network of support groups around the country.

Getting involved with a support group can be very helpful in terms of learning about local gluten-free resources (grocery stores, products, restaurants), as well as for sharing stories and getting support, especially during the early stages of learning about the gluten-free diet.

PHOTO: White bread by Ricardo Perina

A local GIG Branch meets at Valley Medical Center the third Tuesday of every month from 7:00 to 9:00pm. For more information contact Lynn Jameson: Southseattlegfgroup@yahoo.com.

About Lola O’Rourke, MS, RD

Lola O’Rourke is a registered dietitian who specializes in gluten-free eating, weight management and family meal planning. During her twenty-five year career in food and nutrition she has provided nutrition expertise to public health agencies, food businesses, school districts and individuals. Lola is bilingual in Spanish and has lived and worked in Mexico and Latin America. She recently served as a national media spokesperson for the American Dietetic Association and conducted over 300 interviews with venues including The New York Times, MSNBC, USA Today and Latina magazine. She’s been an avid baker and dessert fan since her teens, became gluten-free as an adult and now integrates these interests into healthful and delicious eating plans for her clients.

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Egg cracked

Hope for beating egg allergy

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From NIH Research Matters

Giving small daily doses of egg powder to children with egg allergy could pave the way to letting them eat the food safely, a new study finds.

This would make life easier on kids whose only current option is to stay away from all foods that contain eggs.

Egg allergy is one of the most common food allergies in children. There’s no treatment other than completely avoiding the food.

That’s tough for children, parents and caregivers; eggs can lurk in everything from marshmallows to salad dressing.

And the stakes are high. Children who are allergic to eggs can have reactions ranging from hives to anaphylaxis, a life-threatening condition with symptoms that include throat swelling, a sudden drop in blood pressure, trouble breathing and dizziness.

One possible way to help people with food allergies is oral immunotherapy.

In this still-experimental approach, patients eat gradually increasing amounts of the food they’re allergic to. A research team led by Dr. A. Wesley Burks at the University of North Carolina and Dr. Stacie M. Jones at the University of Arkansas for Medical Sciences tested oral immunotherapy for children who are allergic to eggs.

The study was funded by NIH’s National Institute of Allergy and Infectious Disease (NIAID), National Center for Research Resources (NCRR) and the National Center for Advancing Translational Sciences (NCATS).

The researchers recruited 55 children, ages 5 to 18, who were allergic to eggs. Forty of the participants ate daily doses of raw egg-white powder. The others received cornstarch as a placebo.

Researchers increased the dose every 2 weeks until the children on oral immunotherapy were eating the equivalent of about one-third of an egg every day.

At 10 months, the participants went into the clinic, where they were “challenged” with increasing doses of egg-white powder and watched closely for symptoms.

As reported in the July 19, 2012, issue of the New England Journal of Medicine, more than half of the children who had been eating egg powder daily passed the challenge, with no allergic reaction or only minor symptoms.

ral food challenges should not be tried at home because of the risk of severe allergic reactions.”A year later, 30 children passed a challenge with an even larger dose of egg powder. In contrast, none of the children in the placebo group passed the challenge.

Those 30 children stopped oral immunotherapy and were told to avoid all eggs for 4 to 6 weeks. Then they faced another challenge: a dose of egg powder and a whole cooked egg.

Most kids had allergic reactions, but 11 passed the test and were allowed to eat as many eggs or egg-containing foods as they wanted in their normal diets. A year later, those children reported they still had no problems eating eggs.

The study suggests 2 ways that egg oral immunotherapy could help children. First, while they were eating the daily dose of egg powder, most of the children could safely eat eggs. Second, a small group of children—about 1 in 4—were able to eat eggs even after the daily oral immunotherapy ended.

“Although these results indicate that oral immunotherapy may help resolve certain food allergies, this type of therapy is still in its early experimental stages and more research is needed,” says Dr. Daniel Rotrosen, director of NIAID’s Division of Allergy, Immunology and Transplantation. “We want to emphasize that food oral immunotherapy and oral food challenges should not be tried at home because of the risk of severe allergic reactions.”

RELATED LINKS:

Reference: N Engl J Med. 2012 Jul 19;367(3):233-43. PMID: 22808958

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People with asthma get the green light for exercise

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Illustration of the lungs in blueBy Christen Brownlee, Contributing Writer
Health Behavior News Service

Not only is it safe for people with asthma to exercise, but doing so could reduce their risk of asthma symptoms or attacks, according to a new evidence review in The Cochrane Library.

