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Children’s Cold Medicines Pulled Due To Health Risks

The Associated Press reports today that several manufacturers have pulled children’s cold medicines off the shelves after a recent government warning of potential health risks to infants. Excerpts:

Over-the-counter medications aimed at children under the age of two are being removed from store shelves because of rare instances of parents accidentally overdosing young children, a trade group that represents over-the-counter drug makers said. The group said parents should not use any medicines they have at home.

The Consumer Healthcare Products Association said last month it agreed with government officials that use of the drugs should be restricted, but had previously stopped short of pulling the products from the market.

Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth’ s Dimetapp Decongestant Infant Drops, Novartis’ Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings’ Little Colds Decongestant Plus Cough.

CVS Caremark Corp. said Thursday morning it would remove the affected products as well as CVS-brand equivalents from store shelves. The pharmacy chain said customers can return the products for a full refund.

Late last month the Food and Drug Administration tentatively recommended adding the words “do not use in children under two years” to products’ labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers.

After reviewing reports of side effects over the last four decades, FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children’s deaths connected with antihistamines, which are used to treat runny noses.

The Consumer Healthcare Products Association said it will conduct a multiyear campaign to educate parents and physicians on safe use of cold medicines. A spokeswoman for the group said it was too early to rule out a return of the products to the market.

The trade group stressed in a statement that the “medicines are, and have always been, safe at recommended doses.”

However, industry critics challenged this statement.

“When it comes to children under age two there are no recommended doses on these products so it’s not reasonable to claim they are safe and effective when used as directed,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner.

Catherine Tom-Revzon, a pediatric pharmacist, said parents should use natural therapies, including salt-water drops and humidifiers, to treat young children’s colds before using drugs.

“These medications were never designed to cure colds but only to treat cold symptoms, and in children under two there was little evidence they were effective anyway,” said Tom-Revzon, who is pharmacy manager at the Children’s Hospital at Mentefiore in New York City.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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