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FDA Officials Warn on Asthma Drug Risks

Certain inhaled asthma medications may cause the risk of death to asthma sufferers, and should not be used by people under 18 years of age, according to statements released Friday by officials with the U.S. Food and Drug Administration (FDA). The agency will conduct a comprehensive review of asthma drug safety later this month.

The warnings apply to inhaled asthma drugs that contain "long-acting beta agonist" (LABA) medication. These include Advair, Foradil, Serevent, and Symbicort. Reuters reports that "Staff in the Food and Drug Administration's drug-safety office unanimously have recommended withdrawing clearance of all long-acting beta agonist drugs (LABAs) for children under 18 amid evidence of an increased risk of asthma-related deaths and asthma attacks." And the drug safety officials "urged removing the approval of Serevent and Foradil for asthma in people of all ages," according to Reuters.

The New York Times reports that "Sudden deaths among asthmatics still clutching their inhalers have fed the debate" over the safety of asthma medications,"but trying to determine whether the deaths were caused by patients? breathing problems or the inhalers has proved difficult." In November, the FDA issued an update on the safety of asthma medications, announcing that it had asked the manufacturers of Advair, Brovana, Foradil Aerolizer, Perforomist, Serevent, and Symbicort "to provide information regarding controlled clinical studies conducted with these products to further evaluate their safety."

• Reuters: FDA Sees Asthma Drug Risks, Seeks Panel Advice
• New York Times: Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains
• FDA Safety Update: Asthma Medications
• FDA Index to Drug-Specific Information
• FDA MedWatch
• Pharmaceutical Drug Liability (FindLaw)
• Things You Should Know: Taking Prescription Medications (FindLaw)
• Defective and Dangerous Products (FindLaw)

Full post as published by FindLaw's Common Law on December 08, 2008 (boomark / email).