British drug maker GlaxoSmithKline is under fire again, this time concerning the safety of popular asthma medications Advair and Serevent. The top-selling drugs have been blockbusters for GSK, with Advair alone accounting for almost seven billion in sales in 2006. Concerns about the drugs’ safety stem from reports of rare and potentially life-threatening side effects in children under the age of 16. The FDA’s Pediatric Advisory Committee will be meeting this week to further address the issue.
GlaxoSmithKline seems to be rather optimistic about the future for these drugs and says that they are confident that the benefits of the drugs highly outweigh any risks.
There were nine cases of adverse events in children under 16 using Serevent, or salmeterol, in the year following granting of pediatric market exclusivity in March 2006, including five deaths.
The FDA has previously warned of possible dangers associated with these drugs. In 2005 an FDA warning advised patients that Advair and Serevent might sometimes trigger severe asthma attacks and death.
“While the FDA’s attention is unwelcome, any formal additional recommendations against use in children that would significantly affect prescribing behavior would seem some way off,” analysts at Deutsche Bank said in a note.
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