J&J's Evra Canadian Label Includes Obesity, Sauna Warnings
This article was originally published in The Pink Sheet Daily
Revised labeling on risk of venous thromboembolism associated with the birth control patch in Canada appears stronger than FDA's revision on Ortho Evra.
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FDA requests J&J conduct longer follow up studies on the risk of serious blood clots, heart attack and stroke associated with the birth control patch.
The firm updated labeling to include a new bolded warning regarding increased hormone exposure with the patch versus oral contraceptives.
Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.