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OTC Cold Medicines for Infants are Dangerous, Don't Work Says FDA Study

Oct 2, 2007 | Parker Waichman LLP Over-the-counter (OTC) cold medicines don’t work for very young children, and they could very well be dangerous.   That is the conclusion of a group of Food & Drug Administration (FDA) experts tasked with reviewing the safety and effectiveness of OTC decongestants and antihistamines marketed for use in children under 2.   Their report went even further, urging the FDA to consider a total ban on these defective drugs.

According to the FDA, there are about 800 different OTC cold medications sold in the US that are marketed for use in young children.  Amazingly, the FDA had never previously studied the safety or effectiveness of these products in children.  Years ago, the agency had concluded that if OTC cold preparations were safe and effective for adults, then smaller doses would be safe and effective for children.

Now, evidence is piling up that the FDA was wrong about OTC infant cold remedies.  Earlier this year, research conducted bythe Centers for Disease Control found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common OTC decongestants and antihistamines. The FDA safety reviewers reached similar conclusions.  Their research found that from 1969 to 2006, at least 54 children died after taking OTC decongestants, and 69 died after taking OTC antihistamines.   And the FDA safety reviewers found little to convince them that OTC cold remedies marketed for use in infants did anything to relieve cold symptoms.

The FDA safety reviewers are recommending a ban on all OTC infant cold medications.   They also recommended that the droppers, cups and syringes included with products for children be standardized to reduce the risks of confusion and overdose.

Obviously, the makers of OTC infant cold remedies are against removing these products from the market.  Infant OTC cold medicines represent big business for these companies.   According to one report, Americans spent nearly $2 billions on these drugs in 1990.  The Consumer Healthcare Products Association, a drug industry trade group, commissioned its own safety review of OTC infant cold preparations.  Not surprisingly, the industry-funded review did not recommend removing these products from the market.  But the report did recommend that the FDA add warning labels to OTC medications saying that the products should not be used in children under 2.   But that will likely just confuse many caregivers, as a large number of these products have the word “infant” in their names, and feature pictures of babies on their packages.

The FDA is set to consider the findings of its safety experts later this month.  The agency will convene a panel of outside experts to review the safety of OTC infant cold medicines, and recommend what steps the FDA should take in regard to these products.  In light of the findings of the FDA safety review, it is expected that the advisory panel will recommend that the agency take some type of action toward OTC infant cold remedies.   

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