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FDA Removing Unapproved Cold And Allergy Drugs From Market

March 2, 2011

The Food and Drug Administration (FDA) said on Wednesday that it will remove about 500 unapproved cold and allergy medications from the market If 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 are pills using untested combinations of decongestant and cough-suppressing ingredients.  The prescription medicines cited by the FDA represent a small portion of the market, since most Americans buy their cold medicines over the counter.

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

The FDA said manufacturers who have not registered their products with the agency must stop production and shipments immediately.

Pediahist, a cold formula labeled for patients as young as one month old, is among the drugs listed by the FDA.  FDA regulations do not recommend cold medicines for children under the age of 2.

Other drugs combine two varieties of the same ingredient, like the allergy-reliever antihistamine.  Regulators called these combinations “irrational,” and warned they could cause excessive drowsiness.

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

It was not 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.  However, some manufacturers claimed their medications were grandfathered under earlier laws.

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

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