Category Archives: Vitamins & Supplements

Lead-warning for children’s herbal cold and flu remedy from China

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From the Washington Department of Health

The U.S. Food and Drug Administration (FDA) has sent out an alert regarding Bo-Ying Compound after traces of lead were found in the product. Bo-Ying Compound is used to treat a wide variety of conditions in infants and children.

boying (1)

The Washington State Department of Health received an alert regarding lead found in Bo-Ying Compound manufactured by Eu Yan Sang (Hong Kong).

This product is also manufactured by other companies and may also contain lead so people are urged not to use any Bo-Ying Compound products. Continue reading

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States ask U.S. Congress to launch inquiry of herbal supplements | Reuters

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Ginkgo bilobaA group of 14 state attorneys general on Thursday asked the U.S. Congress to investigate the herbal supplements industry after a New York probe of the products turned up ingredients that were not listed on labels and raised safety concerns.

via States ask U.S. Congress to launch inquiry of herbal supplements | Reuters.

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Beware of products promising miracle weight loss – FDA

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A Consumer Update from the US Food and Drug AdministrationScale

“This year, I’m going to lose some weight.”

If you find yourself making this common New Year’s resolution, know this: many so-called “miracle” weight loss supplements and foods (including teas and coffees) don’t live up to their claims.

Worse, they can cause serious harm, say FDA regulators.

The agency has found hundreds of products that are marketed as dietary supplements but actually contain hidden active ingredients (components that make a medicine effective against a specific illness) contained in prescription drugs, unsafe ingredients that were in drugs that have been removed from the market, or compounds that have not been adequately studied in humans.

“When the product contains a drug or other ingredient which is not listed as an ingredient we become especially concerned about the safety of the product,” says James P. Smith, M.D., an acting deputy director in FDA’s Office of Drug Evaluation.

Tainted products

Continue reading

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New study again finds higher rate of rare neurological birth defects in central Washington

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Washington MapA new study has again found a higher rate of a rare neurological birth defect, anencephaly, in Yakima, Benton and Franklin counties, Washington state health officials said Tuesday.

The study identified seven cases of the birth defect in these three counties in 2013, which translates into a rate of 8.7 per 10,000 births. That rate is similar to the rate seen in 2010-2012 and remains well above the national rate of 2.1 per 10,000 births, health officials said. Continue reading

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Can a dietary supplement treat a concussion? No

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Illustration of the skull and brainA Consumer Update from the US Food and Drug Administration

Exploiting the public’s rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease.

The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes.

These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA’s National Health Fraud Coordinator.

“We’re very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready,” says Coody. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional.

The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion.

Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

“As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster,” says Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs.

The Claims

One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.

“We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue,” says Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. “That sparked our surveillance.”

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family.

For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have “the world’s first supplement formulated specifically to assist concussion recovery,” saying “it has the dynamic ability to minimize long-term effects and decrease recovery time.”

A National Football League player testified to its “proven results in my own recovery” from a concussion, and an unnamed “licensed trainer” said he had incorporated it into his “concussion management protocol.”

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

“As we continue to work on this problem, we can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” says Coody. “If someone tells you otherwise, walk away.”

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

Dec. 31, 2013

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Teens and steroids: a dangerous combo

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Contraband anabolic steroids seized by the Drug Enforcement Agency. (Photo: DEA)

US Food and Drug Administration
Consumer Update

The abuse of anabolic steroids can cause both temporary and permanent injury to anyone using them.

Teenagers, whose bodies are still developing, are at heightened risk. An alarming number of them are trying steroids in hopes of improving their athletic prowess or their appearance.

Ali Mohamadi, M.D., a medical officer in the Food and Drug Administration’s Division of Metabolism and Endocrinology Products, warns teens and parents about the dangers of steroid use.

Q: What are anabolic steroids and how many teens use them?

A: They are drugs that mimic the actions of the male sex hormone testosterone. This includes promoting the growth of cells, especially in muscle, and maintaining or increasing male physical characteristics. Various studies have been conducted and generally reflect the findings of a Youth Risk and Behavior Surveillance System study, which estimated that among U.S. high school students, 4.9% of males and 2.4% of females have used anabolic steroids at least once in their lives. That’s 375,000 young men and 175,000 young women.

