Prescriptions - Making Sense of the Health Care Debate
March 2, 2011, 11:49 am
F.D.A. Orders Prescription Cold Drugs Pulled From Market
By ANDREW POLLACK

The Food and Drug Administration on Wednesday ordered the removal from the market of more than 500 prescription drugs used to treat colds, coughs and allergies because the medications had never gone through a federal review of their safety and effectiveness.

“We don’t know what’s in them, whether they work properly or how they are made,’’ Deborah Autor, the director of the office of compliance in the F.D.A.’s drug division, said in a telephone news conference on Wednesday morning.

But Ms. Autor said the agency did not believe the action would have a significant impact on patients and doctors because there were plenty of cold and allergy medicines available that have received F.D.A. approval. F.D.A. officials said they did not know how many patients were taking the drugs that would be removed from the market.

But most patients are believed to use over-the-counter cold medications, rather than prescription drugs, and none of those are affected by Wednesday’s action.

In 2008, the F.D.A. issued an advisory that over-the-counter cold medicines should not be used by children under 2 years of age because they could have dangerous side effects and there was little evidence they worked.

Since then, agency officials said, many manufacturers of such drugs have relabeled their products to advise that they are not to be used by children under 4. F.D.A. officials said on Wednesday that they believed the over-the-counter cold and allergy remedies that remain on the shelves were safe if used as directed.

The action on cold medicines is the latest in a campaign by the F.D.A. to remove unapproved drugs from the market. Many have been marketed since before the 1962 federal law that required drugs to undergo agency review for safety and effectiveness. The F.D.A. said many physicians were unaware that they were prescribing drugs that had never been approved.

Since 2006 the agency has removed 16 other classes of unapproved drugs from the market. But the cold, cough and allergy class is the largest action by far in terms of the number of drugs covered.

The drugs include Cardec, Lodrane, Organidin and Pediahist. Some 27 different ingredients are covered by the drugs on the list. Most of the products are believed to be made in the United States, the officials said.

The agency has posted further information, including a list of the drugs covered, on its Web site.

F.D.A. officials said they became concerned because some of the ingredients were the same as those in the over-the-counter drugs that posed potential risks for young children. And some of the prescription drugs on the list were being prescribed to children as young as 1 month old.

The agency said there had been some reports of problems from the drugs, such as drowsiness, sedation and irritability, but data were not complete.

The F.D.A. tested six of the drugs that were extended-release products, meaning they were supposed to release their active ingredients gradually over eight to 12 hours. Three of them released 85 percent of its ingredients in only 30 minutes, Ms. Autor said. Another released only 25 percent of its active ingredients over the entire time period.

The manufacturers of the listed drugs have 90 days to stop manufacturing and 180 days to stop distribution.

    * Copyright 2011 The New York Times Company
    * Privacy Policy
    * NYTimes.com 620 Eighth Avenue New York, NY 10018