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

Dec 11, 2008 | Parker Waichman LLP

LABAs are used by millions of patients, many of whom are children, noted Reuters.  Advair and Symbicort use a LABA with an inhaled steroid; Serevent and Foradil (marketed in the U.S. by Schering-Plough Corp.) only contain LABAs, said Reuters.

Reuters explained that asthma, a chronic disease with symptoms that include restricted breathing and wheezing, can be fatal when untreated or uncontrolled.  About 20 million Americans suffer from asthma, according to the National Institutes of Health, said Reuters.  LABAs help relax airways to prevent the spasms that cause the attacks and are accompanied with warnings about a link to asthma-related deaths based on findings from a Glaxo study shut down in 2003, said Reuters.  

FDA reviewers argued that LABAs should never be prescribed to pediatric asthmatics and asked for revocation of Glaxo's Serevent and Novartis AG's Foradil for all asthma patients, regardless of age, reported Reuters.  "We now know with high certainty that LABAs increase asthma mortality.  Do the health benefits justify that?" asked FDA drug safety reviewer David Graham, said Reuters, who added that Graham has publicly criticized the FDA’s managing of drug risks.  Graham agued that LABAs benefits do not justify its risks, saying that he’s seen little improvement in asthma patients treated with LABAs, noting that as many as 14,000 deaths since 1994 can be linked to LABAs.

The FDA reviewed over 100 clinical trials that involved about 61,000 patients and found that for every 1,000 patients treated with a LABA, nearly three such patients experienced serious asthma-related complications, which included hospitalizations and death, Reuters said.  And, added Reuters, although each drug maker argued the benefits of its drugs and against banning LABAs, the advisory panel will vote next regarding the benefits and risks of each of the drugs.

Reuters noted that even if LABA approval for use in the treatment of asthma could face revocation, drugs such as Advair, Serevent, and Foradil could continue to be prescribed for patients suffering from chronic obstructive pulmonary disease (COPD).   Meanwhile, AstraZeneca has applied to the FDA for approval of is asthma drug, Symbicort, to be used in the treatment of COPD.

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