The FDA received reports of life-threatening respiratory problems and deaths among users of the asthma drug Serevent within the first six months of its approval in 1994.

The FDA had asked the panel to review the safety of Glaxo's Serevent and blockbuster Advair -- a combination product containing Serevent and a corticosteroid -- and Novartis' Foradil, which belongs to the same class of drugs as Serevent.

The medications are long-lasting bronchodilators, which widen the lung's air passages and ease breathing. And they are marketed as daily treatments to help keep asthma and chronic obstructive pulmonary disease in check. Wednesday's meeting focused only on their use in treating asthma.

Severe Exacerbations

The FDA received reports of life-threatening respiratory problems and deaths in Serevent users within the first six months of its approval in 1994, agency medical officer Sally Seymour told the panel.

In a post-marketing study of Serevent and the final phase of Foradil's pre-approval studies, a small number of patients experienced severe exacerbations of their asthma. The much larger Serevent study suggested that African-Americans were particularly at risk.

As a result of the post-marketing study's findings, a black-box warning -- the strongest type of drug warning -- was added to Serevent's and Advair's labels in 2003.

The advisory panel Wednesday also unanimously recommended that the FDA require a comparable black-box warning on Foradil's label, which currently has none.

"I have concerns that, until proven otherwise, we have to make ourselves believe that Foradil may act the same way" as Serevent, said panel member Steven Gay, a lung specialist with the University of Michigan Health System. The FDA usually follows its advisory panels' recommendations.

Same Fate as Vioxx?

Serevent gained notoriety last November when FDA whistle-blower David Graham, speaking to a Senate committee, named it as one of five drugs that might deserve the same fate as Vioxx, the blockbuster arthritis drug that was pulled off the market in September because of safety concerns.

One of the other four, arthritis drug Bextra, was taken off the market in April.

FDA spokeswoman Laura Alvey said Graham's comments about Serevent were not why the agency convened Wednesday's meeting, which, she said, had been "in the works for a long time."

'Different Pharmacology'

In a statement after the meeting, Novartis and Schering-Plough, which sells Foradil in the USA, said that "though Foradil and Serevent have different pharmacology," the companies would work closely with the agency if it decides to revise Foradil's label.

In 2004, Advair's US sales of $2.4 billion were 10 times that of Serevent's $236 million, Glaxo spokeswoman Lisa Behrens said.

Foradil's worldwide sales in 2004 totaled $320 million, Novartis spokesman John Kouten said.