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Teva Zecuity's Safety: Burns Go From Non-Issue In Label To Product Puller

 
• By Brenda Sandburg

Fate of migraine patch remains uncertian after 'large number' of patients suffer burns and scars; adverse event was issue during review of transdermal sumatriptan product, but didn't even make it into labeling; nine months later the problems have forced Teva to suspend marketing.

Nine months after launching its migraine treatment Zecuity (sumatriptan iontophoretic transdermal system), Teva Pharmaceutical Industries Ltd. has voluntarily suspended marketing of the patch following patient reports of burning and scarring. The move caps a run of events in which the burns and scars went from a review concern, to a non-issue in labeling, to causing the product to be pulled from pharmacies.

Whether the product will return to market will depend on the outcome of investigations of the cause of the adverse...

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More from United States

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More from North America

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

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