Many people with asthma report avoiding exercise because they’re afraid it could trigger symptoms including shortness of breath, wheezing or a full-blown asthma attack, said review author Kristin V. Carson.

These fears might be encouraged from misreading their symptoms, their family’s beliefs about exercise and asthma, or even from their physicians.

Over time, Carson explains, patients can become out of shape, losing muscle mass and cardiovascular fitness. That makes any future attempts at physical activity significantly harder, increasing the chances that patients will become fatigued and breathless and further discouraging physical activity.

“This results in a spiraling cycle,” she says, in which patients are even more likely to avoid exercise.

To determine whether exercise was a danger to asthmatics, Carson and her colleagues reviewed previous studies that looked at the effects of physical training on people with asthma , comparing patients who received no or minimal physical activity to those who exercised for at least 20 minutes, twice a week, over the course of four weeks.

The researchers found that the patients who had exercised—using physical training as varied as running outdoors or on a treadmill, cycling, swimming or circuit training—were no more likely to have a serious asthma-related problem than those who weren’t exercising or who did light exercising such as yoga.

Additionally, Carson said, their findings showed that patients in exercise programs improved their cardiovascular fitness, which in turn could reduce asthma symptoms over time.

Some limited evidence from the included studies also suggested that exercise improved patients’ quality of life, she added, which could contribute to other health benefits and improved psychological well-being.

“We found no reason for people with stable asthma to refrain from regular exercise,” Carson said. “Physicians should encourage their patents with stable asthma to engage in physical training programs.”

Len Horowitz, M.D., a pulmonary specialist at Lenox Hill Hospital in New York City who wasn’t involved in this review, agrees that asthma patients shouldn’t shy away from exercise.

However, even though research suggests that exercise is safe for asthmatics, he says that many people will still use their asthma as a reason to avoid physical activity.

“Not everyone wants to exercise,” he said. “When patients think exercise makes them symptomatic or makes them risk an attack, it’s a good excuse not to do it.”

Horowitz notes that may professional athletes have asthma, which hasn’t negatively affected their careers.

However, he explains, some patients do have exercise-induced asthma, in which vigorous or prolonged exercise can trigger symptoms.

He advises patients in his practice to take precautions if they’re susceptible, including pre-treating themselves with an albuterol inhaler, avoiding exercise that exposes their lungs to cold, dry air (such as running outside in the winter) and building their activity levels gradually.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

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Worm therapy for hay fever? More research is needed

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Hookworm (Photo: CDC)

By Katherine Kahn, Contributing Writer
Health Behavior News Service

Purposely infecting patients with hookworms or whipworms to treat hay fever and other immune-related diseases has been experimented with since the 1970s.

A new review by The Cochrane Library concludes that current evidence doesn’t yet support the use of this therapy.

However, worm therapy does appear to be safe, the review’s lead author says.

“Allergic diseases affect hundreds of millions of people worldwide, especially in industrialized countries,” says review author Ashley Croft, M.D., a public health physician at the headquarters of the Surgeon General, Whittington Barracks, in Lichfield, UK. “Existing treatments for allergies, which mostly involve pharmacotherapy, are often expensive, dangerous, or ineffective. If worm therapy can be shown to be effective and safe, it will represent an important new clinical option for treatment.”

Croft theorizes that worm therapy might work if having intestinal worms “‘tones up’ the immune system of their human hosts, so that the host stops being over-responsive to common allergens. This helps the worms avoid detection and destruction by the host’s immune system.”

“Up until the 20th century, everybody had worms.”

Joel Weinstock, M.D., chief of gastroenterology at Tufts University Medical Center in Boston, is one of the few researchers in the United States investigating the use of worm therapy in immune-related diseases.

“It’s generally appreciated that in the 20th century a whole series of immunological diseases have emerged out of nowhere,” Weinstock explains, including hay fever, asthma, inflammatory bowel diseases, and multiple sclerosis. “Why did these diseases emerge? If you look around the world, these diseases are fairly common in industrialized countries, but in less developed countries, they are relatively rare.”

 Key Points

  • Since the 1970s, worm therapy has been used as an alternative treatment for hay fever under the assumption that it might calm overactive immune systems.
  • No long-term studies have been conducted to demonstrate that worm therapy relieves hay fever symptoms.
  • An evidence review of available studies of worm therapy shows no benefit for hay fever sufferers, and that while safe it may cause minor digestive problems.

