Thursday, March 15, 2007

migraine news roundup 28

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The FDA is requiring the makers of 13 sleeping pills to add warnings about the possibility of unexpected, bizarre, and highly dangerous side effects.

F.D.A. Warns of Sleeping Pills’ Strange Effects
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The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, the Food and Drug Administration said yesterday, announcing that strong new warnings will be placed on the labels of 13 drugs.

The agency also ordered the makers of the well-known drugs Ambien and Lunesta and the producers of 11 other commonly used sleeping pills to create patient fliers explaining how to use them safely.

The fliers, which the agency says it requires when it sees a significant public health concern, will be handed out at pharmacies when consumers fill their prescriptions.

Although the agency says that problems with the drugs are rare, reports of the unusual side effects have grown as use of sleeping pills have increased.

This is awesome news for migraineurs using Depakote for prevention:

Mylan's generic Depakote gets tentative OK
Mylan said Wednesday the U.S. Food and Drug Administration granted tentative approval to its generic version of Abbott's Depakote ER.

The tentative approval means Mylan may not launch its generic drug until the patent on Depakote ER expires. Mylan is seeking approval for 250 mg and 500 mg strengths of its tablets, known by the generic name divalproex sodium extended-release.

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