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Foradil

On July 13, 2005, the FDA's Pulmonary-Allergy Drugs Advisory Committee considered whether Novartis' Foradil and GlaxoSmithKline's Serevent and Advair should remain on the market. The committee of 14 asthma experts reviewed the data on the drugs and voted on whether currently available data supported continued marketing of the drugs. More than 21 million adults and eight million children in the United States have asthma.

The panel unanimously recommended the three asthma drugs remain on the market, but the committee urged more research to determine if the drugs might actually worsen asthma in certain patients. The panel also unanimously recommended the FDA require a black-box warning on Foradil's label.

In 2003, black-box warnings were added to Serevent's and Advair's labels - the FDA's strictest drug issued warnings - after a post-marketing study of Serevent and the final phase of Foradil's pre-approval showed a small, but significant, number of patients experienced severe exacerbations of their asthma. Foradil does not contain salmeterol, and did not have to carry the new warnings, but according to a panel member, Steven Gay, a lung specialist with the University of Michigan Health System, unless proven otherwise it must be assumed that the drug has the same effect as Serevent and Advair.

The drugs gained notoriety in November 2004 after FDA whistleblower David Graham named Serevent as one of five drugs that might be tied to safety concerns when speaking out about what he believed was the FDA's inability to protect the public from unsafe drugs. An FDA spokeswoman said Graham's comments regarding Serevent were not why the agency convened the advisory meeting on Foradil, Serevent and Advair and that it had been "in the works for a long time."

In a statement following the FDA advisory meeting, Novartis and Schering-Plough, which sells Foradil in the U.S., said that despite the differences in pharmacology Foradil and Serevent have, the companies would work closely with the agency should they decide to revise Foradil's label. The FDA is not required to accept its panel's recommendations, but the agency usually does.

In a Phase II trial comparing Foradil 12 mcg twice daily, Foradil 24 mcg twice-daily and placebo, there were four serious asthma exacerbations in the 24 mcg arm compared to zero in the 12 mcg and placebo arms. When Novartis conducted a 2,307 patient Phase IV examining the risk of acute exacerbation and worsening of asthma with 12 mcg and 24 mcg doses, two asthma exacerbations appeared with Foradil 24 mcg and five events appeared in with Foradil 12 mcg, compared to one even with placebo.

In 2004, Foradil worldwide sales totaled $320 million, according to a Novartis spokesman.

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