Dabigatran FDA Alerts

Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

March 22, 2023 - Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are indicated in the table belov,:. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022.

Wholesalers/distributors and pharmacies with an existing inventory of the lots listed in the table above, should stop use and distribution and quarantine the product immediately.

Wholesalers and Distributors are advised to recall the distributed product. Please notify any accounts or additional locations that may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Ascend requests that they immediately cease distribution of the affected product.

Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 7 days a week.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: Ascend Laboratories LLC

Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.

BACKGROUND: Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF).

RECOMMENDATION: Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[05/13/2014 - Drug Safety Communication - FDA]

Previous Related Drug Safety Communication:
[12/19/2012 - Drug Safety Communication- FDA]

Previous Related Safety Alert:
[11/02/2012 - Pradaxa MedWatch Safety Alert - FDA]

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves

ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.
 

BACKGROUND:  Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat rapidly and irregularly.  Pradaxa is not indicated for patients with atrial fibrillation caused by heart valve problems.
 

RECOMMENDATION: Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.  The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment.  Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Pradaxa to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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.

[12/19/2012 - Drug Safety Communication - FDA]

Previous Related Safety Alert:
[11/02/2012 - Pradaxa MedWatch Safety Alert - FDA]

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

UPDATED 11/02/2012. The FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue. See the Data Summary in the 11/02/2012 Drug Safety Communication below for additional information.

FDA has not changed its recommendations regarding Pradaxa. Pradaxa provides an important health benefit when used as directed. Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke. Strokes can lead to permanent disability and death.

Posted 12/07/2011

AUDIENCE: Cardiology, Pharmacy, Hematology

ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[11/02/2012 - Drug Safety Communication - FDA]
[12/07/2011 - Drug Safety Communication - FDA]

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[12/07/2011 - Drug Safety Communication - FDA]