Plavix/PPI interactions linked to heart attacks
This article was originally published in The Tan Sheet
FDA says Jan. 26 it is looking at evidence that the Sanofi-Aventis/Bristol-Myers Squibb antiplatelet drug Plavix(clopidogrel) may be less effective when used with proton pump inhibitors, including Prilosec OTC (omeprazole). A study published in the Canadian Medical Association Journal Jan. 28 finds PPIs may inhibit the enzyme that converts clopidogrel to the active drug form. Researchers led by David Juurlink, with the Sunnybrook Health Sciences Center in Toronto, estimate 5 percent to 15 percent of readmissions for heart attacks among patients taking clopidogrel could result from an adverse reaction with some types of PPIs. They did not find evidence that H2 blockers, including Zantac and Pepcid, or antacids interfere with Plavix. The drugmakers and FDA will conduct additional studies on how other drugs affect clopidogrel, the agency adds. An FDA MedWatch notice asks health care providers to reevaluate their treatment of patients with both Plavix and a PPI, in light of the existing data
You may also be interested in...
An FDA warning that people prescribed Plavix (clopidogrel) should not take specific heartburn drugs creates a significant opportunity for other OTC products in the category "to make some hay," a marketing consultant said
PPIs do not counteract anti-clotting drugs: The use of proton pump inhibitors like Prilosec OTC (omeprazole) does not significantly increase the risk of cardiovascular events in patients who take anticlotting drugs like Plavix (clopidogrel) or Effient (prasugrel) according to a study in the Sept. 1 issue of The Lancet. The research, led by Michelle O'Donoghue, of Brigham & Women's Hospital in Boston, contradicts other recent studies that found PPIs may inhibit the enzyme that converts clopidogrel to the active drug form (1"The Tan Sheet" Feb. 2, 2009). However, the researchers acknowledged a "modest attenuation of the in-vitro antiplatelet effects" of clopidogrel and prasugrel during PPI use. The researchers based their conclusion on two double-blind studies with a total of 13,809 subjects receiving cardiovascular-related treatments
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.