updated 3/2/2011 12:06:39 PM ET 2011-03-02T17:06:39

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

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

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.

"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.

Story: Zinc really can ease your cold, study finds

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.

Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments

Advertisement