Q. What are the side effects of taking anabolic steroids?

A: They are known to have a range of serious adverse effects on many organ systems, and in many cases the damage is not reversible. They include fertility problems, impotence, high blood pressure and cholesterol, and heart and liver abnormalities. Boys may experience shrinkage of the testes or the development of breast tissue; girls may experience menstrual irregularities and development of masculine qualities such as facial and body hair. Both may experience acne. Both boys and girls may also experience mood swings and aggressive behavior, which can impact the lives not only of those taking steroids, but of everyone around them.

Q: Are prescriptions needed to get steroids?

A: Yes, in fact anabolic steroids are classified as Schedule III Controlled Substances by the U.S. Drug Enforcement Administration with strict regulations, meaning that not only is a prescription required, but there are extra controls. For example, it is illegal to possess them without a prescription in the United States, and in most circumstances the prescription must be in written form and cannot be called in to a pharmacist. Labels on some steroids recommend testing of hormone levels during use.

The number of FDA-approved uses is limited. Most are prescribed as a replacement for sub-normal levels of steroids. They are also prescribed for conditions such as muscle wasting, poor wound healing, and very specific pulmonary or bone marrow disorders.

A health care professional can prescribe steroids off-label, meaning for conditions other than those that are FDA-approved. But children, particularly teens, are getting access to steroids and taking them for reasons far outside of their intended use.

Q: So how are teens getting access?

A: Some get prescriptions from a licensed practitioner for such purposes as introducing puberty to boys who are “late bloomers” or to stimulate growth among teens who are failing to grow. Some may be dealing with unscrupulous clinics or street dealers on the black market. Unfortunately, a number of vendors sell anabolic steroids online without a prescription. Individuals should also be aware that some dietary supplements advertised for body building may unlawfully include steroids or steroid-like substances, and the ingredient statement on the label may not include that information.

Q: What is the FDA doing to prevent those illegal sales?

A: FDA is taking a number of steps to discourage these practices. Action has been taken against illegal online distributors who sell steroids without valid prescriptions, but an ongoing problem is that you can take one site down and another pops up.

The challenge is intensified by the fact that many online providers don’t accurately advertise the contents of the products they sell, they may be operating outside the U.S., and the drugs aren’t prescribed by a licensed practitioner who can help individuals weigh the risks and benefits. In such cases, individuals may have no idea what they are taking, what the appropriate dose should be, or what levels of control and safety went into the manufacturing process. These facts make the risks of taking anabolic steroids bought without a prescription even greater than they otherwise would be.

Q: What would you say to a teen you knew was tempted by steroids?

A: I would emphasize both the short and long-term potential for serious harm to their health. Rather than making you look or perform better, steroids will more likely cause unfavorable results that could affect you for life. I would also remind them that there are a number of ways to increase muscle mass and athletic performance, including a sensible regimen of exercise and diet, without resorting to extreme and dangerous therapies.

Q: What would you like to say to parents?

A: Parents tend not to believe their teens would consider taking anabolic steroids, but the truth is that the frequency of steroid use in this age group is far greater than many would guess.

During this time of year, when children are in school and getting back into their athletic routines, parents should watch for potential signs of abuse. Mood swings are among the first side effects to show up, and steroid use may lead to mania or depression. Acne is also an early side effect and can be followed by breast development in boys or increased body hair in girls. A surprising gain of muscle mass should also raise questions. It’s a problem that is as real as it is surprising.

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

Nov. 4, 2013

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National Prescription Drug Take-Back Day Oct. 26 offers safe disposal of medications

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From the Snohomish Health District 

Snohomish County hosts National Prescription Drug Take-Back Day activities:

An extra chance to securely dispose of unwanted medications is offered Saturday, Oct. 26 at police stations and some pharmacies throughout Snohomish County.

Residents are encouraged to clean out their medicine cabinets and take unused prescriptions to secure disposal locations coordinated by the Snohomish County Partnership for Secure Medicine Disposal.

