Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC

Published: Wednesday, November 25, 2009
Last Updated: Wednesday, November 25, 2009
Bookmark and Share
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be reduced by about half. “Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Div

New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

“Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “However, patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.

Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.

After issuing an Early Communication in January about possible drug interactions involving Plavix, the FDA requested new studies from the drug’s manufacturers, sanofi-aventis and Bristol-Myers-Squibb. These new studies support the existence of a significant interaction that could negatively impact a person’s health. Based on the current scientific information, the Plavix label has been updated with new warnings about the use of Prilosec and other drugs that inhibit the CYP2C19 enzyme and that could interact with Plavix in the same way.

The new studies compared people who took Plavix and Prilosec together with people who took Plavix alone. A reduction in Plavix’s anti-clotting effect was found in those individuals who took the combination. Similar results were seen irrespective of whether the two drugs were taken at the same or different times of day.

It is unknown how other PPIs may interfere with Plavix. Other drugs that should not be used with Plavix because they may have a similar interaction with CYP2C19 include Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).

Patients who take Plavix and need to take a drug to reduce stomach acid should discuss their therapy with a health care professional. Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids do not inhibit the CYP2C19 enzyme and aren’t expected to interfere with the anti-clotting activity of Plavix.

Plavix’s manufacturers have agreed to continue conducting studies to explore this and other drug interactions. When the FDA has reviewed additional data, the agency will communicate any new recommendations or conclusions.

FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm190825.htm


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More Than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FDA Declares Trans Fatty Acids Unsafe for Consumption
TFAs are widely recognized as the most harmful fat with regard to causing cardiovascular disease (CVD).
Wednesday, July 15, 2015
FDA Seeks $4.9 billion to Implement the FDA Food Safety Modernization Act
FY 2016 request reflects a nine percent increase from FY 2015 budget, aims to improve the quality and safety of the medical products Americans use.
Monday, February 23, 2015
FDA Issues Additional Guidance For Outsourcing Facilities That Compound Sterile Human Drugs
Agency outlines details on registration, fees, and drug product reporting for outsourcing facilities.
Tuesday, November 25, 2014
FDA Rules Will See Calorie Counts on Menus
The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations.
Tuesday, November 25, 2014
FDA Food Safety Challenge
Challenge aims to spur new technologies for fighting foodborne illness.
Friday, September 26, 2014
FDA Allows Marketing of T2Candida
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample.
Tuesday, September 23, 2014
FDA Issues Guidance on Use of Nanotechnology in Food Production
The three final guidances and one draft guidance provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Tuesday, July 01, 2014
FDA Proposes New Expedited Access Program for Medical Devices
New program would provide earlier access to high-risk medical devices that address unmet needs in the treatment or diagnosis of patients with serious conditions.
Tuesday, April 22, 2014
FDA, EMA Strengthen Pharmacovigilance Collaboration
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance topics.
Thursday, February 20, 2014
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
Vaccine to supplement National Stockpile, not intended for commercial availability.
Wednesday, November 27, 2013
FDA Takes Step to Help Ensure the Safety of Imported Food
Agency releases new proposed rules under FSMA for verifying foreign suppliers and accrediting third-party auditors.
Monday, July 29, 2013
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Monday, May 20, 2013
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
Tuesday, May 14, 2013
FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Produce Safety
Public encouraged to comment on new proposals.
Monday, January 07, 2013
Scientific News
RNAi Screening Trends
Understand current trends and learn which application areas are expected to gain in popularity over the next few years.
The Genetic Roots of Adolescent Scoliosis
Scientists at the RIKEN Center for Integrative Medical Sciences in collaboration with Keio University in Japan have discovered a gene that is linked to susceptibility of Scoliosis.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
Understanding the Molecular Origin of Epigenetic Markers
Researchers at IRB Barcelona discover the molecular mechanism that determines how epigenetic markers influence gene expression.
HIV Susceptibility Linked to Little-Understood Immune Cell Class
High levels of diversity among immune cells called natural killer cells may strongly predispose people to infection by HIV, and may be driven by prior viral exposures, according to a new study.
Diagnostic Test Developed for Enterovirus D68
researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test to quickly detect enterovirus D68 (EV-D68), a respiratory virus that caused unusually severe illness in children last year.
How a Kernel Got Naked and Corn Became King
Ten thousand years ago, a golden grain got naked, brought people together and grew to become one of the top agricultural commodities on the planet.
Sweet Revenge Against Superbugs
A special type of synthetic sugar could be the latest weapon in the fight against superbugs.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!