FDA Safety Update on Pradaxa Bleeding Complications

The U.S. Food and Drug Administration issued a new safety announcement on Nov. 2 about the risk of serious bleeding associated with Pradaxa, a blood thinner prescribed to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, a common heart rhythm abnormality.

Since the approval of Pradaxa in October 2010, the FDA has received a large number of reports of bleeding among Pradaxa users.

The FDA said its latest analysis indicates the rates of stomach and intestinal bleeding and brain bleeds among new users of Pradaxa do not appear to be higher than among new users of warfarin, a well-established blood thinner. Both Pradaxa and warfarin reduce the number of strokes among patients with heart rhythm abnormalities, the FDA said, but also cause potentially serious and fatal bleeding complications.

Bleeding complications are a recognized side effect for patients taking blood thinners. The FDA advised doctors who prescribe Pradaxa to follow the dosing recommendations carefully —especially for patients with weakened kidneys that don’t function normally. Pradaxa is eliminated through the kidneys.

The FDA is continuing to monitor multiple sources of data to assess the safety of Pradaxa. From the date of its approval through August 2012, doctors have issued approximately 3.7 prescriptions for Pradaxa and approximately 725,000 patients have received the medication from retail pharmacies.

Patients taking Pradaxa should be alert to the risks of uncontrolled internal bleeding, including catastrophic brain hemorrhaging and fatal bleeding in the brain, particularly after an accident or fall. If you have questions about taking the medication, contact your doctor.

If you believe that you or a family member has suffered a serious side effect from taking Pradaxa, talk to a knowledgeable drug injury attorney. Drug makers have a legal responsibility to make and market drugs that are safe and effective when used as intended. When drug makers harm patients who rely on the prescription drugs they take to be safe, the pharmaceutical companies should be held accountable.

The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe drugs and pharmaceutical manufacturers that put profits ahead of patient safety. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.

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