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:

• Online: www.fda.gov/medwatch/report.htm

• 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

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

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

To learn more:

• Decorative Contact Lenses

• FDA Educational Flyer: Buying Contact Lenses Without a Prescription is Dangerous! (PDF – 108KB)

• Contact Lenses: No Prescription, No Way (video from American Academy of Ophthalmology—AAO)

• Halloween Contact Lenses Can Be Scary for Your Eye Health (video from AAO)

• Halloween Hazard (from AAO)

For related FDA Updates 

• ‘Lucky 13’ Tips for a Safe Halloween

Photo by the QFamily

If you eat food contaminated with bacteria called Listeria, you could get so sick that you have to be hospitalized. And for certain vulnerable people, the illness could be fatal.

Unlike most bacteria, Listeria germs can grow and spread in the refrigerator. So if you unknowingly refrigerate Listeria-contaminated food, the germs could contaminate your refrigerator and spread to other foods there and increase the likelihood that you and your family will become sick.

Those most at risk for listeriosis—the illness caused by Listeria monocytogenes—include pregnant women, older adults and people with compromised immune systems and certain chronic medical conditions (such as HIV/AIDS, cancer, diabetes, kidney disease, and transplant patients).

In pregnant women, listeriosis can cause miscarriage, stillbirth, and serious illness or death in newborn babies.

Recently, a multi-state outbreak of listeriosis tied to contaminated cantaloupes has caused illnesses and deaths. Listeria has also been linked to a variety of ready-to-eat foods, including unpasteurized milk and dairy products, Mexican-style or soft cheeses made with unpasteurized milk, processed deli meats, hot dogs, smoked seafood and store-prepared deli-salads.

Listeria monocytogenes

Donald Zink, Ph.D, senior science advisor at FDA’s Center for Food Safety and Applied Nutrition, says FDA is aware of cases of foodborne illness caused by bacteria that can live in the kitchen and spread to foods.

Consumers are advised to wash all fruits and vegetables under running water just before eating, cutting or cooking, even if you plan to peel the produce first. Scrub firm produce such as melons and cucumbers with a clean produce brush.

To further protect yourself and your family from Listeria, follow these steps:

Keep Refrigerated Foods Cold

Chilling food properly is an important way of reducing risk of Listeria infection. Although Listeria can grow at refrigeration temperatures, it grows more slowly at refrigerator temperatures of 40 degrees F or less.

• Keep your refrigerator at 40 degrees F or lower and the freezer at 0 degrees F or lower.
• Wrap or cover foods with a sheet of plastic wrap or foil or put foods in plastic bags or clean covered containers before you place them in the refrigerator. Make certain foods do not leak juices onto other foods.
• Place an appliance thermometer, such as a refrigerator thermometer, in the refrigerator, and check the temperature periodically.  Adjust the refrigerator temperature control, if necessary, to keep foods as cold as possible without causing them to freeze. Place a second thermometer in the freezer to check the temperature there.
• Use precooked and ready-to-eat foods as soon as you can. The longer they are stored in the refrigerator, the more chance Listeria has to grow.

“If you have leftovers in your refrigerator, it’s best to throw them out after three days, just to be sure,” says Zink. “It’s better to be safe than sorry.”

Clean Refrigerator Regularly

Listeria can contaminate other food through spills in the refrigerator.

• Clean up all spills in your refrigerator right away—especially juices from hot dog and lunch meat packages, raw meat, and raw poultry. Consider using paper towels to avoid transferring germs from a cloth towel.
• Clean the inside walls and shelves of your refrigerator with warm water and liquid soap, then rinse. As an added measure of caution, you can sanitize your refrigerator monthly using the same procedures described below for kitchen surfaces.

Clean Hands and Kitchen Surfaces Often

Listeria can spread from one surface to another.

• Thoroughly wash food preparation surfaces with warm, soapy water. As an added precaution you should sanitize clean surfaces by using any of the kitchen surface sanitizer products available from grocery stores, being careful to follow label directions.

You can make your own sanitizer by combining 1 teaspoon of unscented bleach to one 1 quart of water, flooding the surface and letting it stand for 10 minutes.  Then rinse with clean water.  Let surfaces air dry or pat them dry with fresh paper towels.  Bleach solutions get less effective with time, so discard unused portions daily.

• A cutting board should be washed with warm, soapy water after each use. Nonporous acrylic, plastic, or glass boards can be washed in a dishwasher.
• Dish cloths, towels and cloth grocery bags should be washed often in the hot cycle of your washing machine.
• It’s also important, to wash hands with warm water and soap for at least 20 seconds before and after handling food.

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

Posted September 30, 2011

PHOTO CREDIT: Cantalope by the QFamily.

Vibrio parahaemolyticus - Janice Carr/CDC

Washington State health officials are warning distributors, retailers, restaurants, and consumers not to eat, sell, or ship oysters harvested between August 30 and September 19 from Washington’s Hood Canal growing area #4,

The state Department of Health closed oyster harvesting in the area after five people who ate raw oysters containing Vibrio parahaemolyticus got sick with an illness called vibriosis.

The recall is a precautionary action to make sure that no oysters in the shell harvested from Hood Canal #4, in this time period, are still for sale or in the hands of consumers, health officials said.

Vibrio parahaemolyticus bacteria are found naturally in the environment. When water temperature rises, the bacteria can quickly grow to a level that causes illness.

Symptoms:

Symptoms of vibriosis include diarrhea, abdominal cramps, nausea, vomiting, headache, fever, and chills. The symptoms usually appear about 12 hours after eating infected shellfish, but they can begin within two hours or as late as 48 hours after consumption. The illness is usually moderate and lasts for two to seven days; however, it can be more serious, even life threatening to people with weak immune systems or chronic liver disease. Taking certain medications may make vibriosis more likely to occur after eating shellfish.

Harvested shellfish should be kept cool, health officials said, and thorough cooking kills the bacteria, making the shellfish safe to eat.

Food safety specialists recommend oysters be cooked to an internal temperature of 145° F to kill the bacteria.

More information:

Go to the agency’s shellfish safety website (http://www.doh.wa.gov/ehp/sf/default-sf.htm), which includes maps showing areas closed to harvesting.

Note: It’s important to remember that just because an area doesn’t appear to be closed because of Vibrio parahaemolyticus, it may be closed for marine biotoxins

Therefore, check the Department of Health’s biotoxin Web page (http://ww4.doh.wa.gov/gis/mogifs/biotoxin.htm) to make sure an area you wish to harvest in is free from marine biotoxins.

To learn about Vibriosis, go to the U.S. Centers for Disease Control and Prevention’s webpage on Vibrio parahaemolyticus.

Other resources:

• Washington State Department of Health’s  Shellfish Program website (www.doh.wa.gov/ehp/sf/default.htm)

• Department’s toll-free hotline 1-800-562-5632 for current shellfish safety information.