posted October 13, 2007 01:11 PM         

Infant Cold Medications Pulled From Drugstores

By Rob Stein
Washington Post Staff Writer
Friday, October 12, 2007; Page A01

Drugstores began clearing their shelves of over-the-counter cough and cold medicine designed for infants yesterday after leading manufacturers announced they were withdrawing the products amid rising concerns about the safety of the popular remedies.

The decision to pull 14 products, including well-known brands such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold and Robitussin Infant Cough DM Drops, came one week before the Food and Drug Administration plans to hold a hearing on nonprescription cough and cold medications for children.

The hearing is part of a broad evaluation of the products the agency launched in light of doubts about their effectiveness and mounting evidence the medications can cause serious complications, including severe hallucinations and agitation, seizures, high blood pressure, and heart and breathing problems that can be fatal in rare cases.

The companies maintain that the products are safe and effective when used properly but said they acted because of the risk of complications when misused, with most complications apparently occurring in children younger than 2.

"These medicines are -- and always have been -- safe at the recommended doses," said Linda A. Suydam, president of the Consumer Healthcare Products Association, the industry group that announced the withdrawal. "These voluntary actions are being taken out of an abundance of caution."

The companies withdrawing the products -- McNeil Consumer Healthcare, Novartis Consumer Health and Wyeth -- represent at least 95 percent of the market, the association said.

Critics of the products welcomed the move but called for the FDA to take further action, saying the products pose a hazard even when used at the proper doses.

"Today's action is an important step in the right direction, but FDA must do more to protect children," said Joshua M. Sharfstein, Baltimore's health commissioner, who led a petition to the FDA after four children died in Baltimore after taking the medications. "Clearly, the products don't work and are unsafe."

Sharfstein said the FDA should institute a formal ban on the products for children age 2 and younger to make sure no other companies begin offering them.

"You don't want another manufacturer coming along and saying, 'Hey, this looks like a good market for me,' " he said.

In addition, Sharfstein said the agency should strengthen warning labels on the dozens of products still on the market that advise against their use in children younger than 6, and bar packaging that includes terms such as "toddler" that might encourage parents to use the medications in children that young.

"There is no evidence that the products are effective for young children, and there is evidence they can be unsafe, even at the usual doses. This is not just about misuse," he said, noting that the dosages typically used are untested estimates based on studies in adults. "That's why we are asking FDA to clearly label these products against use by children under age 6."