Saturday, November 24, 2007

FDA Questions Child Safety of Glaxo Asthma Drugs Serevent and Advair

Article in the Wall Street Journal -- Questions the Safety Of Asthma Drugs for Kids, by Jenifer Corbett Dooren and Anna Wilde Mathews.  Here's an excerpt:

Food and Drug Administration drug-safety reviewers questioned whether the GlaxoSmithKline PLC asthma drugs Serevent and Advair are appropriate for use in pediatric patients, and said the issue needs further review.

The asthma-drug findings came in documents posted Friday in advance of a meeting of the FDA's pediatric advisory committee. The session, which starts Tuesday, is expected to focus on the safety of a number of drugs, including the influenza medications Tamiflu, from Roche Holding AG, and Relenza, made by Glaxo.

Serevent and Advair, which both contain the active ingredient salmeterol, already carry a strong "black box" label warning about a risk of asthma-related death. The agency's reviewers said they hadn't identified side effects unique to children.


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