For Immediate Release: May 1, 2010
Media Inquiries: Elaine Ganz Bobo, 240.620.6896, Elaine.Bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA provides consumer advice following recall of products for infants and children

Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Following McNeil’s recall announcement on Friday evening, the FDA is providing additional advice to consumers.

“We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

What products are affected by this recall?
The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. For a complete list of recalled products, please see the recall notice¹.

Why were these products recalled?
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.

What can I use instead of the recalled products?
There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. FDA recommends that you check the labeling of these products. If you have any questions, you should discuss this with your pharmacist or other health care professional. FDA does not anticipate that there will be a shortage of alternative products.

Can I give my child adult strength Tylenol® or Motrin® products that are not being recalled?
No. Consumers should not give drug products to infants and children that are not intended for those age groups. This could result in serious harm.

What should I do if I have some of the medication at home?
FDA recommends that consumers stop using these products.
For further instructions, see McNeil’s website at: www.mcneilproductrecall.com²

I gave my child some of the medication. What do I do? Is my child at risk?
According to the information the FDA has received at this time, the potential for serious medical problems is remote. If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.

If I think my child may be having an adverse reaction to one of the products involved in this recall, who should I notify?
Adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this sheet. The agency asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch³.

Is Your Kid Truly Allergic? Tests Add to Food Confusion

• By MELINDA BECK

Grayson Grebe started getting eczema on his cheeks when he was just 4-weeks-old. At 6 months, he was diagnosed with allergies to wheat, dairy, eggs, nuts, oats, rice, barley, chicken, pork, corn and beans; his mother, who was breast-feeding him, had to stop eating them all. At 10 months, doctors cut out 20 more foods, including all fruits and vegetables, and put Grayson on a hypoallergenic formula. Even so, his eczema was so bad that his parents put him in mittens, long-sleeved shirts and long pants so no skin was exposed. “Otherwise, he’d scratch himself until he would bleed,” says his mother, Amy Grebe of Albuquerque, N.M.

At wit’s end, the Grebes took Grayson to National Jewish Health, a hospital in Denver that specializes in allergies and respiratory diseases. Doctors there suspected that his food allergies might not be causing the eczema—and that some might not be food allergies at all. After carefully supervised “food challenges”—giving him tiny amounts and monitoring him closely for signs of a reaction—a number of foods went back in his diet. “We came home with 12 foods he could eat,” says Amy Grebe. “It’s made so much difference in our lives.”

For parents of children with food allergies, this may be both welcome and unsettling news: Many kids whose allergies were diagnosed on the basis of blood or skin tests alone may not be truly allergic to those foods, experts say.

Blood tests measure the level of antibodies, called immunogloblin E (IgE), a body makes to a particular food. But having IgE antibodies doesn’t mean that a person will actually have an allergic symptom when they encounter it.

Skin-prick tests are slightly more predictive, but there, too, a red wheal in response to a skin prick doesn’t necessarily mean that a child will have an actual allergic reaction to that food.

The only way to know for sure—short of encountering the food in real life—is with a food challenge test in a doctor’s office or hospital. But those can be time consuming, expensive and nerve wracking, especially for parents who have seen a child encounter an anaphylactic shock, a life-threatening reaction in which multiple organs quickly shut down.

With use of allergy tests booming, more parents are coming away not fully understanding what they mean. That sometimes frustrates allergy experts. “When I first started doing this, my biggest job was convincing families to avoid a food. Now, the biggest job is to get families back on a food,” says Hugh Sampson, a professor of pediatrics in the division of allergy and immunology at Mount Sinai School of Medicine in New York.

Several recent studies have underscored the gap between IgE antibodies and actual allergies. In this month’s Journal of Allergy and Clinical Immunology, researchers in Manchester, England, reported that when 79 children who tested positive for peanut IgE antibodies were given food challenges, 66 of them could eat peanuts safely. At the American Association of Allergy, Asthma and Immunology (AAAI) conference last year, doctors from National Jewish reported that of 125 young patients given food challenges, more than half could tolerate foods they’d been told to avoid.

Confusion over test results has also made it harder to track the true prevalence and growth of the allergies. It’s widely estimated that some 12 million Americans, including four million children, have food or digestive allergies, up 18% from 1997. But that includes food intolerances, which don’t involve the immune system.

A national sampling from 2005-2006, which also included blood tests, found that 9% of U.S. children had a sensitivity to peanuts, 7% to egg; 12% to milk and 5% to shrimp. But experts believe that only about one-tenth of those children will actually have allergic reactions to those foods. Even the true rate of fatal reactions to food allergies is hard to gauge: Estimates range from as low as five to as high as 200 per year.