All sites will accept unwanted vitamins, pet medications, over-the-counter medications, inhalers, and unopened EpiPens as well as controlled substances such as painkillers. 

Site locations and times are available at www.takebackyourmeds.org or by calling 425.388.3199. 

“Law enforcement, public health, and environmental professionals support take-back programs as the safest and most responsible way to get rid of unwanted and expired medicines that might otherwise harm people or the environment,” said Jonelle Fenton-Wallace, the Snohomish Health District representative on the Snohomish Regional Drug & Gang Task Force.

In addition to twice-yearly drug take-back days, all law enforcement locations in the county take back unwanted medicines, including controlled substances, throughout the year Monday through Friday. 

Year-round drop-off locations include the NCIS office at Naval Station Everett for those with access, Washington State Patrol office in Marysville, and tribal police stations on the Tulalip and Stillaguamish reservations.

The year-around, countywide drop-off sites have collected more than 9 tons of unwanted drugs since 2009. Year-round locations can be found a twww.snohd.org by searching for “unwanted medicine”.

The Snohomish County Partnership for Secure Medicine Disposal addresses growing community concern about abuse, accidental poisonings, overdoses and contamination of water from unwanted medications.

Year-round programs ensure that residents have ongoing access to safe disposal of unwanted and expired medicines. The partners agree that long-term success is dependent on sustainable funding for a statewide program. In some countries, drug-return programs are funded by pharmaceutical manufacturers.

Partnership members include the Snohomish Health District, Snohomish County, the Snohomish County Sheriff’s office, the Snohomish Regional Drug and Gang Task Force, the Washington State Patrol, and all local law enforcement agencies.

Established in 1959, the Snohomish Health District works for a safer and healthier Snohomish County through disease prevention, health promotion, and protection from environmental threats. Find more information about the Health District at www.snohd.org. 

DEA National Drug Take-Back Day Oct. 26

Locations & Times

 

City: Arlington

Time: 11  am – 1  pm

Location: Arlington Police Department

110 East Third Street

Arlington, WA 98223

 

City: Edmonds

Time: 9  am – 1  pm

Location: Edmonds Police Department

250 Fifth Avenue North

Edmonds, WA 98020

 

City: Everett

Time: 8  am – noon

Location: Everett Police Department – North Precinct

3002 Wetmore Avenue

Everett, WA 98201

 

City: Granite Falls

Time: 10  am – 2  pm

Location: Granite Falls Police Department

205 South Granite Avenue

Granite Falls, WA 98252

 

City: Lake Stevens

Time: 9  am – 1  pm

Location: Bartell Drugs (hosted by Lake Stevens Police Department)

621 SR 9 NE

Lake Stevens, WA 98258

 

City: Lynnwood

Time: 8  am – noon

Location: Lynnwood Police Department

19321 44th Avenue West

Lynnwood, WA 98036

 

City: Marysville

Time: 1  pm – 3  pm

Location: Marysville Police Department

1635 Grove Street

Marysville, WA 98270

 

City: Mill Creek

Time: 9  am – 1  pm

Location: Snohomish County Sheriff – South Precinct

15928 Mill Creek Blvd

Mill Creek, WA 98012

 

City: Mountlake Terrace

Time: 8  am – noon

Location: Mountlake Terrace Police Department

5906 232nd Street SW

Mountlake Terrace, WA 98043

 

City: Snohomish

Time: 8  am – noon

Location: Snohomish Police Department

230 Maple Avenue

Snohomish, WA 98290

 

City: Sultan

Time: 11  am – 2  pm

Location: Sultan Police Department

515 Main Street

Sultan, WA 98294 

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Women’s Health – Week 6: Bone Health and Osteoporosis

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From the Office of Research on Women’s Health

Bones are living tissue. A healthy body with strong bones is essential to overall health and quality of life. Strong bones support us and protect the heart, lungs, brain, and other organs from injury. Weak bones break easily. They cause pain and interrupt everyday activities.

