WSJ.com - Glaxo Adds Risks To Label Warning For ADHD Drug

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August 22, 2006

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Glaxo Adds RisksTo Label WarningFor ADHD Drug

By ANNA WILDE MATHEWSAugust 22, 2006; Page D3

GlaxoKline PLC became the latest drug maker to add new safety warnings to the label of a stimulant medicine used to treat attention deficit hyperactivity disorder, in response to a request from the Food and Drug Administration.

The new language for the label of Dexedrine, highlighting potential cardiovascular risks and psychiatric side effects, was posted yesterday on the FDA Web site. Similar information was added earlier to the labels for other drugs in the category, including & 's Concerta and Shire PLC's Adderall, according to the firms.

An FDA spokeswoman said the agency asked in May for companies to "strengthen the wording in the warnings section with regard to serious cardiovascular events and psychiatric events." The FDA decided the "possible cardiovascular and psychiatric risks would be best addressed by new warning language, but did not justify a black box," she said. All the companies have responded to the request, and the "responses are currently under review," she said.

The wording on the Dexedrine label, which is similar to that now on the labels of other ADHD stimulant drugs, warns that sudden death has been reported in children taking the drugs who have cardiac abnormalities or other serious heart problems. The label says that, before patients get these drugs, doctors should check for family history of heart problems and do a physical examination for signs of such issues. It also says sudden deaths, strokes and heart attacks have been reported in adults taking the drugs, though the role of the stimulants in those events is unknown.

The warning also says "psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history" of such problems "can be caused by stimulants at usual doses." This occurs rarely, but if it does, it may be appropriate to discontinue use of the drug, the label says.

Write to Wilde Mathews at anna.mathews@...1

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