The cause, Weinstock believes, is the tremendous improvement in hygiene—and that includes lack of exposure to intestinal worms, such as hookworms and whipworms. “Up until the 20th century, everybody had worms,” Weinstock says.

The lack of worm infections in modern societies, Weinstock conjectures, has led to over-reactive immune systems and an increase in immune-related diseases.

Croft’s review examined evidence from two placebo-controlled, double blinded studies that enrolled a total of 130 adults who had either intermittent or persistent allergic rhinitis.

One study used hookworm larvae, which enter through the skin and travel to the intestines and the other study used pig whipworm eggs that participants swallowed.

Participants who used worm therapy had no reduction in hay fever symptoms or percentage of days when symptoms were minimal. They also had no changes in lung function or quality of life scores.

Croft cautions that these studies are too small to truly evaluate effectiveness. “It did come as a surprise, therefore, that we found that people with allergic rhinitis who took worms were less likely to have to take tablets as rescue medication during the grass pollen season.”

Weinstock also says that the studies to date haven’t been designed very well and says it was surprising researchers found any response at all since the study follow-up times were too short.

“To treat an allergy, you probably have to have a treatment strategy that’s at least six months long,” before evaluating effectiveness, he says. The studies ran for only three months and six months, respectively, after initiating worm therapy.

“Our main finding was that worm therapy is safe,” says Croft. “In participants who took worms there were some gastrointestinal side effects, such as abdominal pain and diarrhea, but these were transient and were not so severe as to cause people to drop out of the trials.”

Croft says that there is enough evidence to support continued research in worm therapy. “Clinical trials in worm therapy are not expensive to run and the potential benefits from this new form of therapy are very great,” he says.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

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Viewpoint: For sufferer’s of Morgellons disease, what next?

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By William E. Scott

“Bugs,” the two year old boy said as he pointed to an irritated patch of skin on his face. Mary Leitao looked closer, and although she found no visible insects, she was startled to find colored fibers sprouting from her son’s skin. It was a summer evening in 2001 that would change the lives of the Leitao family for years to come.

A medical researcher turned stay-at home mom, Leitao had never seen anything like it and neither had her husband, Edward, an internist at South Allegheny Internal Medicine.  Mary Leitao took her son to be examined by numerous doctors, but none provided a satisfactory explanation. Many suggested that it was a form of psychosis called “delusional infestation” or the conviction of being infected with parasites.

Images from the CDC study in PLoS One

Believing instead that she had discovered a new disease, Leitao named the condition Morgellons and in 2004 established a non-profit organization called the Morgellons Research Foundation (MRF).

Through the efforts of the MRF, the CDC (Centers for Disease Control and Prevention) conducted a three-year government study to research Morgellons.

The results, released last week, indicated that there was no diseased organisms or parasites present in the 115 case-patients.

The protruding fibers were found to be mostly skin fragments or clothing fibers stuck to the skin.

According to the report, the physical ailments were manifestations of “delusional infestation.”

From a recent article in WebMD, individuals with delusional infestation tend to be hyper-aware of normal body sensations and interpret them as medical illness.  The article notes, “This stress has real physical effects on the body and leads to a spiral of worsening physical symptoms…”

The suggestion that thoughts and stress can be manifested as physical maladies may be counterintuitive to anatomy-based medicine, but research increasingly supports the idea. For instance, The Washington Post reported, “Nocebos[inert pills provided with a negative expectation] often cause a physical effect, but it’s not a physically produced effect,” said Irving Kirsch, a psychologist at the University of Connecticut in Storrs who studies the ways that expectations influence what people experience.

The CDC study, published by the open-access journal PLoS One, is available online.

The CDC also has an information page about Morgellons Disease.

The idea that the condition may be more mental than physical has always been unpopular among those who identify themselves with the disease. It has impelled them to fight on two fronts – working to gain credibility and help from the medical community and fighting the unfortunate stigma of mental illness.  With the significant setback of the CDC report, how many may be wondering, what next?  

I have compassion for those suffering from Morgellons.  No one should have to live with the painful symptoms or the mental anguish of feeling isolated, abandoned and uncared for. Yet, perhaps it’s time to consider the mental nature of the condition. Yet, perhaps it’s time to consider the mental nature of the condition. But I’m not proposing psychotherapy – but a spiritual approach.”

For instance, in the recent Jan. 29 issue of the Concord Monitor, a woman describes her recovery from disease as she changed her thought to a more prayerful perspective.  Shifting thought away from the body to seeking a greater understanding of her spiritual nature worked for her.

