Drug Safety Oversight Board Meeting, November 19, 2009

Drug Safety Oversight Board Meeting, November 19, 2009
Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on risk communications [Public Health Advisories (PHA), Early Communications about Ongoing Safety Reviews (EC), and Information for Healthcare Professionals (HCP)] posted and in development since the October 15, 2009 meeting. The following is a list of the posted risk communications:

. October 23, 2009: Peramivir
.. November 2, 2009: Exenatide (Byetta) and renal effects
... November 13, 2009: Potential contamination of products manufactured by Genzyme Corporation
.... November 13, 2009: Local anesthetics and chondrolysis
..... November 17, 2009: Clopidogrel and omeprazole interaction
- Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)
-- Information for Healthcare Professionals: Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC)

The DSB heard presentations and discussed the clinical implications and impact of the FDA action regarding a drug interaction involving clopidogrel and omeprazole on health care professionals, patients, and health care institutions. Clopidogrel inhibits platelets in the blood and is used to prevent blood clots after a recent heart attack or stroke. Omeprazole belongs to a class of drugs called proton pump inhibitors (PPI), and decreases the amount of acid produced in the stomach. Omeprazole is used to treat symptoms of gastroesophageal reflux disease and other conditions caused by excess stomach acid.

On November 17, 2009, FDA released three risk communications regarding clopidogrel (Update to an Early Communication, Public Health Advisory, and Information for Healthcare Professionals).
Board members from the Department of Defense, Veterans Health Administration, and the Indian Health Service provided information on clopidogrel and PPI usage patterns in their hospitals and clinics. They also provided input on how the recently issued risk communications affected their health systems. A guest speaker, the Director of the Cardiac Catheterization Laboratory and Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, provided the Board with a clinical perspective on the use of clopidogrel and PPIs.

The Board discussed the following:

* Pharmacokinetic and pharmacodynamic data demonstrating reduced blood levels of clopidogrel’s active metabolite and reduced inhibition of platelet aggregation with co-administration of omeprazole
* The pharmacogenomics of clopidogrel metabolism
* Several observational and epidemiological studies evaluating clinical outcomes in patients taking clopidogrel with omeprazole or another PPI
* A clinical trial (COGENT) evaluating gastrointestinal and cardiovascular adverse events in patients taking clopidogrel and omeprazole or another PPI
* The importance of the clopidogrel-omeprazole drug interaction from a clinical perspective
* The risks versus the benefits of continuing omeprazole or other PPI therapy in patients taking clopidogrel
* The clinical impact of the FDA communications on other Federal Agencies and the public

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Drug Safety Oversight Board Meeting, November 19, 2009