Osteoporosis, or porous bone, is a disease characterized by low bone mass. It makes bones weak and more likely to break – especially the bones of the hip, spine, and wrist.

The disease is a major public health threat for an estimated 44 million Americans, 68 percent of whom are women. Every year, 1.5 million Americans suffer a fracture because of weak bones, mostly in the wrists, spine, and hips.

Osteoporosis is called a silent disease because bone loss occurs without symptoms. People typically do not know that they have osteoporosis until their bones become so weak that a sudden strain, twist, or fall results in a fracture (broken bone). Many people are unaware of the link between a broken bone and osteoporosis.

While white women over the age of 50 are at highest risk for osteoporosis, women and men of every age and ethnicity should be concerned about bone health.

If you are older than 65, have broken a bone after age 50, have relatives with a broken bone, have certain medical conditions (for example, hyperthyroidism or arthritis), or take certain prescription medications (such as thyroid medicine or glucocorticoids), you may be at higher risk for osteoporosis. Talk to your health care provider and find out if you need a bone density test.

osteoporosis

Diagram showing a healthy spine versus a spine showing signs of osteoporosis. Click on the image to view larger.

Some steps you can take to help prevent osteoporosis and fractures:

  • Be physically active every day to keep your bones strong. Weight-bearing physical activity causes new bone tissue to form, which makes bones stronger.
  • Eat a healthy diet, including calcium and vitamin D, which are critical for good bone health.
  • Know that smoking and heavy alcohol use reduce your bone mass and increase your risk for broken bones.
  • Reduce your risk of falling with physical activity to make you stronger and to improve your balance and coordination (making you less likely to fall).
  • Make your home safe by removing things you can trip over (like small rugs and stepstools), using non-slip mats in the bathtub and shower, and installing bright light bulbs to make it easier to see.
  • Ask a health care provider to review your prescription and over-the-counter medicine because some medicines, or combinations of medicines, can make you less alert, slower to react, and can lead to a fall.
for more information: www.niams.nih.gov
NIH and You
Milk matters is a public health education campaign that promotes calcium consumption among tweens and teens, especially between the ages of 11 to 15, a time of critical bone growth. Bones grow fastest during the tween and teen years, and adequate calcium intake during these years helps prevent osteoporosis later in life. But, studies show that most tweens and teens are not getting enough of it in their diets. Fewer than one in ten girls and only one in four boys ages 9 to 13 are at or above their adequate intake of calcium. Although the consequences of low calcium consumption may not be visible in childhood, the Eunice Kennedy Shriver National Institute of Child Health and Human Development recognizes lack of calcium during the critical years of bone development can have a serious effect on the health of young people later in life.

 
for more information: www.nichd.nih.gov/milk

 

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Washington teens getting their whooping cough immunizations; HPV vaccinations lag

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From the Washington State Department of Health

Vaccination_of_girlImmunization rates for Washington teens improved for some vaccines, while holding steady for others, according to a new national study.

In 2012, 86 percent of teens aged 13–17 in our state got a Tdap booster, according to the National Immunization Survey. That’s up from 75 percent in 2011 and tops the national goal of 80 percent.

Tdap is the vaccine that protects against tetanus, diphtheria and whooping cough (pertussis). The increase is welcome news following the recent whooping cough epidemic in Washington.

“We’re delighted that more teens in our state are protected against whooping cough,” said State Health Officer Dr. Maxine Hayes. “Older kids and teens often spread the disease to babies without knowing it. That’s why it’s so important for teens to get a dose of the Tdap vaccine.”

Over the last couple years, more teen girls are getting all three doses of the HPV vaccine, but fewer are getting the initial shot. About 43.5 percent of Washington girls 13 to 17 received the recommended three doses of the vaccine, up 3.5 percent from 2011.

Yet, only 64.5 percent of girls in the same age group got one dose of the HPV vaccine, a 2 percent decrease over the same time.

In 2012, nearly 15 percent of Washington boys aged 13–17 got the first HPV vaccine dose, up 6 percent from 2011. HPV vaccine was originally licensed only for girls and was made available to boys in October 2011.

