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The New York Times has reported that a panel of experts called in by the FDA has voted to ban the asthma drugs Serevent and Foradil. Both drugs can help open lung airways, but they carry an increased risk of death if taken without a steroid.
The experts noted that half of doctors who prescribe the two drugs fail to also prescribe a steroid. To complicate matters, many patients fail to take the steroid, even when it has been prescribed. Some patients apparently are concerned about the side effects of "steroids" prescribed for asthma patients, particularly young children. (Asthma patients are prescribed corticosteroids, which are an anti-inflammatory medication. The steroids that cause "roid rage" and get sports players into trouble are anabolic steroids, which are a different matter entirely.)
In 2006, the FDA required the makers of Serevent and Foradil to include a black box warning (so-called because the warning text is typically printed inside a black border) on the medications' package insert. However the FDA expert panel apparently feels that this has not been effective enough in encouraging patients to take an accompanying steroid. Black box warnings are the strongest measure the FDA can take, short of removing the drug from the market.
Serevent was approved for use in 1994. The FDA became concerned about Serevent in 1996, when the FDA "received post-marketing reports of several asthma deaths associated with the use of Serevent Inhalation Aerosol." GlaxoSmithKline began a long-term study to assess the risks of Serevent, but the study was halted in 2003 because GSK reported difficulty in keeping patients enrolled in the study, and announced doubts that the study's end results would be clear.
The makers of Serevent and Foradil, GlaxoSmithKline and Novartis and Schering-Plough, argue that the drugs should not be banned for use in asthma patients. The drug companies believe that "doctors want the freedom to mix and match these drugs with steroids." (One can't help but wonder, why should doctors be "given the freedom" to make decisions which endanger patients' health?) Both Serevent and Foradil are lucrative for their manufacturers. In 2007, Serevent earned $538 million in sales, and Foradil earned $362 million.
An asthma attack is actually the result of two linked problems: spasms in the airways of the lungs, and swelling of the airways. The spasms can be worsened by the swelling, and the swelling can itself cause spasms. Long term asthma controllers (as opposed to rescue inhalers) include a category of drugs called "beta agonists." These help to treat airway spasms. However, a beta agonist should always be taken in conjunction with a steroid, which will reduce swelling in the airways. When a beta agonist is taken without steroids to reduce airway swelling, it can actually cause more severe asthma attacks in the long term.
The panel of experts voted in favor of two other popular beta agonist asthma drugs, Advair and Symbicort. Both of these drugs combine beta agonists with a steroid, so that the patient doesn't have to take a steroid separately.
If you are currently taking Serevent or Foradil, either with or without a steroid medication, the FDA strongly advises that you NOT stop taking these medications without first talking to your doctor.
