Why All The Drug Alerts?

By Francesca Lunzer Kritz
Special to The Washington Post
Tuesday, February 26, 2008

If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has. Since early November, the agency has sent out 14 advisories, more than it has issued in some entire years. Wall Street health-care analyst Les Funtleyder recently quipped that the agency should have a color coding system, as the Department of Homeland Security does, so consumers could determine the severity of the risk.

The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.

"We are trying to act in a responsible way," Seligman says.

FDA critics, including Rep. John Dingell (D-Mich.), head of the House Energy and Commerce Committee, have complained that the agency's responses are too few and too late. As a case in point, they cite the recall of the pain reliever Vioxx four years ago. Some critics said the FDA had long known of concerns about Vioxx and delayed taking any action on the drug, including requesting that the company add information on heart disease risk to the label.

Dingell calls the recent increase in public communications "a quantum improvement." Marc J. Scheineson, a former FDA deputy commissioner, agrees. "There was certainly too little information back then,'' he says. Now, the problem is the opposite, he says, "so patients and their doctors will need to filter the news.''

Since the fall, the agency has begun issuing three new types of advisories: an "early communication" that indicates a recently reported problem with a drug; a "public health advisory" that advises consumers to speak with their doctors because a drug may pose a serious risk; and a Q and A for physicians to help them answer patient questions.

In November, an early communication advised that patients on Chantix, a smoking-cessation drug, had reported side effects including depression and suicidal behavior. Two months later, a public health advisory noted that drugmaker Pfizer would add safety warnings to its label, at the agency's request. The FDA also issued a fact sheet for doctors, identifying factors (such as a history of psychiatric illness) that would make someone a poor candidate for Chantix and listing symptoms that users should report promptly.

Some advisories hold good news for patients, Scheineson says. He cites a December advisory that found no link between two acid reflux drugs and heart problems -- a concern previously reported.

"That shows the system is working'' says the FDA's Seligman.

While the advisories are meant primarily for physicians, consumers have easy access to them: on the FDA Web site ( http://www.fda.gov), via e-mail alerts ( http://www.fda.gov/emaillist.html) and in a new quarterly newsletter ( http://www.fda.gov/cder/dsn/default.htm).

Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.

No patient should stop taking prescribed medication without first consulting his or her doctor, warns Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed," Platt says. Advice on whether to continue a cited drug will vary by patient.

The FDA is also working with medical oganizations to help physicians understand the nuances of its advisories and pass along that information to patients. For example, the agency is sending weekly e-mails to members of the American Medical Association, said Edward Langston, who chairs the AMA's board of trustees.

Francesca Lunzer Kritz is a frequent contributor to Health. Comments:health@washpost.com.

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