Category Archives: Product Recall

Avoid powdered pure caffeine, FDA warns.

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From the US Food and Drug Administration

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.

In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.

The FDA is aware of at least one death of a teenager who used these products.

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These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

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Inks found in certain tattoo kits cause infections – FDA

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tatoo inkConsumer Update from the US Food and Drug Administration

Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe.

But beware—there may be associated health risks.

Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks.

White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but FDA is still concerned that tattoo artists may be using contaminated inks from other distributors.

According to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection.

“FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.”

Risks Can Be Severe

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Hepatitis A case in Thurston County linked to frozen berries sold at Costco

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Costco berries

‘Townsend Farms Organic Anti-Oxidant Blend’ frozen berries have been linked the outbreak.

The Centers for Disease Control and Prevention (CDC) now believes there has been at least one case of hepatitis A illness in Washington State that may be linked to frozen berries sold at Costco.

“The probable case in our state is a man from Thurston County who was sick in March and has recovered,” the Washington State Department of Health reports.

The national outbreak now lists 79 cases in eight states linked to the product marketed as “Townsend Farms Organic Anti-Oxidant Blend” frozen berry and pomegranate mix.

According to the label, the brand contained products originating from the U.S., Argentina, Chile, and Turkey.

The product was also sold at Harris Teeter stores, the CDC reports, however, no cases have been identified that bought the product at Harris Teeter at this time.

For advice for consumers about the outbreak go to the CDC website.

The Department of Health advises against eating these berries and recommends discarding any remaining product from your freezers:

Even if some of the product has been eaten without anyone in your home becoming ill, the rest of the product should be discarded.

Contact your health care provider right away if you have eaten these berries and develop yellow eyes or skin, abdominal pain, diarrhea, pale stools, or dark urine. Symptoms can start up to seven weeks from the time of exposure.

If you consumed this product in the last two weeks and have never been vaccinated for hepatitis A or had the disease, contact your health care provider to find out if you should be vaccinated or receive other treatment.

If you have already received the hepatitis A vaccination in the past or had hepatitis A, you are unlikely to become ill with the disease.

People without a health care provider may contact the local health agency in their community. If it’s too late for a hepatitis A shot, be sure to wash hands thoroughly after using the toilet and don’t prepare food for others if you have diarrhea.

Follow this advice even if you get the vaccine in time. The latest information about the national hepatitis A outbreak is available on the Centers for Disease Control and Prevention website.

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E. coli outbreak leads to expanded recall of frozen food products

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Alert Icon with Exclamation Point!The Washington State Department of Health is warning people that several types of frozen food products – Farm Rich, Market Day, and Schwan’s brands – have been recalled due to possible contamination with E. coli.

 

The products were distributed widely throughout Washington.

The recalls are related to a national E. coli outbreak that sickened 27 people from 15 states, including a Pierce County woman in her 20s.

“The foods in this recall were sent to stores throughout our state,” said Dave Gifford, Food Safety program manager. “E. coli can be very serious. We’re asking people to look at the recall list, check their freezers carefully, and throw out any of these products that they find.”

The type of E. coli in this outbreak is a strain of Shiga toxin-producing E. coli O121 (STEC O121), which is similar to E. coli O157:H7.

It can cause diarrhea, abdominal cramps, bloody diarrhea, fever, and vomiting. It can sometimes result in severe, life-threatening illness.

The recalled product list continues to expand and now includes several varieties of frozen snacks and mini-meal products.

The full list of the products currently covered by the recall is on the U.S. Department of Agriculture’s website; more info is on the Food Safety Program website.

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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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FDA Updates Safety Recommendations for Metal-on-Metal Hip Implants

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An FDA Consumer Update

The US Food and Drug Administration has updated its safety information and recommendations to patients and health care professionals based on the agency’s current assessment of metal-on-metal hip implants, including:

  • the benefits and risks
  • the evaluation of published literature
  • the results of an FDA advisory panel meeting held in June 2012

Risk:

Implant components slide against each other during walking or running, which releases tiny metal particles. These particles may damage bone or soft tissue surrounding the implant and joint. Soft tissue damage could lead to pain, implant loosening, device failure and the need for revision surgery.

Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause discomfort or illnesses.

Recommendations for People Considering a Metal-on-Metal Hip Implant

  • Be aware that every hip implant has benefits and risks.
  • Discuss your options for hip surgery with your orthopedic surgeon.

Recommendations for People With Metal-on-Metal Hip Implants

  • If you are not having any symptoms and your orthopedic surgeon believes your implant is functioning properly, continue to follow-up routinely with the surgeon every one to two years.
  • If you develop new or worsening problems, such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip) or a change in your ability to walk, contact your orthopedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your doctor or other health care professional know you have a metal-on-metal hip implant.

