Personal Injury Law

Plavix Not Effective In All - FDA Inquiry

By Jane Akre

Today the Food and Drug Administration notified healthcare professionals that Plavix, (clopidogrel bisulfate) is less effective in some patients than others and it will try and determine why.

The difference may be due to genetic factors in the way the body metabolizes clopidogrel.  The other possibility to be explored is whether the use of certain other drugs with Plavix interferes with how the body metabolizes it.  The news comes after studies found that the blockbuster drug had mixed reviews on effectiveness.

Plavix is an antiplatelet drug used to prevent blood clots that could lead to heart attack and stroke in patients at risk.

Plavix is first metabolized by the body before it can be biologically active enough to prevent blood clots. Plavix can irritate the stomach so is frequently given with PPIs including Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Nexium, all prescription medications with the exception of Prilosec OTC.

There are reports that taking proton pump inhibitors (PPIs) may make Plavix less effective.

Drugmakers Sanofi-Aventis and Bristol-Myers Squibb say they will work with the FDA to conduct additional studies on genetic factors that may affect clopidogrel.

Laura Hortas, a spokeswoman for Bristol, tells Reuters she has no information on how many studies the companies would need or how long they would take. The finding "will allow us to understand and characterize the factors that may influence this complex issue," she said on behalf of both companies.

The FDA encourages that anyone taking Plavix should be re-evaluated as to whether they should continue treatment with a PPI, including Prilosec OTC.  #

Full post as published by InjuryBoard on January 26, 2009 (boomark / email).