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FDA Orders Unapproved Cold Drugs Off The Market

A story about the Food and Drug Administration pulling hundreds of cold and cough medicines from the market garnered extensive print media coverage, but only one network television station mentioned it. Many of the sources indicated that this action would have minimal or no impact on most consumers. 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 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 Food and Drug Administration announced.” The Post explains that this “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 Wall Street Journal also quotes Autor as saying, “Removing these unapproved products from the market will reduce potential risks to consumers.”

The Los Angeles Times reports, “The drugs have been linked to a few relatively minor problems, such as drowsiness and irritability, but the FDA is concerned that medical problems associated them may be significantly underreported.” For instance, “some of the targeted drugs are labeled as suitable for infants and children but contain ingredients covered by a 2008 FDA advisory that warned against using over-the-counter medications in children under age 2.” Meanwhile, “others are billed as timed-release products,” which can be “difficult to manufacture and, if quality controls are inadequate, some may release drugs too slowly, too quickly or not at all, Autor said.”

The AP reports that some of the “drugs combine two varieties of the same ingredient, such as the allergy-reliever antihistamine.” Regulators warned that this “could cause excessive drowsiness.” Notably, “since most Americans buy their cold medicines over the counter, the prescription medicines cited by the FDA represent a small portion of the market.” Autor commented, “We don’t expect today’s action to have a negative impact on consumers.”

The New York Times “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.” The Times added that “Dr. Richard S. Irwin, an expert on coughs at the University of Massachusetts and editor in chief of the journal Chest,” was in agreement with “the FDA’s action,” although he pointed out, “I wasn’t actually aware, and I don’t think many physicians were aware, that you can prescribe a drug that isn’t approved.”

Meanwhile, the National Journal 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.” 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 reports, “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 Most of the them went on the market decades ago.”

The CNN “The Chart” blog reports that all of the affected medicines “are made in the US, and many of these drugs have been on the market for years, before a 1962 law that required products be proved safe and effective before getting approval. Despite that law, many remained on the market illegally.”

The Washington DC Examiner reports, “Consumers who believe they have an unapproved cough, cold, or allergy product should contact their healthcare provider to discuss alternative treatment. Adverse events should be reported to healthcare providers as well.

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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