Experts agree that the most important part of a food-allergy diagnosis is a history: What did the child eat and what kind of reaction did he have? Even if it seems clear-cut, most doctors will also do a blood test or skin-prick test to confirm that the child has antibodies to the suspect food.

“If you come to me and say, ‘My child ate a peanut butter sandwich and within 15 minutes, his lips turned blue, he got hives and threw up,’ that’s enough to tell me the child has a peanut allergy,” says Dr. Sampson. “The more typical history is that they were eating a meal and he had this horrible reaction and they think it’s peanuts. It’s important to do a skin or blood test to make sure.”

Some experts believe it’s not helpful to test for food allergies when there’s no history of problems with those foods. But what often happens is that a child has a bad reaction to one food and the family is anxious to know if they should avoid others, too. Or a parent or a sibling has a food allergy, and a family wants to know if others are at risk. Some doctors will then screen the child with extensive panels of allergy blood tests that may come back showing the child has IgE antibodies to a wide range of foods.

“I see it all the time. A family goes in for one thing and comes back with a laundry list of foods they are supposedly allergic to,” says Jodi Stokes, whose son Kevin has food allergies, and runs a support group for allergic families in Charlotte, N.C. “I tell them to go to a board-certified allergist who knows how to interpret these tests.”

“Are these blood tests being overused? Possibly. Misinterpreted? Absolutely,” says Robert Wood, director of Pediatric Allergy and Immunology at Johns Hopkins Hospital, who is part of a task force writing guidelines for diagnosing and managing food allergies. “A lot of these kids truly have food allergies, just not to all the foods that they are being told they have allergies to.”

In some cases, the blood or skin tests reveal antibodies to a food that the child has already been eating without problems. It’s easy to dismiss those results. It’s harder to know what to make of IgE antibodies to foods a child hasn’t yet tried. Children with eczema, like Grayson Grebe, tend to have IgE antibodies to a large number of foods, and it can be difficult to sort out which really do pose problems.

Allergy experts can make some guesses about the likelihood of a reaction based on test results, and they are starting to establish cutoff thresholds. In a skin-prick test, for example, a wheal smaller than 5 millimeters in diameter indicates a slim chance of a real allergy, says Dr. Sampson; a wheal greater than 10 millimeters is generally a good chance.

In blood tests, some research suggests that IgE antibody levels higher than 7 KUa/L to egg, 15 to milk and 14 to peanut are highly predictive of an allergic reaction. But some people have allergic reactions at lower levels, too.

And none of those tests can predict how severe an allergic reaction might be. A person with a peanut allergy might react with a tingle in the mouth, a case of hives or a full-blown anaphylaxis, depending on many variables, including how much peanut they ingested and in what form.

Complicating diagnoses further is the fact that food allergies are a moving target as children get older. It’s estimated that 80% of children with allergies to milk, eggs, wheat, diary and soy outgrow them, usually by about age 5. But only about 20% of those with allergies to peanuts, tree nuts and shellfish do. And for reasons not fully understood, some people can develop allergies later in life to foods they’ve previously tolerated, particularly shellfish.

Doctors can get some clues to an allergy’s progression by monitoring skin and/or blood tests regularly. And when IgE levels have been dropping consistently, or were never high to begin with, some may suggest trying a food challenge, usually done in a hospital or specially equipped doctor’s office, where help is immediately available in case of a bad reaction.

The Food Challenge

For some families, deliberately exposing a child to food they have scrupulously avoided for years is simply not worth the risk. But for those who have had to severely restrict a child’s diet, restoring some food groups can be life-changing.

“There is a kind of post-traumatic stress syndrome that happens after a bad allergic reaction,” says Dan Atkins, head of outpatient pediatrics at National Jewish Health. “But the payoff in successful food challenge is huge.”

“I thought it was pretty entertaining,” says 15-year-old Alex Simko of Geneva, Ill., who did a four-hour food challenge with hard-boiled eggs last year after avoiding them for 12 years. She made faces throughout because she hated the taste of eggs. But she didn’t have an allergic reaction—and allowing eggs into her diet has opened up a world of baked goods (“doughnuts!”) she previously had to avoid.