As the mental factors of many diseases become more widely understood, spiritual treatments, such as Christian Science, that focus on thought can be a valuable resource. The MRF website reports that fear and hopelessness are common among those who suffer from Morgellons. Working spiritually to lessen and eliminate these unhealthy mental states may be the best next step.

This article first appeared on Blogcritics.

A retired architect, Bill Scott writes about spirituality and health for Blogcritics.org and also serves as the Christian Science Committee on Publication for Washington State.

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Stagnant winter air poses health risk to many, health officials warn

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Illustration of the lungs in blueSmoke and exhaust trapped close to the ground by stagnant winter air can can harm people with heart disease, diabetes, asthma, and lung diseases, Washington State Department of Health officials warn. Children and older adults may also be at risk, they said.

November through March winter weather often causes stagnant air that traps air pollution from outdoor burning, wood stoves, and fireplaces gets trapped near the ground, officials said.

Who is at highest risk?

Breathing polluted air can cause short and long-term health problems. People with heart and lung diseases are more likely to develop serious health problems. Sometimes, older adults have heart or lung disease that they’re not aware of, and it puts them at risk. Kids spend more time outside, where they’re exposed to air pollution for longer periods. Children’s lungs are more easily damaged because they’re still developing.

Exercise and air pollution:

When air quality is poor, people should limit outdoor activities and reschedule them for a time when air quality is better. When people exercise, they breathe more air and air pollution into their lungs. If you decide to exercise, choose a less strenuous exercise such as going for a walk instead of a run. And avoid exercising in higher pollution areas such as near highways or in neighborhoods with a lot of wood smoke.

How to check air quality

Be sure to check air quality (http://www.airwatchnw.org) before heading out for outdoor activities, especially if you’re in a high-risk group. Often air pollution can’t be seen or smelled, so it’s hard to judge air pollution levels.

Burn bans:

Several burn bans have been issued across the state recently because of poor air quality. Smoke contains fine particles and toxic gases that can be breathed deep into lungs. Some counties in the state are under a burn ban. Before you burn, check to see if your county is under a burn ban (www.waburnbans.net).

To learn more:

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Mildew from a wooden soap dish - Photo by Bob Baylock

Removing mold helps reduce asthma and respiratory infections — study

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Mildew from a wooden soap dish - Photo by Bob Baylock

By Glenda Fauntleroy, Contributing Writer
Health Behavior News Service

A new evidence review finds that ridding homes and offices of mold and dampness can help reduce respiratory infections and troubling symptoms for asthma sufferers across the globe; however, the best way to eliminate the mold remains unclear.

Mold is one of the most important environmental triggers of symptoms such as coughing and wheezing, according to National Institute of Environmental Health Sciences.

“Mold is found in many homes with basements, in apartments and walkouts that are partially or fully below ground, and in buildings that have been flooded or have poor humidity control,” said Peter Thorne, head of the occupational and environmental health department at the University of Iowa. “Homes and office buildings alike have problems.”

But does “remediating” or relieving homes, offices and schools of dampness and mold make a big difference? Lead reviewer Riitta Sauni at the Finnish Institute of Occupational Health in Tampere, Finland, said that results are mixed.

PHOTO: Bob Baylock under Creative Commons license

Key Points:

  • Ridding homes and office buildings of mold can reduce the incidence of respiratory illness and decrease asthma-related symptoms, a new Cochrane review finds.
  • While removing mold from offices and homes can reduce coughing and wheezing, the best method for mold removal remains to be determined.
  • Mold can be costly to remove from buildings, which can be re-infected even after cleaning and fungicide treatments.

“We were happy to find evidence that remediation of mold-damaged houses decreased the severity and amount of symptoms in patients with asthma and respiratory infections,” Sauni said. “Unfortunately, we did not find evidence that remeditation could prevent these diseases.”

The review appears in the September issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

Remediation of mold and dampness requires total or partial renovation of a building, or cleaning with a fungicide or bleach solution. Sauni and her team looked at eight studies with 6,538 participants who had their homes, schools or workplaces remediated by a mixture of these methods.

The reviewers say that because the available studies did not offer high-quality evidence and sample sizes were small, “drawing hard conclusions was difficult.”

Nonetheless, the review found that when compared to doing nothing at all, repairing houses decreased asthma-related symptoms as well as the amount of respiratory infections in adults.

Remediation also decreased the number of acute care visits in children and students’ visits to physicians for common colds.

