WASHINGTON — 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 medicines 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. Because most Americans buy their cold medicines over the counter, the prescription medicines cited by the FDA represent a small portion of the market.
“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.
Among the drugs listed by the FDA are products such as Pediahist, a cold formula labeled for patients as young as 1 month old. FDA regulations do not recommend cold medicines for children under age 2.
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’s website. “That’s what makes them so dangerous: They have these shared names but different ingredients and different doses,” said pharmacist Patti Gasdek Manolakis.
