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FDA bans hundreds of unapproved allergy, cold, and cough products

Posted Mar 04 2011 3:44pm

Consumer Reports Health Blog

When you get a prescription drug from your doctor you probably assume the product has been approved by the U.S. Food and Drug Administration. But that’s not always the case. On Wednesday the FDA banned hundreds of products it never officially approved, as part of an ongoing effort to clean up the market place of products that were introduced before newer, stricter standards were established. This time around, the agency is focusing on unapproved allergy, cold, and cough products.

The products aren’t being banned because the active ingredients in themsuch as the cough suppressant dextromethorphan, the decongestant phenylephrine, and the expectorant guaifenesinare unapproved, but because the manufacturers of certain specific products haven’t provided the FDA with the necessary evidence to prove that their versions are safe and effective. The unapproved products made it onto the market in the first place because they were introduced before FDA regulations, established in 1962, required all new products to provide that documentation.

The FDA worries that some of the unapproved products may be inappropriately labeled for use in infants and children, manufactured incorrectly, have potentially risky combinations of ingredients, or pose other risks. The FDA ordered that manufacturers stop making and distributing some of the drugs immediately; others will have up to six months to phase out their distribution.

Click here to read the rest of this report on the Consumer Reports Health log and to find a searchable database of approved and unapproved drugs

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