This, plus a lack of knowledge by health care professionals and parents on the need and recommendation to vaccinate boys, may be why the rate for boys is lower than girls.

HPV vaccinations are recommended for girls and boys to protect against cervical cancer, genital warts and other types of oral and anal cancers.

Health care professionals should talk with parents about the importance of all kids getting HPV vaccinations starting at age 11 and 12. Kids in this age group have a stronger immune response compared to older kids.

“Parents want what’s best for their kids and want them to live happy, healthy lives,” Hayes said. “They can lower their children’s risk for HPV or cancer by getting them vaccinated.”

Nearly all sexually-active men and women will get at least one type of HPV at some point in their lives. HPV is most common in people in their teens and early 20s. That’s why it’s important for kids to get vaccinated before they start having sex. The vaccine doesn’t protect against any HPV strains someone already has.

Our state’s vaccination rate for two or more doses of chickenpox vaccine rose 8 percent in 2012. The rate for one dose of meningococcal vaccine rose slightly, from 69.4 percent in 2012 to 71.2 percent in 2011.

No-cost vaccines are available to kids up to 19-years-old through health care providers who participate in the state’s Childhood Vaccine Program.

Participating health care providers may charge for the office visit and an administration fee to give the vaccine. People who can’t afford the administration fee can ask for it to be waived.

For help finding a health care provider or an immunization clinic, call your local health agency or the WithinReach Family Health Hotline at 1-800-322-2588.

 

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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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FDA launches new consumer outreach website

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An FDA Consumer Update

You may know that the Food and Drug Administration (FDA) is responsible for protecting your health by ensuring that the food you eat is safe, and that the drugs and medical products you and your family use are safe and effective.

But did you also know that FDA needs your help?

“It’s true,” says Richard Klein, director of FDA’s Patient Liaison Program within the Office of Health and Constituent Affairs. “We invite consumers to get involved in the process of helping FDA make the decisions that affect their lives.”

And thanks to FDA’s Patient Network initiative, it’s easy.

According to Klein, FDA has a long history of working with patients and patient advocates representing specific groups, beginning with the AIDS crisis of the 1980s.

Since then, FDA has reached out to advocacy groups, such as the National Council of Rare Health Disorders and other disease-specific groups, to ask for their input on proposed regulations and guidance documents.

More recently, in July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) which calls for the agency to increase patient participation in the regulation of medical products.

According to project manager James Valentine, M.H.S., the Patient Network helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA.

There are a number of ways to become involved, including becoming a patient representative on a committee that advises FDA on key issues.

Valentine explains that the three-phase program began in 2011 with the launch of the twice-monthly newsletterPatient Network News.

A recent issue includes information on a product that has been linked to potentially serious eye infections; an upcoming public meeting on breast cancer; a story on active ingredients in children’s medicines; and information on pet health.

“It’s a good way to find out just what FDA is up to—and in ways that are relevant to you, the individual,” Valentine says.

The annual Patient Network meeting, the second of which will take place this summer, is the second phase. “We’re gearing up for it now,” Klein notes.

By popular demand from patient organizations, Klein says, the meeting will focus on “demystifying the FDA, by providing a basic primer about medical product regulation.”

“We need to demonstrate that from both FDA’s and industry perspectives medical product development isn’t a simple 1-2-3 recipe,” he adds.

Phase 3 is the FDA Patient Network website, to launch the week of April 22, 2013. The website is an interactive tool for educating patients, patient advocates and consumers on how their medications and medical devices go from idea to the shelf.

FDA launched the site to engage patients and consumers as partners, and encourage them to share ideas and concerns about the medical product development process.

“When it comes to FDA’s regulatory process, we feel very strongly patients should have a say,” notes Klein. “The new website provides an excellent place to start.”

According to Klein, consumers have complained that they find it difficult to locate the information they need on the agency’s website, and when they do, it is targeted for industry use.

“This website provides a concentrated, one-stop forum from which we can reach patients and vice versa,” Valentine says. The website connects patients, caregivers, and advocacy groups to the agency through e-mail, webinars, live chats, open meetings and announcements of opportunities for patients to comment on FDA regulations.