For More Information

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5 things to know about breast implants

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A Consumer Update for the FDA

breast implantShould I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

Know the Basics

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

Know the Risks

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices.

The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.

Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. 

Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. 

FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

FDA’s Online Resources

FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:

  • Links to patient information and data for each product.
  • Information about risks and complications
  • Questions to ask health care professionals regarding breast implant surgery
  • Contact information for manufacturers of FDA-approved breast implants and related professional organizations

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

February 20, 2013

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Xmas toy safety tips from Seattle Children’s

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Toys that pose choking and other hazards to childrenDoctors’ toy safety tips for the holidays from Seattle Children’s On the Pulse blog

With an abundance of toys to choose from this holiday season, many parents may find themselves asking which toys are best for their young kids.

Pediatricians encourage parents – and anyone buying a gift for a baby or child – to think safety first.

Tony Woodward, MD, MBA, medical director of the division of emergency medicine at Seattle Children’s Hospital, says parents should read toy labels, remove possible hazards, and expect the unexpected when it comes to kids and toys.

“Parents should remember that children don’t perceive toys the same way we do and often don’t use them as we might expect,” says Woodward. “If a toy can be misused, chewed on, eaten, swallowed or thrown at someone, it will be. Parents should ensure that if those things do happen, the child won’t be injured.”

According to the U.S. Consumer Product Safety Commission (CPSC), there were more than 262,000 toy-related emergency room visits in the United States in 2011.

Woodward suggests parents keep these tips in mind when choosing toys for small kids:

Choking Hazards

Choking is the leading cause of toy-related deaths, according to the CPSC. In 2011, there were 13 reported toy-related deaths among children younger than 15 years in the United States, most from asphyxiation.

When choosing toys for small children, bigger is usually better:

  • Stay away from toys that contain many or small parts if there are small children in the household.
  • Be sure to read warning labels for age recommendations. Toys are age-graded to reflect safety risks, including choking hazards. A toy that may be appropriate for an older child can be potentially life-threatening for a baby or toddler.
  • Small balls are also particularly dangerous because they can block a child’s airway completely. “Water Balz,” for example, recalled earlier this week, absorb water and expand to 400 times their original size.

Woodward suggests this rule of thumb to help prevent choking: If a toy can fit inside a paper towel roll, the toy can obstruct the airway of a small child and prevent breathing.

Magnets

Toys that contain small magnets are especially dangerous for young kids. If swallowed, magnets can attract to one another in a child’s intestine and cause serious complications. Woodward says parents should look out for products like “Snake Eggs,” small magnets shaped like eggs that are marketed to children.

Button Batteries

Many toys and gadgets require button batteries, which can pose fatal risks for young kids. If a battery is swallowed, it can cause life-threatening injuries. Be sure batteries cannot be removed easily from toys.

Strangulation

Some toys have strings or cords that can become wrapped around a child’s neck and cause strangulation. Use caution with mobiles or pull toys with long string, and remove long ribbons from kids’ play areas.

Toys containing lead and other chemicals

Just like checking a food’s ingredient list, parents should read toy labels. Avoid products that contain PVC plastic, xylene, toluene, or dibutyl phthalate. Play cosmetics can be particularly hazardous.

Avoid toys and clothes that could contain lead paint or high levels of lead, such as vinyl lunch boxes or rain gear. To test products for lead, parents can purchase home testing kits, available at most local hardware shops. Buy paints, crayons and markers that say “non-toxic” on the label.

More toy safety tips

  • Include safety equipment with toys such as bikes, snowboards or skateboards. Helmets, elbow pads and knee pads make great stocking stuffers.
  • Avoid stuffed animals with buttons or removable parts.
  • Be cautious of toys that make loud noises. Toys that omit noise above 85 decibels can cause gradual hearing loss.
  • Consider the physical skills a child needs to play with a particular toy, and how well the child can understand how to use the toy.

Before wrapping presents this year, Woodward suggests parents review this checklist to help keep their kids safe: “Potential choking hazards should be removed, batteries and magnets should be inaccessible, toys that are sharp or can be used as weapons or projectiles should be removed and easily broken toys should be discarded.”

Toy safety resources:

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Sunland expands recall of products linked to Salmonella outbreak.

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Sunland, Inc. of Portales, New Mexico has expanded its nationwide recall of its products linked to a Salmonella outbreak, adding its cashew butter, tahini and roasted blanched peanut products to the recall list, which already includes the company’s almond butter and peanut butter products.