Some other kids aren’t as sanguine. Having been told all his life to avoid eggs all his life, 4-year old Kevin Stokes refused to try them during a food challenge at Duke University Medical Center last year. “He freaked out,” says Jodi Stokes, who holds out hope that he will try again. In the meantime, he is still allergic to peanuts, tree nuts and milk, so they have the same rule that many allergy families have about scrutinizing food labels: “If you can’t read it, you can’t eat it.”

A new kind of blood test could someday help doctors zero in more definitively on who is most likely to have allergic reaction to foods. Phadia AB, a maker of allergy tests, has developed a test, called Component-Resolved Diagnostis (CRD) that can determine which molecule within a food is sparking the antibody reaction. In the peanut, for example, only three of 14 different molecules are associated with anaphylaxis-causing reaction, according to the company. CRD has not yet been submitted for approval by the Food and Drug Administration, but it is in use in Europe.

In the Manchester study, for example, the researchers found that almost all of the children who were highly allergic to peanuts reacted to a specific protein call Ara h 2.

Knowing more about what specific molecules cause allergic reactions could help scientists understand more about the severity of allergic reactions, and someday help efforts to develop treatments to trick the immune system into behaving differently. In the meantime, parents with allergic children are often left walking a fine line, between taking potential life-threatening risks seriously, and not overreacting to tests that may not reflect a child’s actual risk.

As the world braces for the 2009-2010 flu season, the Centers for Disease Control and Prevention’s (CDC) advice is loud and clear: Get vaccinated. This year’s flu season is fully expected to bring another surge of the novel H1N1 or “swine flu” virus, in addition to the other forms of the seasonal flu. While the CDC has advised everyone to be vaccinated, people with asthma are in the top five priority target groups. Because asthma, seasonal flu and swine flu are respiratory conditions, the viruses can trigger more frequent and severe asthma attacks, resulting in a more severe case and longer recovery.

Pregnant women, young children 6 months to 4 years of age, children ages 5 to 18 who have chronic medical conditions, those who care for children younger than 6 months of age and health care workers with direct patient contact have been identified as those who should receive the vaccine first if it is in limited supply.

While H1N1 never disappeared entirely, the number of cases in the United States dropped as expected during the summer months. However, the anticipated increase in the 2009-2010 fall and winter seasons started unusually early this year, with widespread flu activity already reported in several states as early as August.

If you have asthma and the H1N1 vaccination is not available when you first seek it, the CDC recommends that you get the seasonal flu vaccine and return to your health care provider or a public health clinic to request the H1N1 vaccination. Local news reports and your public health department also may help you determine the availability of the vaccine in your area.

The seasonal flu vaccine can be given separately or on the same day as the H1N1 vaccine. In addition to the vaccine, mom’s advice also applies here: Frequent hand washing (with soap and water or alcohol-based hand cleaners) and covering your mouth when you cough or sneeze are two of the best ways to stay healthy and prevent the spread of flu. Other preventive tips from the CDC:

• Stay home when you have the flu to prevent spreading it to others.
• Keep your distance from those who are sick.
• Avoid touching your eyes, nose or mouth, which are the most common ways to spread germs.
• Take care of yourself: Get plenty of sleep each night, drink lots of fluids, eat nutritious foods, stay active and reduce stress.

Time Magazine article

New York Times article

The CBS Evening News (12/18, story 12, 2:15, Couric) reported, “For generations, mothers…have doled out” their “own brand of medical advice,” such as keeping children “bundled under hats in the winter, and away from sugar.”

But, the Canadian Press (12/18) reported that many “commonly held beliefs are untrue,” according to research published in the Christmas issue of the BMJ by “myth busters extraordinaire Rachel Vreeman, M.D., and Aaron Carroll, M.D.,” of the Indiana University School of Medicine. For instance, the authors analyzed “data from 22,793 calls about poinsettia ingestion made to US poison control centers,” and “found no deaths, and no one who really even needed medical care.” Thus, they dispelled the myth that poinsettias are poisonous.

CNN (12/18, MacMillan) reported that, according to the authors, “a 35-year study on Minnesota residents found that suicides did not increase on or around Christmas, or any other major holidays, including birthdays, Thanksgiving, or the Fourth of July.” In fact, “research from all over the world…shows that suicides are actually more prevalent in warm, summer months — a pattern that scientists can’t quite explain.” Therefore, “while suicidal thoughts should be taken seriously at any time of year, there’s no reason to think that this month is especially dangerous,” they concluded.

The researchers also sought to determine if eating at night makes people fat, MSNBC (12/19, Runevitch) adds. The investigators found “nothing worse about a nighttime snack than a morning snack.”

