Safety Alerts & Recalls
What does this mean?
It is important not to become overly concerned about the results of this one new study that showed a very small increase in risk of heart attack and acute coronary syndrome amongst patients treated with Pradaxa. Please note that the FDA has not yet commented on the results of this study and if they do, MediGuard will send a communication at that time.
The benefits of Pradaxa continue to outweigh the risks of this medicine for most patients. If you take Pradaxa, please continue to take your medicine as directed by your healthcare professional. If you have any concerns about the information published in this new study or other concerns about your medicine, please follow up with your healthcare professional.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
New Study Study Finds Small Increased Risk of Heart Attack in Patients Treated with Pradaxa
In a new study published in the Archives of Internal Medicine, Pradaxa (Dabigatran) was associated with an increased risk of heart attack and acute coronary syndrome, a condition brought on by sudden, reduced blood flow to the heart. Pradaxa is a blood thinner that is approved by the FDA to lower risk of stroke in patients with a history of atrial fibrillation, a type of abnormal heart rhythm.
According to the study researchers, the actual increase in the number of heart attacks and acute coronary syndrome events was very small and is outweighed by the benefit of the drug's ability to reduce the number of strokes. Heart attacks and acute coronary syndrome events occurred in 1.19% of the Pradaxa patients, and in 0.79% of the control-group patient.
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