Drug illustrates approval turmoil
By SARAH AVERY AND CATHERINE CLABBY
Raleigh News & Observer
January 09, 2005

- Charges that the Food and Drug Administration practices lax oversight of drugs have cast new attention on a GlaxoSmithKline asthma treatment that has been flagged for problems in the past.

The drug, Serevent, has been marketed in the United States since 1994 by Glaxo.

In testimony before Congress in November, an FDA official listed Serevent as one of five drugs he thinks is dangerous. His testimony underscored concerns that already had resulted in a warning label on Serevent packaging.

The testimony by the FDA's Dr. David Graham heightened criticism that the agency is too eager to license new drugs and then fails to adequately monitor them for problems once they're in medicine cabinets.

In testimony in November before the Senate Finance Committee, Graham, a reviewer in the FDA's Center for Drug Evaluation and Research, cited GlaxoSmithKline's asthma treatment Serevent among five drugs that need "to be seriously looked at" for safety.

The others he cited are Meridia, a weight-loss drug from Abbott Laboratories; Crestor, an anti-cholesterol drug from Astra Zeneca; Accutane, an acne drug from Roche that has been linked to birth defects, and Bextra, a painkiller from Pfizer that has shown increased risks of cardiovascular events among patients after heart surgery.

That debate sparked again in recent weeks, with news that the arthritis drug Celebrex increases the risk of heart attacks when taken in high dosages.

The case of Serevent is an example for both critics and defenders of the drug approval system. Supporters argue Serevent is safe and was appropriately tested before and after it went to market. Detractors say it poses a danger and note that other available asthma drugs don't carry Serevent's risks.

For consumers, the lack of consensus creates one more confusing message about the drugs they take. The latest flap about Serevent prompted some patients to stop using it - and doctors say that can be dangerous.

A novel treatment when it was introduced, Serevent provided asthma sufferers a spray that could be used twice a day, instead of every three or four hours, to keep bronchial tubes open and prevent attacks. It was designed to be used along with a steroid mist, and was never intended to treat an attack, when a fast-acting agent is required.

Officials at GSK said Serevent was rigorously tested as part of the U.S. approval process. When used correctly, they say, it helps millions of people ward off asthma attacks.

"It has a very good safety record," said Dr. Kathleen A. Rickard, vice president of respiratory and clinical development and medical affairs at GSK.

But problems were reported before the drug was available in the United States. After it was marketed in Europe in 1990, some users had severe attacks that resulted in hospitalizations and death.

Larry Sasich, a pharmacist and research analyst with the consumer protection group Public Citizen, said Serevent is in a family of drugs called beta-agonists that have a history of causing asthma problems as far back as the 1960s.

After Serevent's approval in the United States, studies documented problems with beta-agonist drugs in general, and the FDA got specific reports of asthma deaths associated with Serevent.

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(Distributed by Scripps Howard News Service, http://www.shns.com.)