In one South Wales study, for instance, 115 members of the group who had their homes remediated with the complete removal of visible mold, a fungicide treatment and installation of a fan, were more likely to see improvement in their respiratory symptoms for six and 12 months afterwards, compared to those in the control group whose homes were not cleaned.

The reviewers, however, could not determine which method of remediation was superior to significantly improving asthma symptoms.

“The studies have shown that after cleaning and fungicide treatment, a large number of the buildings were soon re-infected with molds, and also a partially remediated office building had to be repaired more thoroughly,” Sauni said, adding that mold removal can be costly.

“Sometimes, if the structures are damaged widely, the easiest and most cost-effective possibility is to pull down the damp building and build a new one,” she said.

The reviewers concluded that better research is necessary to give evidence of improved outcomes.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

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Just what is ‘gluten-free’?

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A Consumer Update from the U.S. Food and Drug Administraion

Whether in muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, says Stefano Luccioli, M.D., a Food and Drug Administration (FDA) allergist and immunologist. They need to know whether a food contains gluten.

FDA has been working to define “gluten-free” to:

  • eliminate uncertainty about how food producers may label their products.
  • assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.

FDA’s actions on Aug. 2 bring the agency one step closer to a standard definition of “gluten-free.” On this date:

  • FDA reopens the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007.
  • FDA makes available, and seeks comments on, a report on the health effects of gluten in people with celiac disease. The report includes a safety assessment on levels of gluten sensitivity in people with the disease.

Naturally Gluten-Free

Some foods are naturally free of gluten. Here are some examples:

  • milk not flavored with ingredients that contain gluten, such as malt
  • 100 percent fruit or vegetable juices
  • fresh fruits and vegetables
  • butter
  • eggs
  • lentils
  • peanuts
  • seeds, such as flax
  • tree nuts, such as almonds
  • non-gluten-containing grains, such as corn
  • fresh fish, such as cod
  • fresh shellfish, such as clams
  • honey
  • water, including bottled, distilled, and spring

Celiac Disease

According to the National Institutes of Health, celiac disease affects as many as 1 percent of the U.S. population.

The disease occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs.

Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia and osteoporosis. Other serious health problems may include diabetes, autoimmune diseases, and intestinal cancers.

“Some people don’t get immediate symptoms, but when they do, they are typically gastrointestinal-related, such as abdominal pain, bloating, and diarrhea,” says Luccioli. “In infants, there may be a lot of vomiting, and they don’t grow and thrive.”

And some people do not have any symptoms at all, adds Luccioli, but still may have intestinal damage and risk for long-term complications.

It is important for individuals with celiac disease, who may vary in their sensitivity to gluten, to discuss their dietary needs with their health care professional.

Grocery shopping is challenging for people with this disease, says Andrea Levario, J.D., executive director of the American Celiac Disease Alliance. “When they find a product labeled ‘gluten-free,’ they don’t necessarily know what that means because today there is no federal standard for the use of this term.”

Having a federal definition of “gluten-free” is critically important, says Levario. “If we have one national standard, the individual will know that all products labeled ‘gluten-free’ will have no more than a minimal amount of gluten.”

Is Gluten-Free for Me?

“Eating gluten-free is not meant to be a diet craze,” says Rhonda Kane, a registered dietitian and consumer safety officer at FDA. “It’s a medical necessity for those who have celiac disease.”

“There are no nutritional advantages for a person not sensitive to gluten to be on a gluten-free diet,” she adds. “Those who are not sensitive to gluten have more flexibility and can choose from a greater variety of foods to achieve a balanced diet.”

Gluten-free is not synonymous with low fat, low sugar, or low sodium. For people who must be on a gluten-free diet, Kane says it’s important to check the ingredients list and Nutrition Facts information on food labels to find the most nutritious options.

How Is FDA Proposing to Define ‘Gluten-Free’?

In 2007, FDA proposed to allow manufacturers to label a food “gluten-free” if the food does not contain anyof the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
  4. 20 ppm or more gluten

In the notice reopening the comment period, FDA states that it continues to believe the proposed definition of “gluten-free” is the correct one.

FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods.

The agency is interested in hearing from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days. To submit comments electronically, go to www.regulations.gov and

  1. choose “Submit a Comment” from the top task bar
  2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
  3. select “Search”

After FDA reviews and considers the comments, the agency will issue a final rule that defines “gluten-free” for labeling food products, including dietary supplements.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Aug. 2, 2011

Consumer Updates on Nutrition and Healthy Diets

For More Information

Examples of Celiac Disease and Gluten Intolerance Organizations and Support Groups

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