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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.
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FDA Seeks to Limit Use of Serevent, Advair, Symbicort and Foradil

Feb 19, 2010 | Parker Waichman Alonso LLP
U.S. regulators want to limit the use of Serevent, Advair, Symbicort and Foradil.  The four drugs, part of a class of asthma medications known as long-acting beta agonists (LABAs), are being subjected to new restrictions, the U.S. Food & Drug Administration (FDA) has announced. These drugs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations announced by the FDA only apply to the use of LABAs in the treatment of...

FDA Panel Wants Restrictions on Two Asthma Drugs

Dec 12, 2008 | Parker Waichman Alonso LLP
A U.S. Food and Drug Administration (FDA) panel has called for restrictions on two asthma treatments:  Serevent and Foradil.  Both belong to a class  of drugs known as long-acting beta-agonists.  Both contain a drug that relaxes muscles around airways, said WHEC TV, but may also mask symptoms that can prompt deadly asthma attacks.  Although the expert 27-member panel found Serevent and Foradil drugs present greater risks than benefits and should not be used in the...

FDA Considers Heart Risks of Serevent, Foradil, Advair and Symbicort

Dec 11, 2008 | Parker Waichman Alonso LLP
One expert estimates that long-acting beta-agonists (LABAs)  - a class of asthma drugs that includes Serevent, Foradil, Advair, and Symbicort - might be responsible for about 14,000 deaths, Reuters is reporting.  The comments were part of a confrontational meeting between the U.S. Food and Drug Administration (FDA) and an advisory panel discussing how to handle increased risks experienced with the inhaled asthma medications called LABAs, said Reuters, LABAs are used by millions of...

Complications, Deaths Seen with Some Long-Acting Asthma Drugs

Dec 5, 2008 | Parker Waichman Alonso LLP
Some asthma drugs in a class  known as long-acting beta agonists (LABA) can increase the risk of death and complications, a new Food & Drug Administration (FDA) analysis has found.  The analysis looked at GlaxoSmithKline PLC's Serevent and Advair, Novartis AG's and Schering-Plough Corp.'s Foradil and AstraZeneca PLC's Symbicort.The FDA analysis was prepared for an advisory committee meeting next week that is slated to discuss the safety of the drugs, The Wall Street Journal...

Asthma Drug Linked to Serious Adverse Events

Oct 17, 2008 | Parker Waichman Alonso LLP
The asthma drug formoterol, sold under the brand names Foradil (Novartis), Oxis (AstraZeneca), Atock (Astellas) and Perforomist, has been linked to an increased risk of non-fatal, serious adverse events, according to a new study.  The study,  conducted by  Cochrane Researchers, found that people who took the drug daily for at least 12 weeks showed a significantly increased risk than those who took a placebo.Formoterol is a long-acting beta2-agonist which is inhaled to help open...

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