The products are sold under a variety of brand names, including Trader Joe’s, Archer Farms, and Sprout’s.

The company has posted a list of the recalled products here: www.sunlandinc.com/788/html/pdfs/SunlandRecall.pdf

The outbreak was first linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, a Sunland product, which Trader Joe’s pulled from its shelves last week.

According to the U.S. Centers for Disease Control and Prevention (CDC), 30 people in 19 states have been infected with the outbreak strain Salmonella Bredeney, including 2 in Washington state.

The number of ill persons identified in each state is as follows: Arizona (1), California (2), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (1), Nevada (1), New Jersey (2), New York (1), North Carolina (1), Pennsylvania (2), Rhode Island (1), Texas (4), Virginia (1), and Washington (2).

4 ill persons have been hospitalized, the CDC said, but no deaths have been reported.

The CDC recommends that “consumers do not eat recalled peanut butter and other products containing nuts and seeds and dispose of any remaining jars of product in the home or return the product to the place of purchase.”

“This is especially important for children under the age of 5 years, older adults, and people with weak immune systems,” the CDC said.

Sunland also advises consumers who have purchased the companies products subject to the recall should discard the product immediately.

Consumers can contact the company at 1-866-837- 1018, which is operational 24 hours a day, for information on the recall. In addition, a consumer services representative is available Monday through Friday between the hours of 8:00 AM and 5:00 PM MT at (575) 356-6638, the company said.

 

From the U.S. Food and Drug Administration:

What are the Symptoms of Salmonellosis?

Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment.

However, in some people, the diarrhea may be so severe that the patient needs to be hospitalized.

In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

Who is at Risk?

Children are the most likely to get salmonellosis.

The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons.

Young children, the elderly, and those with compromised immune systems are the most likely to have severe infections.

It is estimated that approximately 400 persons die each year with acute salmonellosis.

Who Should be Contacted?

Consumers who show any signs of illness from salmonellosis should consult their health care provider.

The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or consult the fda.gov website.

Additional resources:

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FDA urges that oysters, clams, mussels, and some scallops products from Korea should be removed from the market

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The U.S. Food and Drug Administration (FDA) is urging food distributors, retailers, and food service operators to remove from sale or service all fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States.

This includes molluscan shellfish from Korea that entered the United States prior to May 1, 2012, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that which may have inadvertently entered the country after that date.

These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.

Molluscan shellfish contaminated with fecal waste and/or norovirus are considered adulterated under the Federal Food, Drug, and Cosmetic Act.

Following initial notifications last month, a number of food companies have begun to remove these products from their distribution chain. However, many others have yet to take action.

A comprehensive FDA evaluation determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls specified under the United States’ National Shellfish Sanitation Program.

The FDA’s evaluation found significant deficiencies with the KSSP including inadequate sanitary controls, ineffective management of land-based pollution sources and detection of norovirus in shellfish growing areas.

The deficiencies in the KSSP prompted the FDA to remove all Korean certified shippers of molluscan shellfish from the ICSSL on May 1, 2012.

Although Korean molluscan shellfish represent only a small fraction of the oysters, clams, mussels, and scallops sold in the United States, the removal of Korean shellfish shippers from the ICSSL is an important step in stopping the importation of molluscan shellfish harvested from polluted waters.

  • Consumers who have recently bought molluscan shellfish and are concerned that it may have come from Korea, should contact the store where it was purchased and ask about its origin.
  • Consumers can check the label on packaged seafood to see if it is from Korea. If it is not clear where the product is from, consumers can call the manufacturer to find out.
  • Consumers should dispose of molluscan shellfish from Korea and any products made with molluscan shellfish from Korea.

These actions only affect molluscan shellfish harvested from Korean waters. They do not affect the receipt of fresh and frozen molluscan shellfish by distributors, retailers, and food service operators from any of the other shellfish shippers listed in the ICSSL.

Further, these actions do not affect the importation of canned and other processed product made with molluscan shellfish harvested from non-Korean waters. The FDA is in ongoing discussions with Korean authorities to resolve the issue.

Although the heat treatment that canned products undergo should eliminate the risk of norovirus, the contents of the cans of molluscan shellfish from Korea are still considered not fit for human food because the products were harvested from waters subject to human fecal contamination.

For fresh, frozen, or products processed by methods other than canning, the products should also be considered food not for human consumption and may also carry a risk of norovirus.

Norovirus

Norovirus virus particles/CDC

Noroviruses cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea, and stomach cramping.

Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms 12 to 48 hours after exposure to the virus.

