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Advair Recall

In July 2005, the FDA's Pulmonary Allergy Drugs Advisory Committee convened to discuss the possibility of an Advair recall. This committee was comprised of fourteen medical respiratory experts, who gathered to consider the current information about Advair and two similar medications, Serevent and Foradil.

An Advair recall became a possibility after studies indicated that the drug's active ingredient, salmeterol, might increase a patient's risk of suffering asthma or respiratory related injuries or death. Salmeterol is used in both Advair and Serevent, both produced by pharmaceutical company GlaxoSmithKline. While Serevent only contains salmeterol, Advair contains an additional active ingredient: an anti-inflammatory steroid called fluticasone.

In 1996, GlaxoSmithKline began a 28-week clinical trial designed to determine the effects of Serevent compared to a placebo. Of the study's 13,179 participants using Serevent, 13 patients died after suffering an adverse respiratory reaction caused by the medication itself. For comparison, three of the 13,176 participants taking a placebo died during the study.

The SMART study also discovered the risk of deadly side effects was much more likely in the African American subgroup of the trial. Caucasian participants, who comprised 71 percent of the trial subjects, did not have a statistically significant increase in serious side effect risks. African Americans, who comprised 17 percent of the patient population studied, were found to be at greater risk for life-threatening drug side effects. Researchers point out that, while the risk is greater for African Americans, less than one percent of these patients suffered a fatal drug reaction.

Amidst talk of a possible Advair recall, the FDA ordered the addition of a black box warning to Advair and Serevent packaging. This black box, the strongest warning the FDA can issue short of an Advair recall, was added to drug labeling in August 2003. This warning informs consumers about the rare but serious risk of respiratory and asthma related complications that can occur with use of Advair.

The advisory panel convened to determine whether or not an Advair recall should be issued voted unanimously to allow this and similar medications to remain on the market. Based on their thorough analysis, the FDA's respiratory experts determined that, for most patients, the benefits of Advair outweigh the drug's risks. The panel recommended that further research be conducted to determine the respiratory effects of taking Advair, Serevent, and Foradil.

If you would like to learn more about the Advair recall discussions or have been injured while taking this drug, please contact us to speak with a qualified and experienced attorney in your area. This legal professional can evaluate your case to determine the best way to protect and maximize your legal interests.

Contact a Advair Recall Lawyer

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