• Defective Drug Side Effects

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A government advisory panel recommended a ban on cough and cold medicines for children under the age of 6. In its decision, the panel stated that the drugs have not been proven safe and effective and in some cases may even be harmful.

More than a dozen infant cough and cold products were pulled from store shelves just over a week ago, but it may take longer for a total ban to take effect. Currently there are approximately 800 pediatric cough and cold medicines on the market in the U.S.

The FDA & Panel Recommendations

The Food and Drug Administration is not bound to panel recommendations, though it usually follows them. However, in cases where the panel vote is close, the FDA may not heed the advice.

Last Friday, the panel voted unanimously that over-the-counter cold medicines should be banned for children under 2 years old. For children between 2 and 5, the vote was much closer — 13 to 9.

Even if the FDA wants to ban the medications, it may run into some difficulty since its regulatory powers are somewhat limited with regard to over-the-counter medications, particularly those that are already “generally recognized as safe and effective.”

“You may all vote that they should go away today but under administrative procedures that may not happen,” said FDA non-prescription drug official, Dr. Charles J. Ganley.

Manufacturer Claims

Manufacturers argue that their products are safe and effective and many even market their products as “doctor recommended,” a claim the panel said was outrageous since most groups that represent pediatricians do not recommend the drugs for children.

“In my pediatric cardiology practice, we uniformly suggest that patients avoid these medications,” said Dr. Geoffrey I. Rosenthal, a pediatric cardiologist and panel member, adding that these medicines can be especially dangerous in children with undiagnosed heart conditions.

New Studies Needed

Cough and cold medicines for children have been on the market since the 1970s when clinical trial standards were different and the drug approval process was less stringent than it is today.

Panel advisors said these drugs need to be studied further before given to children in light of growing reports of their possible harmful effects. The panel also cited an increasing body of research showing that the medicines are no more effective than placebos in improving children’s cold symptoms.

(Source: New York Times online)

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