There are sections on what FDA does, FDA advisory committees, FDA initiatives, and frequently asked questions. The website also helps patients, caregivers, and advocacy groups find information on:

  • getting involved in the regulatory process;
  • finding relevant clinical trials;
  • finding additional treatment options;
  • getting information about diseases; and
  • getting information about their medications, including whether they have been issued a warning label or recalled from the market, whether there are other, off-label uses of the drug, or if anyone has had an adverse reaction to their medication.

“We’ve worked hard to make it easily navigable and user friendly,” Valentine says.

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

April 23, 2013

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Poison prevention tips from the American Academy of Pediatrics

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From the American Academy of Pediatrics

National Poison Prevention Week, March 18 – 24, 2012

Each year, approximately 2.4 million people – more than half under age 6 – swallow or have contact with a poisonous substance. The American Academy of Pediatrics (AAP) has some important tips to prevent and to treat exposures to poison.

To poison proof your home:

Poison logoMost poisonings occur when parents or caregivers are home but not paying attention. The most dangerous potential poisons are medicines, cleaning products, antifreeze, windshield wiper fluid, pesticides, furniture polish, gasoline, kerosene and lamp oil.

Be especially vigilant when there is a change in routine. Holidays, visits to and from grandparents’ homes, and other special events may bring greater risk of poisoning if the usual safeguards are defeated or not in place.

  • Store medicine, cleaners, paints/varnishes and pesticides in their original packaging in locked cabinets or containers, out of sight and reach of children.
  • Install a safety latch – that locks when you close the door – on child-accessible cabinets containing harmful products.
  • Purchase and keep all medicines in containers with safety caps and keep out of reach of children. Discard unused medication.
  • Never refer to medicine as “candy” or another appealing name.
  • Check the label each time you give a child medicine to ensure proper dosage.
  • Never place poisonous products in food or drink containers.
  • Keep coal, wood or kerosene stoves in safe working order.
  • Maintain working smoke and carbon monoxide detectors.
  • Secure remote controls, key fobs, greeting cards, and musical children’s books. These and other devices may contain small button-cell batteries that can cause injury if ingested.

Treatment

If your child is unconscious, not breathing, or having convulsions or seizures due to poison contact or ingestion, call 911 or your local emergency number immediately.

If your child has come in contact with poison or you suspect that your child may have swallowed a button-cell battery, and has mild or no symptoms, call your poison control center at 1-800-222-1222

Different types and methods of poisoning require different, immediate treatment:

  • Swallowed poison – Remove the item from the child, and have the child spit out any remaining substance. Do not make your child vomit. Do not use syrup of ipecac.
  • Skin poison — Remove the child’s clothes and rinse the skin with lukewarm water for at least 15 minutes.
  • Eye poison — Flush the child’s eye by holding the eyelid open and pouring a steady stream of room temperature water into the inner corner for 15 minutes.
  • Poisonous fumes – Take the child outside or into fresh air immediately. If the child has stopped breathing, start cardiopulmonary resuscitation (CPR) and do not stop until the child breathes on his or her own, or until someone can take over.
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6 Tip-offs to rip-offs: Don’t fall for health fraud scams

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Miracle cureBogus product! Danger! Health fraud alert!

You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “revolutionary scientific breakthrough,” or “alternative to drugs or surgery.”

Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer.

According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose.

Scammers promote their products through newspapers, magazines, TV infomercials and cyberspace. You can find health fraud scams in retail stores and on countless websites, in popup ads and spam, and on social media sites like Facebook and Twitter.

Not Worth the Risk

Health fraud scams can do more than waste your money. They can cause serious injury or even death, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.”

Coody says fraudulent products often make claims related to:

  • weight loss
  • sexual performance
  • memory loss
  • serious diseases such as cancer, diabetes, heart disease, arthritis and Alzheimer’s

A Pervasive Problem

Fraudulent products not only won’t work—they could cause serious injury. In the past few years, FDA laboratories have found more than 100 weight-loss products, illegally marketed as dietary supplements, that contained sibutramine, the active ingredient in the prescription weight-loss drug Meridia. In 2010, Meridia was withdrawn from the U.S. market after studies showed that it was associated with an increased risk of heart attack and stroke.

