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FDA cracks down on untested cold medicines

FDA cracks down on untested cold medicines

March 3rd, 2011 in News

WASHINGTON (AP) - The Food and Drug Administration said Wednesday that it will remove roughly 500 unapproved cold and allergy medications from the market as part of an ongoing crackdown on ineffective prescription drugs.

The FDA requires companies to submit all new prescription drugs for scientific review before they are launched. However, thousands of drugs actually predate the FDA's drug regulations and have escaped scrutiny for decades.

Most of the drugs targeted by the latest action are pills using untested combinations of decongestant and cough-suppressing ingredients. Since most Americans buy their cold medicines over the counter, the prescription medicines cited by the FDA represent a small portion of the market. FDA's action does not affect any products sold over the counter.

"We don't expect today's action to have a negative impact on consumers," said Deborah Autor, director of the FDA's Office of Compliance. "There are multiple other products available to treat cold, cough and allergy symptoms."

The agency said manufactures who have not registered their products with the agency must halt production and shipments immediately.

Among the drugs listed by the FDA are products like Pediahist, a cold formula labeled for patients as young as one month old. FDA regulations do not recommend cold medicines for any children under age 2.

Other drugs combine two varieties of the same ingredient, such as the allergy-reliever antihistamine. Regulators called such combinations "irrational," and warned that they could cause excessive drowsiness.