FDA seeking additional data on asthma drugs

Adverse Event Reporting News,  March 11, 2008  

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FDA March 5 requested additional information from manufacturers of certain asthma drugs as part of an ongoing safety review of the drugs in children, CNNMoney reported this week.

The agency also said it will schedule another advisory panel later this year or early next year to evaluate any new information on the drugs, which include GlaxoSmithKline's Serevent and Advair, Novartis' and Schering-Plough's Foradil and AstraZeneca's Symbicort.

The drugs are considered long-acting beta agonists and are used for long-term prevention of asthma. The products currently carry a black box warning stating they "may increase the risk of asthma-related death."

In November, FDA's pediatric advisory panel said the drugs' labels needed new language more specific to children after a routine review of adverse event reports related to Serevent. The panel also said there should be more prominent language noting that the drugs should be used in combination with other drugs designed to control acute asthma attacks and not alone.

National treatment guidelines recommend low-dose, inhaled corticosteroids for routine management of the disease along with an inhaler to manage attacks. The guidelines recommend that drugs such as Serevent, Advair and Foradil should be used only as add-on therapy in patients 12 and older whose asthma isn't controlled by corticosteroids.

FDA said it would take several months to get the information and then review it. Agency officials have previously said the drugs should remain available for use in children.

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