Fraudulent products marketed as drugs or dietary supplements are not the only health scams on the market. FDA found a fraudulent and expensive light therapy device with cure-all claims to treat fungal meningitis, Alzheimer’s, skin cancer, concussions and many other unrelated diseases. Generally, making health claims about a medical device without FDA clearance or approval of the device is illegal.

“Health fraud is a pervasive problem,” says Coody, “especially when scammers sell online. It’s difficult to track down the responsible parties. When we do find them and tell them their products are illegal, some will shut down their website. Unfortunately, however, these same products may reappear later on a different website, and sometimes may reappear with a different name.”

Tip-Offs

FDA offers some tip-offs to help you identify rip-offs.

  • One product does it all. Be suspicious of products that claim to cure a wide range of diseases. A New York firm claimed its products marketed as dietary supplements could treat or cure senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, dysuria, and lung, cervical and prostate cancer. In October 2012, at FDA’s request, U.S. marshals seized these products.
  • Personal testimonials. Success stories, such as, “It cured my diabetes” or “My tumors are gone,” are easy to make up and are not a substitute for scientific evidence.
  • Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days” or “eliminates skin cancer in days.”
  • “All natural.” Some plants found in nature (such as poisonous mushrooms) can kill when consumed. Moreover, FDA has found numerous products promoted as “all natural” but that contain hidden and dangerously high doses of prescription drug ingredients or even untested active artificial ingredients.
  • “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “scientific breakthrough” or “secret ingredient.” If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals—not buried in print ads, TV infomercials or on Internet sites.
  • Conspiracy theories. Claims like “The pharmaceutical industry and the government are working together to hide information about a miracle cure” are always untrue and unfounded. These statements are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure.

Even with these tips, fraudulent health products are not always easy to spot. If you’re tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first.

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

March 4, 2013

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Prostate Cancer: Facts and fiction

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Six Myths about prostate cancer

When it comes to prostate cancer, there’s a lot of confusion about how to prevent it, find it early and the best way – or even whether – to treat it. Below are six common prostate cancer myths along with research-based information from scientists at Fred Hutchinson Cancer Research Center to help men separate fact from fiction.

Myth 1 – Eating tomato-based products such as ketchup and red pasta sauce prevents prostate cancer. 

“The vastmajority of studies show no association,” said Alan Kristal, Dr.P.H., associate director of the Hutchinson Center’s Cancer Prevention Program and a national expert in prostate cancer prevention.

Kristal and colleagues last year published results of the largest study to date that aimed to determine whether foods that contain lycopene – the nutrient that puts the red in tomatoes – actually protect against prostate cancer.

After examining blood levels of lycopene in nearly 3,500 men nationwide they found no association. “Scientists and the public should understand that early studies supporting an association of dietary lycopene with reduced prostate cancer risk have not been replicated in studies using serum biomarkers of lycopene intake,” the authors reported in Cancer Epidemiology, Biomarkers & Prevention.  “Recommendations of professional societies to the public should be modified to reflect the likelihood that increasing lycopene intake will not affect prostate cancer risk.”

Myth 2 – High testosterone levels increase the risk of prostate cancer.

“This is a hypothesis based on a very simplistic understanding of testosterone metabolism and its effect on prostate cancer. It is simply wrong,” Kristal said.

Unlike estrogen and breast cancer, where there is a very strong relationship, testosterone levels have no association with prostate cancer risk, he said.

A study published in 2008 in the Journal of the National Cancer Institute, which combined data from 18 large studies, found no association between blood testosterone concentration and prostate cancer risk, and more recent studies have confirmed this conclusion.

Myth 3 – Fish oil (omega-3 fatty acids) decreases prostate cancer risk. 

“This sounds reasonable, based on an association of inflammation with prostate cancer and the anti-inflammatory effects of omega-3 fatty acids,” Kristal said.

