FDA Orders Unapproved Cold Drugs Off the Market.

FDA orders unapproved cold drugs off the market.
The CBS Evening News (3/2, story 7, 0:30, Couric) reported, "In health news, the FDA today ordered about 500 prescription drugs used for treating colds, coughs, and allergies removed from the market. The reason, the drugs contain ingredients that have not been approved by federal regulators."
The Washington Post (3/3, Stein) reports, "Federal health officials Wednesday announced a crackdown on the sale of prescription cold, cough and allergy products that had never been proved to be safe and effective. About 500 products that had not been formally evaluated by federal regulators will be removed from the market," the FDA announced. The move is the latest in "a series of actions by the agency to stop the sale of a variety of products that were being sold without government authorization." Deborah Autor, director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research, said that because the products had not been approved, the agency was uncertain if they were safe or effective, adding, "And we believe that poses an untenable risk to consumers."
The Los Angeles Times (3/3, Zajac) notes that although the drugs "have been linked to a few relatively minor problems, such as drowsiness and irritability," the FDA is concerned that "medical problems associated them may be significantly underreported." The AP (3/3) adds that some of the "drugs combine two varieties of the same ingredient, such as the allergy-reliever antihistamine."
The New York Times (3/2, Pollack) "Prescriptions" blog reported, "Agency officials said they did not know how many patients were taking the drugs that would be removed from the market. But popular over-the-counter cold medications, which are used more frequently than prescription drugs, are not affected by FDA's order."
Meanwhile, the National Journal (3/3, Fox, subscription required) reports, "Dr. Richard Irwin, chair of the American College of Chest Physicians' cough guidelines and a professor of medicine and nursing at the University of Massachusetts, said the older prescription cold drugs are being used more commonly because of several other federal enforcement actions." Dr. Irwin said, "I think they are prescribed very commonly. ... A few years ago, most of the prescription antihistamine/decongestant medications that were available suddenly became unavailable."
CQ HealthBeat (3/3, Adams, subscription required) points out that the "withdrawals mark the 17th time that the agency has taken action against unapproved medicine since the Bush administration started an initiative in 2006 to examine these types of drugs." The Wall Street Journal (3/3, Rockoff, Dooren, subscription required), the CNN (3/3, Young) "The Chart" blog, the Time (3/2, Park) "Healthland" blog, HealthDay (3/2, Reinberg), and Medscape (3/2, Hitt) also cover the FDA order.