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Subscribe To Our Syndicated NewsFDA Proposes Advair Restriction
–November 21, 2005
The FDA announced today that Advair, also sold as Seretide, should only be prescribed to patients after similar medications have failed and should not be prescribed as a first-line asthma treatment. The FDA's proposal responds to studies indicating Advair side effects can cause a fatal worsening of one's asthma condition. As a result of this FDA proposal, shares in GlaxoSmithKline (the makers of Advair) have dropped five percent. Advair is GlaxoSmithKline's top-selling prescription drug.
According to financial analysts, twenty five percent of all Advair prescriptions are written as a front-line treatment for asthma and chronic pulmonary obstructive disorder (COPD). These prescriptions were given despite the black box warning on all Advair products indicating the life-threatening paradoxical effects of this medication. Current US guidelines for the treatment of moderate to severe persistent asthma say patients should receive a recommended steroid and long-acting beta agonist (LABA) as an initial treatment.
Advair combines a steroid (fluticasone) with a LABA to provide a single inhaled medication for the treatment of asthma and COPD. Serevent (salmeterol), also sold by GlaxoSmithKline, contains the LABA component of Advair. Both Serevent and Advair are included in the new FDA proposal. Novartis AG's asthma drug, Foradil, is also included in the warning, though it is not a salmeterol-based medication.
The fate of two other asthma drugs, not yet approved by the FDA, is threatened by this Advair warning. AstraZeneca recently filed for FDA approval of their asthma medication, Symbicort. Novartis is currently developing a product called QAB, also designed to treat asthma and COPD. Both of these new medications contain a LABA. Both may meet a similar fate as Advair.
There are other asthma medications that may soon be positioned as safer alternatives to Advair.
For more information on drug safety information, please contact us to confer with an attorney.
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