Safety Alert: Clopidogrel

FDA Early Communication About an Ongoing Safety Review

The FDA announced that it is working with the makers of Plavix to study how genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) may alter the effectiveness of clopidogrel, the active ingredient in Plavix. This FDA action was prompted by recent reports suggesting clopidogrel does not work as well in some patients as it does in others. Differences in effectiveness may be due to changes in the way the body breaks down clopidogrel. iGuard discussed one of these studies in a previous alert issued in November 2008 related to use of Plavix and proton pump inhibitors (Aciphex, Nexium, Prevacid, Prilosec, or Protonix).

The FDA recognizes the importance of investigating these issues in a timely manner. However, it could take several months to complete the studies and analyze the results.

For more information please visit:

more information here

To read the November 2008 alert about this issue, please visit:

more information here

Source: FDA
Publication Date: 2009-Jan-27
Last Updated: 2009-Jun-05

What does this mean?

It is important not to draw too many conclusions about this early communication about CLOPIDOGREL (PLAVIX) until the new studies have been completed and the FDA releases a final review. In the mean time, you should continue to take your Plavix as directed because Plavix has shown benefits in preventing blood clots that could lead to a heart attack or stroke.

If you are also taking a proton pump inhibitor (PPI) or are considering taking a PPI, please talk to your doctor to evaluate the need for starting or continuing a PPI while also taking Plavix. PPIs are commonly used to treat heartburn by reducing acid production in the stomach. Examples of PPIs include omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), and esomeprazole (Nexium), which are all available by prescription. Omeprazole (Prilosec OTC) is also sold without a prescription (over-the-counter) for frequent heartburn.

If you have any questions about this safety alert, please talk to your doctor or pharmacist.

Vist theClopidogrel medication page for more information about Clopidogrel.

DISCLAIMER: iGuard is not intended to be a substitute for professional medical advice. iGuard cannot and does not take into consideration every possible interaction or account for individual responses to medicine. Different individuals may respond to medication in different ways. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient. Always seek the advice of a qualified health provider with any questions you may have before making any changes to your treatment. The use of the iGuard site and its content is at your own risk. The iGuard site and the information contained in it is intended for users in the United States and information in other countries may be different.

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