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Injured by Foradil?
Foradil received FDA approval on February 16, 2001 to treat asthma. The FDA’s Pulmonary-Allergy Drugs Advisory Committee said on July 13, 2005 that Foradil, manufactured by Novartis; (Generic: Formoterol), should add a “black box” warning stating safety issues associated with GlaxoSmithKline’s Serevent, a similar drug in the class.The committee voted 12 to zero, with one abstention, that labeling for Foradil (formoterol) should include a warning citing asthma-related deaths seen with Serevent (Salmeterol). Labeling for Serevent, and combination product Advair (Salmeterol/Fluticasone), was modified in September 2004 to incorporate statistics from the SMART study. The study illustrated a 1.71 relative risk of asthma death or life-threatening experience with use of Salmeterol compared to placebo. The drugs added a boxed warning in August 2003 based on the preliminary results of the study.
The committee members felt that adding a warning to Foradil would alert physicians and patients that the drug might be no safer than Salmeterol products. The burden should be on Novartis to show that Formoterol has a different mechanistic or safety profile from Salmeterol, committee members said. The committee members also recommended the dissemination of more physician and patient information on the risks of Salmeterol products, including a patient medication guide.
Foradil Label Update
The FDA announced on May 16, 2006 that the product label for Foradil has been updated with a warning that the drug might increase the chance of severe asthma attacks that can result in death.
If you or a loved one took Foradil and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
ForadilRSS Feed
FDA Seeks Info on Serevent, Advair, Foradil As Part of Safety Review
Mar 6, 2008 | Parker Waichman Alonso LLP
Asthma drugs, including Serevent, Advair, Foradil, are the subject of a Food & Drug Administration (FDA) safety review. The FDA has requested information from the manufacturers of the asthma medications as part of an ongoing safety review of the drugs in children. Serevent, Advair and Foradil are long-acting beta 2-adrenergic agonists that prevent the release of substances in the body that cause inflammation of airways in the lungs. In 2005, the FDA...
Researchers Say "Killer" Asthma Inhalers Should Be Recalled
Jun 20, 2006 | Consumer Affairs
Researchers from Cornell and Stanford universities have concluded three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market. The researchers made their recommendation after concluding a search of medical literature. They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who...
Asthma inhalers causing deaths - study
Jun 20, 2006 | UPI
Three asthma inhalers with salmeterol or formoterol may cause 80 percent of U.S. asthma deaths annually, says a new study. Because of the possible health risks, these products sold as GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil should be recalled, said researchers at Cornell University and Stanford University. "These asthma deaths are generally (occurring) in healthy young adults," said Stanford researcher Shelly Salpeter. "We estimate that approximately 4,000...
Common Asthma Inhalers Cause Up to 80% of Asthma-Related Deaths, Cornell and Stanford Researchers Assert
Jun 9, 2006 | www.docguide.com
Three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market, researchers from Cornell and Stanford universities have concluded after a search of medical literature. They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade...
Advair, Other Asthma Drug Get Label Alerts
Mar 6, 2006 | AP
The asthma medication Advair and a related drug will bear stronger warnings of an increased risk of death associated with one of their ingredients.The revised warnings apply to Advair and Serevent, Food and Drug Administration spokeswoman Laura Alvey said Monday. Advair is GlaxoSmithKline's best-selling product, and Serevent is another of the British company's drugs.The updated versions of the "black-box" warnings on both drugs caution that salmeterol, one of the active ingredients in...
Foradil
Quick Facts
Foradil Reference Guide
Generic Name
Formoterol
Date Approved
February 16, 2001
Manufacturer
Novartis
Status
7/13/05 Black box warning
Approved Uses
Asthma
Serious Side Effects
Asthma-related fatalities
Related Topics
Advair
Serevent
Asthma
Defective Drugs
Diseases
Formoterol
Date Approved
February 16, 2001
Manufacturer
Novartis
Status
7/13/05 Black box warning
Approved Uses
Asthma
Serious Side Effects
Asthma-related fatalities
Related Topics
Advair
Serevent
Asthma
Defective Drugs
Diseases
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