National
Overuse, Safety Questions Cloud Advair's Ascent to Asthma Blockbuster
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May 19, 2015 - 9:48:35 AM

(HealthNewsDigest.com) - The asthma drug Advair is one of the biggest blockbusters in pharmaceutical history, at $80 billion in sales and counting. Since its approval in 2000,  it has become a lifeline for sufferers of asthma, which affects roughly 25 million Americans. 

But an investigation by ProPublica's Jeff Gerth, co-published today with the Daily Beast, finds that manufacturers, regulators, doctors and the courts have repeatedly failed to stop the misuse of the drug, which carries an increased "risk of asthma-related death" from one of its two ingredients.

Key takeaways from Gerth's report, based on previously undisclosed or overlooked documents:

• Federal guidelines say Advair is inappropriate for patients with mild asthma, but the distinctive, easy-to-use purple inhaler is often prescribed for just that.
• In 2012, Advair's maker, GlaxoSmithKline, paid $700 million to settle federal civil allegations that unlawful promotion of Advair contributed to extensive misuse. The company has also faced scores of lawsuits and claims brought by those whose relatives have died while taking Advair, quietly settling many when pushed to the brink of disclosing sensitive internal documents.
• Concerns about the potentially harmful ingredient, salmeterol, emerged in a 1993 study, but it took the FDA until 2010 to require Glaxo and makers of similar drugs similar to Advair to launch studies big enough to assess the risks. Results aren't due until 2017. Meantime, millions of patients on the drugs - a class long dominated by Advair - remain exposed.
  

The full story is available here: http://www.propublica.org/article/overuse-safety-questions-cloud-advair-ascent-to-asthma-blockbuster; it is free to link to or republish under our Creative Commons license. Gerth, based in Washington, DC, is also available for interviews.

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