FDA cracks down on untested cold medicines

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.

Doctors may not realize they are prescribing unapproved drugs because the products are often labeled just like FDA-approved products, according to the agency.

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, 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.

It wasn’t until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were supposed to be evaluated over time. But some manufacturers claimed their medications were grandfathered under earlier laws.

The FDA began its latest crackdown on unapproved drugs in 2006 and has taken action against 17 types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars’ worth of medications. But federal law does not call for fines for selling unapproved drugs, and criminal prosecutions are rare.