The illness typically lasts one to three days. Dehydration is the most common complication, especially in young children and older adults, which may require medical care.

While there have been norovirus illnesses in the United States from the consumption of Korean oysters as recently as 2011, there have been no U.S. illnesses from the consumption of Korean shellfish reported in 2012.

About the FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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How does the FDA monitor your medical implants? It doesn’t, really.

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by Lena Groeger
ProPublica

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices.

In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market.

The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA.

But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leadsb(wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

“What you would normally consider the simplest kind of data analysis is not done.”

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices“

You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health.

An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney.

A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots.

Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart.

In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices.

Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago.

No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress.

A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

 

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Nearly 600,000 bottles of Infants’ Tylenol recalled

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McNeil Consumer Healthcare is recalling approximately 574,000 bottles of Infants’ Tylenol Oral Suspension, 1 oz. Grape, a popular pain reliever and fever reducer that is distributed nationwide in the United States.

The company issued the recall after receiving complaints from consumers who reported difficulty using the Infants’ Tylenol  SimpleMeasure dosing system.

SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose.

In some cases, the flow restrictor was pushed into the bottle when inserting the syringe, the company said.

Consumers can continue to use Infants’ TYLENOL provided the flow restrictor at the top of the bottle remains in place, the company said.

If, however, the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product, the company said.

The company has made a video on how to use the new dosing system - click on image to view.

No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote, the company said.

Consumers can request a refund by visiting www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information

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Recall includes Excedrin, NoDoz, Bufferin and Gas-X products

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The pharmaceutical company Novartis Consumer Health is recalling all lots of select bottle sizes of Bufferin, Excedrin, NoDoz, and Gas-X Prevention products distributed in the U.S., because the products may contain stray tablets, capsules, or caplets from other drugs, or contain broken or chipped tablets.

Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.

The recall includes:

  • Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well.
  • Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products, company officials said.

Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive reimbursement.

  • For more detailed information, consumers should visit the Novartis website at www.novartisOTC.com.
  • Additional information may also be found on the FDA website at www.fda.gov.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm — and the completed form mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
  • Fax: 1-800-FDA-0178
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Do baby products prevent SIDS? FDA says ‘No”

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A baby sleeping in a pink blanket

Photo by Debsch

An FDA Consumer Update

The best thing you can do to lower the chance of Sudden Infant Death Syndrome (SIDS) is to place your baby on his or her back to sleep, with nothing else in the crib or bassinet.

That’s the recommendation of the Food and Drug Administration (FDA), which is working to prevent manufacturers of over-the-counter sleep products for babies from claiming that their use will prevent or lower the chance of SIDS.

These products include infant positioners, mattresses, crib bedding, pillows, crib tents and baby monitors.

Baby products that claim to cure, treat or prevent any condition are considered medical devices, and are subject to FDA regulations designed to protect consumers and patients.

The agency has never approved a product to prevent SIDS—the unexplained death of a baby younger than age 1—and is asking manufacturers to stop marketing their products with these claims until they have received FDA clearance or approval, or to change their labeling to remove all medical claims.

“These products are absolutely not necessary and they can be very dangerous,” says Susan Cummins, M.D., M.P.H., chief pediatric medical officer in FDA’s Center for Devices and Radiological Health.

Dangerous comforts

FDA is aware of 13 infant deaths in the past 13 years associated with sleep positioners, which are used to keep the baby in a desired position. The Consumer Product Safety Commission has received reports of babies found in hazardous positions after being placed in a positioner.

Other products can also be hazardous. Babies can slide down and be trapped by wedges designed to keep them on their back, says Cummins. Blankets, quilts, soft toys and pillow-like crib bedding can smother, she adds.

It’s a matter of A-B-C, says Cummins:

  • Alone in their own bed. Don’t keep the infant in your bed next to you and risk that the baby will be accidentally suffocated if you roll over.
  • Back to sleep—every sleep. “The safest way to put the baby to sleep is on his or her back every time,” says Cummins. “Do not put the baby on his side or on his stomach.”

Since the national Back to Sleep campaign in 1994 urged parents to place babies on their backs, there has been a 60 percent reduction in SIDS, Cummins says.

  • Crib. The baby should always be placed in a crib or bassinet to sleep.

Cummins describes the ideal sleep environment for an infant as being free of anything that could block the infant’s movement or breathing.  All that’s needed is a firm crib mattress and a tight-fitting sheet.

To parents who have visions of a crib filled with comforts, she says, “Though a crib full of plush toys and soft bedding may look appealing to you, it is hazardous for your baby during his or her first year of life.”

