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Coumadin FDA Alerts

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

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 warfarin

FDA Warns Patients and Doctors About Recall of Home-Use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.

Feb 1, 2019

Audience: Consumer, Health Professional

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. Today, the FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.

The previous recall conducted by Roche, which is still in effect, involved more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. The CoaguChek XS PT Test Strips announced in today’s recall were manufactured by Roche, but distributed by Terrific Care/Medex Supply and include catalog numbers that were not included in the recent Roche recall because these strips were not labeled or authorized for sale in the U.S. and were only distributed by Roche Diagnostics outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the U.S.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” said FDA Commissioner Scott Gottlieb, M.D. “Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market.” 

As with the previous recall, the FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

Millions of Americans take the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots. The drug may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves. Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.

The FDA’s previous warning concerning the CoaguChek XS PT Test Strips was based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots.

Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, with atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.

The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.

Patients and health care providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method.

All health care providers, patients and caregivers, are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA’s voluntary reporting program. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.

The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to this recall when available.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter

Jul 1, 2014

Audience: Cardiology, Health Professionals

ISSUE:  Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur.

To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue.

Coumadin for Injection 5 mg single-use vials is packaged in cartons of six vials. The affected Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230.

BACKGROUND: Coumadin for Injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.

RECOMMENDATION: Anyone that has Coumadin for Injection which is being recalled should stop use and distribution and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for return of remaining stock. Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[06/30/2014 - Press Release - Bristol-Myers Squibb]

Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets

Jun 12, 2013

Audience: Pharmacy, Patient, Health Professional

ISSUE: Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.

Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.

BACKGROUND:  The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Product is packaged in HDPE Bottle of 1000's count, which may have been dispensed to patients in smaller bottles. The only lot affected of Warfarin 2 mg Tablets being recalled is Lot MM5767.

The product can be identified by its NDC #6838205310. The product was distributed nationwide in the United States to wholesalers/distributors, retailers and mail order providers, from November 2012 to December 2012.

RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this particular lot of Warfarin 2 mg Tablets.
Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In case patients have tablets of this lot of product, make sure all the tablets are of same size and if unsure, patients should consult their dispensing pharmacy.
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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

 

[06/10/13 - Firm Press Release - Zydus Pharmaceuticals Inc.]

Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

May 3, 2011

Audience: Cardiology, Pharmacy, Patients

ISSUE: Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.

BACKGROUND: Coumadin is prescribed to treat or prevent blood clots.

RECOMMENDATION: Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.


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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[05/02/2011 - Press Release - Bristol-Myers Squibb]

Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage

Feb 21, 2011

Audience: Pharmacy, Family Practice, Consumer

[UPDATED 02/21/2011] Expansion of Recall: Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven and Oxybutynin

[Posted 02/17/2011]

ISSUE: Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To date, the company has identified no additional mislabeled bottles. 

BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.   

RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832. Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).


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

Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage

Feb 17, 2011

Audience: Pharmacy, Family Practice, Consumer

ISSUE: Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To date, the company has identified no additional mislabeled bottles. 

BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.   

RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832. Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).


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

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[02/16/2011 - Press Release - Upsher-Smith Laboratories]
[02/16/2011 - Product Photos - Upsher-Smith Laboratories]

    

Coumadin 1 mg Tablet Blister Packs: Recall

Jul 14, 2010

Audience: Hematology, Cardiology, Risk Manager

ISSUE: Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.

The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.

BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.

RECOMMENDATION: See the company Press Release for additional contact information. 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:

  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178


[07/12/2010 - Press Release - Bristol-Myers Squibb]

    

Warfarin (marketed as Coumadin)

Aug 16, 2007

Audience: Hematologists, other healthcare providers, consumers

[Posted 08/16/2007] FDA approved updated labeling to include pharmacogenomics information to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for the widely used blood-thinning drug, Coumadin. This new information explains that people's genetic makeup may influence how they respond to the drug. Specifically, people with variations in two genes may need lower warfarin doses than people without these genetic variations. The two genes are called CYP2C9 and VKORC1. The CYP2C9 gene is involved in the breakdown (metabolism) of warfarin and the VKORC1 gene helps regulate the ability of warfarin to prevent blood from clotting.

The dosage and administration of warfarin must be individualized for each patient according to the particular patient's prothrombin time (PT) / International Normalized Ratio (INR) response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

[August 16, 2007 - Warfarin Press Conference - FDA]

Coumadin (warfarin sodium)

Oct 6, 2006

Audience: Pharmacists, other healthcare professionals, and patients

[Posted 10/06/2006] FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients.

The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.

[October 2006 - Medication Guide - Bristol-Myers Squibb]

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