Drs. Vreeman and Carroll also showed that “there is nothing special about heat loss from the head — any uncovered part of the body would lose heat,” BBC News (12/18) noted on its website.

Finally, HealthDay (12/18, Gordon) pointed out that the authors discussed “at least 12″ studies which “have looked at the effect of sugar on children, and none found evidence for the sugar-equals-hyperactivity myth.” US News and World Report (12/18) also covered the story, as did CBS News (12/18) on its website.

• The holidays are filled with hustle and bustle, but stress can trigger an asthma attack. Shop early or late in the day to avoid crowds. If “quiet time” isn’t a part of your normal routine, now is the time to start. Practice deep breathing and relaxation techniques to calm your nerves.
• Fires burning in the hearth bring warmth and ambiance to a holiday get-together. However, the smoke and ash can smother the spirit for some, provoking breathing difficulties or triggering an asthma attack. Request the Yule log remain unlit.
• Prepare for visits to homes with pets by taking your allergy or asthma medication before the visit. The medication may help reduce your reaction. You can also ask party hosts to keep Fido in a separate room.
• Food is a central fixture in most holiday gatherings. Remember that homemade items don’t come with ingredients lists. If you or your child has food allergies, be cautious, especially around homemade treats. Foods can become tainted through cross-contamination in the baker’s kitchen or food storage containers – and even a trace amount can trigger a reaction.

Use the links below for additional patient resources on allergies and asthma, including allergy friendly holiday recipes.

Additional Resources

• Allergy-free holiday recipes
• Tips to Remember: Traveling with asthma and allergies
• Tips to Remember: Indoor Allergens

On Halloween, parents of food-allergic children must be extra vigilant to ensure their child is not at risk of a reaction. The AAAAI (our national allergy society) offers these tips for creating a safe Halloween for food-allergic children:

• Accompany younger children as they trick-or-treat and send older children out with a group of friends. Don’t allow your child to trick-or-treat alone.
• Verify that adults or friends with your child understand his food allergies and what to do in an emergency.
• Make sure your child carries emergency medication along on Halloween night.
• Before Halloween, distribute safe snacks to neighbors and request that they be handed out to your child.
• Eat dinner before trick-or-treating to reduce urges to sneak a treat.
• Remember that small candy bars passed out to trick-or-treaters may have different ingredients than their regular-size counterparts. Even if a certain candy is safe for your child, the ‘fun size’ version might not be.
• Carefully check all treats’ ingredients on packages or company Web sites to ensure there is no risk for a reaction.
• If in doubt about ingredients, throw the candy away.
• Work with your child’s teacher to plan a school party involving non-food treats, such as stickers or novelty erasers. Or, pack treats from home that other students can give to your child.
• Instead of trick-or-treating, host a party that focuses on costumes, pumpkin carving, games and other Halloween-themed fun.
• Create a “candy swap” with siblings or friends so that allergen-containing candies can be traded for other, safe, treats.
• Teach your child to politely refuse offers of home-baked goodies like cookies or cupcakes.
• Consider participating in a charity trick-or-treat event to raise money for a good cause, rather than collect candy. The Food Allergy & Anaphylaxis Network hosts an annual drive to raise money for food allergy education and research. Visit www.foodallergy.org for more information.

The AAAAI offers additional food allergy resources online at www.aaaai.org.

Who should get the flu vaccine?

Most people who want to reduce the risk of getting influenza can get a flu shot. The CDC recommends the flu vaccine each year if you:

• Are age 6 months up to 19 years
• Are pregnant
• Are 50 years old or older
• Have a chronic medical condition such as asthma, diabetes, or heart, kidney or lung disease
• Have a weakened immune system such as from medications or HIV infection
• Are a resident of a nursing home or other long term care facility
• Are a child care worker or health care worker or live with or care for someone at high risk of complications from the flu

Who shouldn’t get the flu shot?

Don’t get a flu shot if you:

• Have had an allergic reaction to the vaccine in the past.
• Are allergic to eggs (consult with your allergist).
• Developed Guillain-Barre syndrome, a serious autoimmune disease affecting the nerves outside the brain and spinal cord, within six weeks of receiving the vaccine in the past. People who have experienced Guillain-Barre after the flu vaccine are at higher risk than are others of developing it again.
• Have a fever. Wait until your symptoms improve before getting vaccinated.

More information…

• Please call Mid Island Allergy Group to check for availability of flu vaccine.
• We currently carry Fluvirin; an inactivated form of the flu vaccine indicated for ages 4 years and up.
• For more information click here for the CDC link.