“Your baby will develop faster in that first year than any time after. Newborns can’t even hold up their head, yet by their first birthday they are walking or nearly so,” says Cummins. “In between, your baby will learn to roll, sit, turn, crawl and even may start to climb!”

“So in that first year, your baby constantly and rapidly develops new skills, even in the crib during sleep time,” she says. “Make your baby’s crib a safe place to sleep and move, with nothing to get in the way.”

Safe Sleep Resources

FDA is starting a new website on SIDS prevention claims for parents, caregivers and manufacturers of sleep products for babies. Its purpose is to:

  • inform parents and caregivers about the risks associated with over-the-counter products that claim to prevent SIDS.
  • help manufacturers understand and comply with FDA laws and regulations governing medical devices, which are designed to protect consumers and patients.

The site also offers advice to parents on reducing the risk of SIDS and a list of “baby safe sleep” resources.

“The sleep environment is the one place where the baby is alone, so we want to make sure it’s safe,” says Cummins. And in this case, she says, less is more.

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

Posted October 17, 2011

PHOTO by Debsch

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Decorative contact lenses: Is your vision worth it?

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A Consumer Update from the FDA

Wouldn’t it be cool to have Twilight vampire eyes for Halloween?

Or deep violet eyes to match your purple sweater?

How about your favorite sports team’s logo on your eyes just for fun?

You can have all of these looks with decorative contact lenses (also called fashion contact lenses or color contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye.

But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law.

They are not “one size fits all.” An eye doctor (ophthalmologist or optometrist) must measure each eye to properly fit the lenses and evaluate how your eye responds to contact lens wear. A poor fit can cause serious eye damage, including:

    • scratches on the cornea (the top layer of your eyeball)
    • corneal infection (an ulcer on the cornea)
    • conjunctivitis (pink eye)
    • decreased vision
    • blindness

Places that sell decorative lenses without a prescription may give you few or no instructions on how to clean and care for your lenses.

Failure to use the proper solution to keep contact lenses clean and moist can lead to infections, says Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA. “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly.”

“The problem isn’t with the decorative contacts themselves,” adds Lepri. “It’s the way people use them improperly—without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care.”

Where NOT to Buy Contact Lenses

FDA is aware that many places illegally sell decorative contact lenses to consumers without valid prescriptions for as little as $20.

You should never buy lenses from:

  • street vendors
  • salons or beauty supply stores
  • boutiques
  • flea markets
  • novelty stores
  • Halloween stores
  • record or video stores
  • convenience stores
  • beach shops
  • Internet (unless the site requires a prescription)

These are not authorized distributors of contact lenses, which are prescription devices by federal law.

How to Buy Decorative Contact Lenses Safely

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Whether you go in person or shop online, buy the lenses from a seller that requires you to provide a prescription.

Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye doctor for follow-up eye exams.

See your eye doctor right away if you have signs of possible eye infection:

  • redness
  • eye pain that doesn’t go away after a short time
  • decrease in vision

High Price for Fashion

Laura Butler paid $30 for her decorative lenses and $2,000 in medical bills. And she nearly lost an eye.

While at the beach in July 2010, Butler of Parkersburg, W.Va., bought a pair of blue contact lenses at a souvenir shop. The brown-eyed Butler was on vacation and just wanted to try a different eye color for fun, she says.

No instructions came with the lenses and the store didn’t sell contact lens solution. “They felt fine, but they moved around on my eyes and I had to adjust them with my finger,” says Butler.

As she was driving home the next day, Butler felt a sharp pain in her left eye. “It was such excruciating pain, I had to quickly pull over on the side of the road.” It took her 20 minutes to remove the contacts, she says, which had stuck to her eyes like suction cups. She drove home “with pain that was indescribable.”

A trip to the ER and then to an ophthalmologist gave Butler a diagnosis: corneal abrasion. “The doctor said it was as if someone took sandpaper and sanded my cornea,” she says. “He said he wasn’t going to sugar-coat it, that I could lose my eyesight or could lose my eye.”

Butler saw the doctor every day for 10 days and was under his care for seven weeks. “He took really good care of me and I didn’t get an infection,” says Butler. “But the pain was agonizing. I used to lay on the floor and roll back and forth in a fetal position for hours.”

Butler couldn’t see well enough to drive for eight weeks, had a drooping eyelid for five months, and still has decreased vision in her eye, she says. And she found out her optometrist could have ordered two sets of lenses for $50 and charged $60 for an eye exam.

Her advice: Don’t buy fashion lenses. If you do, “Take the time to go to the doctor, pay the extra money, and save yourself the agony.”

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

October 12, 2011

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For related FDA Updates 

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