News | November 17, 2009

FDA Warns PPIs Impact Effectiveness of Clopidogrel

November 17, 2009 – The U.S. Food and Drug Administration (FDA) today warned new safety information shows an interaction between the anti-clotting medication clopidogrel (Plavix) and the proton pump inhibitor (PPI) omeprazole (Prilosec/Prilosec OTC), used to reduce stomach acid. 

The FDA said new data shows when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole, warned the FDA. Data showed separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

The FDA also said there are other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel. These include cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. 

Clinical studies showing PPIs may reduce the effectiveness of clopidogrel were first released more than a year ago. Today’s announcement was in response to new clinical data.

For more information: www.fda.gov/Safety/MedWatch

Related Content

Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat
News | Pharmaceuticals | June 14, 2019
Quantum Genomics announced the enrollment of the first patient in its QUORUM Phase IIb study of its lead clinical...
FDA Grants Priority Review for Vascepa sNDA
News | Pharmaceuticals | May 29, 2019
Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has...
Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Overlay Init