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Infant cold medications pulled from market amid safety concerns

Parents urged to stop use

WASHINGTON — Some of the nation's largest drug makers will no longer sell cold medicines targeted at infants due to safety concerns.

Thursday's voluntary decision by Johnson and Johnson, Wyeth and other drug makers to pull their products off the market comes two weeks after government health officials said parents should not give the over-the-counter medicines to children younger than two.

Although many of the products come in drop-size doses designed for youngsters, a trade group for the medicine makers said there have been rare instances of parents accidentally overdosing young children. The group said parents should not use any medicines they have at home in infants.

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Cold medicines being withdrawn include infant versions of Johnson & Johnson's Pediacare and Tylenol drops, Wyeth's Dimetapp drops, Novartis' Triaminic strips and Prestige Brands Holdings' Little Colds Decongestant.

The move is not expected to have a major impact on industry bottom lines, as most of the companies affected rely more on prescription drug sales. Johnson and Johnson's over-the-counter medicine segment accounted for just 5 percent of total sales last year. Wyeth's entire consumer health division, which includes everything from vitamins to asthma inhalers, accounted for just 12 percent of sales.

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 two 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.

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

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 12 cents to close at $65.95 while shares of Wyeth rose 13 cents in after-hours trading to $45.91 and ended the regular trading session down 38 cents to $45.78. Shares of Novartis AG rose 15 cents to $54.08 in after-hours trading and ended the day down 15 cents at $53.93 and Prestige Brands Holdings Inc. fell 4 cents to $11.09 in after-hours trading and closed down 3 cents at $11.13.