However, two large, well-designed studies – including one led by Kristal that was published last year in the American Journal of Epidemiology – have shown that high blood levels of omega-3 fatty acids increase the odds of developing high-risk prostate cancer.

Analyzing data from a nationwide study of nearly 3,500 men, they found that those with the highest blood percentages of docosahexaenoic acid, or DHA, an inflammation-lowering omega-3 fatty acid commonly found in fatty fish, have two-and-a-half times the risk of developing aggressive, high-grade prostate cancer compared to men with the lowest DHA levels.

“This very sobering finding suggests that our understanding of the effects of omega-3 fatty acids is incomplete,” Kristal said.

Myth 4 – Vitamins and dietary supplements can prevent prostate cancer. 

Several large, randomized trials that have looked at the impact of dietary supplements on the risk of various cancers, including prostate, have shown either no effect or, much more troubling, they have shown significantly increased risk.

“The more we look at the effects of taking supplements, the more hazardous they appear when it comes to cancer risk,” Kristal said. For example, the Selenium and Vitamin E Cancer Prevention Trial (SELECT), the largest prostate cancer prevention study to date, was stopped early because it found neither selenium nor vitamin E supplements alone or combined reduced the risk of prostate cancer.

A SELECT follow-up study published last year in JAMA found that vitamin E actually increased the risk of prostate cancer among healthy men.

The Hutchinson Center oversaw statistical analysis for the study, which involved nearly 35,000 men in the U.S., Canada and Puerto Rico.

Myth 5 – We don’t know which prostate cancers detected by PSA (prostate-specific antigen) screening need to be treated and which ones can be left alone.

 “Actually, we have a very good sense of which cancers have a very low risk of progression and which ones are highly likely to spread if left untreated,” said biostatistician Ruth Etzioni, Ph.D., a member of the Hutchinson Center’s Public Health Sciences Division.

“For the majority of newly diagnosed cases of prostate cancer, by taking into account initial clinical and biopsy information we can get a very good idea of who should be treated and who is likely to benefit from deferring treatment.”

In addition to blood levels of PSA, indicators of aggressive disease include tumor volume (the number of biopsy samples that contain cancer) and Gleason score (predicting the aggressiveness of cancer by how the biopsy samples look under a microscope). Gleason scores range from 2-5 (low risk) and 6-7 (medium risk) to 8-10 (high risk).

“Men with a low PSA level, a biopsy Gleason score of 6 or lower and very few biopsy samples with cancer are generally considered to be very low risk,” Etzioni said.

Such newly diagnosed men increasingly are being offered active surveillance – a watchful waiting approach – rather than therapy for their disease, particularly if they are older or have a short life expectancy.

“The chance that these men will die of their disease if they are not treated is very low, around 3 percent,” she said. Similarly, such men who opt for treatment have a mortality rate of about 2 percent. “For the majority of newly diagnosed cases of prostate cancer, by taking into account initial clinical and biopsy information we can get a very good idea of who should be treated and who is likely to benefit from deferring treatment.”

Myth 6 – Only one in 50 men diagnosed with PSA screening benefits from treatment.

“This number, which was released as a preliminary result from the European Randomized Study of Prostate Cancer Screening, is simply incorrect,” Etzioni said. “It suggests a very unfavorable harm-benefit ratio for PSA screening. It implies that for every man whose life is saved by PSA screening, almost 50 are overdiagnosed and overtreated.”

“The correct ratio of men diagnosed with PSA testing who are overdiagnosed and overtreated versus men whose lives are saved by treatment long term is more likely to be 10 to one.”

“Overdiagnosis” is diagnosing a disease that will never cause symptoms or death in the patient’s lifetime. “Overtreatment” is treating a disease that will never progress to become symptomatic or life-threatening.

The 50-to-one ratio, which is based on short-term follow-up data, “grossly underestimates” the lives likely to be saved by screening over the long term and overestimates the number of men who are overdiagnosed, Etzioni said.  “The correct ratio of men diagnosed with PSA testing who are overdiagnosed and overtreated versus men whose lives are saved by treatment long term is more likely to be 10 to one.”

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