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clopidogrel FDA Alerts

The FDA Alert(s) below may be specifically about clopidogrel or relate to a group or class of drugs which include clopidogrel.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for clopidogrel

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

Jan 11, 2018

Audience: Pharmacy, Patient

ISSUE: International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening.

  • NDC# 54458-888-16
  • Lot# 117099A

BACKGROUND: Clopidogrel Tablets USP 75 mg are a platelet inhibitor (blood thinner) indicated for the use in patients with acute coronary syndrome, recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.

The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all US States.

RECOMMENDATION: International Laboratories, LLC is notifying distributors and customers by letter and is arranging for return of all recalled products. Consumers who have purchased this product should stop using and return the product to the location of purchase for a full refund. For questions regarding return of product please call Inmar at 855-258-7280 or via email internationallabs@inmar.com or by using mailing address Recall Coordinator, 635 Vine St., Winston Salem, NC 27101. Inmar’s business hours are (Monday – Friday 9 AM – 5 PM EST).

Consumers should also contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[01/10/2018 - Press Release - International Laboratories]

Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death

Nov 6, 2015

Audience: Cardiology, Hematology, Surgery

ISSUE: An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.

In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.

FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.

BACKGROUND: Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions.

RECOMMENDATION: Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health care professional if you have any questions or concerns about clopidogrel.

Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment.  See the Drug Safety Communication for more information, including Additional Information for Patients, Caregivers, and Health Care Professionals, and a Data Summary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/06/2015 - Drug Safety Communication - FDA]

Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

Nov 16, 2014

Audience: Cardiology, Hematology, Surgery

[Posted 11/16/2014]

ISSUE: FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases. 

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. 

BACKGROUND: The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

RECOMMENDATION: Health care professionals should not change the way they prescribe these drugs at this time. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/16/2014 - Safety Announcement - FDA]

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

Nov 17, 2009

Audience: Cardiovascular healthcare professionals, pharmacists

FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid.  New data show that 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. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. 

Recommendations for healthcare professionals are provided in the "Information for Healthcare Professionals" sheet.

[11/17/2009 - Information for Healthcare Professionals - FDA]
[11/17/2009 - FDA]
[11/17/2009 - Follow-Up to January 2009 Early Communication - FDA]

Clopidogrel bisulfate (marketed as Plavix)

Jan 26, 2009

Audience: Cardiovascular healthcare professionals, Pharmacists

[Posted 01/26/2009] FDA notified healthcare professionals that the makers of Plavix have agreed to work with FDA to conduct studies to obtain additional information that will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) on the effectiveness of clopidogrel. FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel. The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time. It could take several months to complete the studies and analyze the results. Until further information is available FDA recommends the following:

  • Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
  • Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel. 
  • Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking a PPI, including Prilosec OTC.


[January 26, 2009 - Early Communication about an Ongoing Safety Review - FDA]

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