FDA recalls about 500 medicines: Which made list, and why?
(CBS/AP) The FDA is giving the cold shoulder to some cold and allergy medications. On Wednesday the agency said it would pull from the market about 500 unapproved cold and allergy drugs as part of an ongoing crackdown on ineffective prescription drugs.
The FDA requires drug makers to submit all new prescription drugs for scientific review before they are launched. But thousands of drugs 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 drugs cited by the FDA represent a small portion of the market.
FDA's action does not affect any over-the-counter products.
"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."
Among the drugs listed by the FDA is 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.
Many of the older drugs cited by the FDA are manufactured by multiple companies, often using different ingredients and dosages. For instance, a dozen companies market a drug called Rondec, according to the FDA website.
"That's what makes them so dangerous: they have these shared names but different ingredients and different doses, so it's very easy for medication errors to occur," said Patti Gasdek Manolakis, a pharmacist and consultant who has researched unapproved drugs in the U.S.