Foradil FDA Warnings

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.

Foradil Asthma Inhaler Death Lawsuit