Infants' cold medications pulled from market due to potential health risks

WASHINGTON -- Drug makers on Thursday voluntarily pulled children's cold medicines off the market less than two weeks after the government warned of potential health risks to infants.

Over-the-counter medications aimed at children younger than 2 are being removed from store shelves because of rare instances of parents overdosing young children, a trade group that represents the drugs' manufacturers said. The group said parents should no longer administer these medications.

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Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic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.

Catherine Tom-Revzon, a pediatric pharmacist, said parents should use natural therapies, including saltwater drops and humidifiers, to treat infants' colds before using drugs.

"These medications were never designed to cure colds but only to treat cold symptoms, and in children under 2 there was little evidence they were effective anyway," said Tom-Revzon, who is pharmacy manager at the Children's Hospital at Montefiore in New York.

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.

The medicines come in tiny, droplet-size doses, but parents occasionally do not consult or follow directions from physicians, which can lead to accidental overdose.

FDA will formally consider revising labeling at a meeting scheduled for Oct. 18 and 19.

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 manufacturers made this decision after a lot of consideration and with great care for the best interests of parents and children," said CHPA spokeswoman Virginia Cox. "But we can't speak to what the future holds."

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.

FDA is reviewing the safety of cold medicines at the request Sharfstein and other Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.

Shares of Johnson and Johnson rose 28 cents to $66.012 while shares of Wyeth fell 12 cents to $46.02. Shares of Novartis AG rose 11 cents to $54.20 and Prestige Brands Holdings Inc. fell 7 cents to $11.09.