J&J Birth Control Patch Ortho Evra Safety Review Will Focus On Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: 

• Transcript for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee  (PDF – 685KB)
• Minutes for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee  (PDF – 82KB)

(2/17/12)

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UPDATE:  "FDA advisers: Ortho Evra patch needs clearer label" (12/9/11, Reuters)

(12/12/11)

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In October 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included new findings about the safety of the Ortho Evra birth control skin patch.

In an earlier article, "Ortho Evra Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Deep Vein Thrombosis & Pulmonary Embolism", we said it seemed highly likely these October 2011 FDA study findings about Ortho Evra side effects would be presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place December 9, 2011.

On December 6, 2011 the FDA made available online the following background material for this Ortho Evra safety review meeting:

• Draft Agenda for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Draft Questions for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Draft Meeting Roster for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Advisory Committee for Reproductive Health Drugs Committee Roster for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Drug Safety and Risk Management Advisory Committee Roster for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Briefing Information for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

Like others, we look forward to hearing the presentations and discussions about the safety profile of Ortho Evra at this FDA advisory committees meeting.

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