Friday, October 19, 2007

Children Under age 6 at risk over counter cold medication

Doctors press FDA on safety of cold medicines for children under 6
October 18, 2007



WASHINGTON — Cold and cough medicines recently pulled from sale for infants and toddlers shouldn’t be given to children as old as 5, either, pediatricians told government health advisers Thursday.

The expert advisers to the Food and Drug Administration began a two-day meeting to consider a petition from the pediatricians that seeks in part a government statement saying the over-the-counter medicines shouldn’t be used in children under 6 because they don’t help them and aren’t safe.

The FDA has yet to act on the petition, in part pending a recommendation expected late Friday from the joint panel of outside experts in pediatrics and nonprescription drugs, said the agency’s Dr. Joel Schiffenbauer.

The meeting opens a week after drugmakers pulled from sale oral cough and cold medicines for children under 2. The drug industry maintains the widely used medicines are safe and work but can lead to overdoses when misused in infants.

However the petitioners, including Baltimore city health officials, argue that the medicines not only don’t work in children up to age 6 but that they can be dangerous as well.

While the medicines have been marketed for use in children for decades — ad spending now is roughly $50 million a year — it has long been acknowledged there is negligible or no data from studies in the very young to show they are safe and work. Worse, some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

“When a treatment is ineffective, its risks — if not zero — always will exceed its benefits,” said Dr. Michael Shannon, a Children’s Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.

The drugs — including some Dimetapp, Pediacare, Robitussin and Triaminic products — have never been tested in children, which a previous FDA panel noted as long ago as 1972. Drugmakers instead have used extrapolated data from studies in adults to come up with dosing recommendations based on a child’s age or size.

While the focus of the petition and the FDA is on children under 6, the joint panel of experts will be asked if there’s evidence that these drugs work in children up to age 12.

The medicines are widely used, with an estimated 95 million packages sold for infant and toddler use each year.

“If these medicines are allegedly not effective or materially unsafe, how is the purchase of millions — hundreds of millions — of doses by parents explained?” asked Dr. George Goldstein, the panel’s nonvoting industry representative.

Cough and Cold Medication WarningsPosted Oct-11-07 07:35:16 PDTThe FDA has issued a public health advisory instructing parents not to give Over The Counter cough and cold remedies to children younger than age 2. This warning expands on concerns voiced earlier this year that anithistamine-decongestant cough suppressant medication is unsafe for young children.

Three key ingredients common to prescription and Over the Counter Cough and Cold remedies have been linked to infant deaths. Psudoephedrine, dextromethorphan, and carbinoxamine-containing Cough and Cold Medicines should never be used for children under 2. The safety of these medications is being investigated for use with children under age 6 as well.


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