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FDA Scrutinizes Asthma Medication

Posted on: Wednesday, 13 July 2005, 15:00 CDT

Jul. 13--An asthma medication that a government whistle-blower has called one of the five most dangerous drugs in the United States will come under scrutiny at a Food and Drug Administration meeting today.

Serevent, a powdered medication inhaled by asthma patients to keep their airways open, will be a focus of an FDA Pulmonary-Allergy Drugs Advisory Committee meeting.

Serevent has been linked to 13 deaths related to asthmatic symptoms in patients who took the drug to avoid asthma attacks, and critics say its risks have been glossed over by the FDA and the drug's manufacturer, GlaxoSmithKline.

FDA spokeswoman Laura Alvey said agency officials had no comment.

The meeting, which will address the safety of the entire class of drugs to which Serevent belongs, comes more than six months after Dr. David Graham, an FDA drug safety reviewer, fingered Serevent as one of the most risky drugs on sale in the United States in his testimony on the dangers of Vioxx before the Senate Finance Committee.

His testimony helped prompt a similar FDA meeting in February to discuss Cox-2 inhibitor painkillers, after which Manhattan-based Pfizer suspended Bextra sales.

FDA documents released yesterday indicate that about a year ago, the agency asked Glaxo to strengthen Serevent's existing so-called black box warning, the most serious a drug label can carry. The FDA wanted the label to say that a study found a "a small but significant" risk for asthma-related deaths in all Serevent users, not just African-Americans, as previously indicated.

Glaxo spokeswoman Lisa Behrens said the company made the requested label changes in September.

However, in an interview yesterday, Graham accused the FDA of letting Glaxo hide behind statistics so Serevent could stay on the market.

"It's fine for people to hide behind statistics; that's what the FDA has done," Graham said. "This misuse of statistics guarantees that unsafe drugs will be approved for marketing."

Glaxo halted its study of Serevent in 2003 after finding that it couldn't enroll enough people and that there was a slight increase in asthma-related deaths in Serevent patients compared to those taking a placebo.

Glaxo said African-Americans seemed especially vulnerable, which it noted in its label warning. Graham contends the warning should have indicated an equal risk among all users.

Dr. Kathy Rickard, a pulmonologist and vice president of Glaxo's respiratory medicine development center, defended Serevent, saying it had proven to be very effective. She said Serevent patients should take it with corticosteroids and those who do not could be at increased risk for asthma attacks.

Dr. Michael Iannuzzi, chief of pulmonary, critical care and sleep medicine at Mount Sinai Hospital in Manhattan, said he has seen no problems in his own patients who take corticosteroids along with Serevent, but has observed difficulties in people who take Serevent alone.

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Source: Newsday, Melville, N.Y.

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