Pradaxa Associated with Increased Gastrointestinal Bleeding Risk

The U.S. Food and Drug Administration (FDA) issued an updated statement on the possible side effects of Pradaxa, including an increased risk of stomach bleeding compared to warfarin.

In a drug safety communication issued on May 13, the FDA revealed that its new study shows Pradaxa has a higher risk of major gastrointestinal (GI) bleeding among and a similar risk of myocardial infarction with warfarin. The study analyzed information from more than 134,000 Medicare patients aged 65 years and older.

Pradaxa increased the risk of GI bleeding by 28 percent, the study found, with 34.2 GI bleeding incidents for every 1,000 person-years of use. That compares to 26.5 incidents for users of warfarin. The study also found that Pradaxa has 80 percent of the risk of stroke when compared to warfarin, and only had about one-third of the risk of brain bleeding.

“As a result of our latest findings, we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use,” the FDA said in a statement. “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.”

The agency said it continues to investigate the causes for the differences in major GI bleeding rates for Pradaxa and warfarin.

Boehringer Ingelheim’s Pradaxa and warfarin are blood thinner drugs used to reduce risk of stroke and blood clots in patients with abnormal heart rhythm labeled as non-valvular atrial fibrillation (AF). Since its approval in October 2010 through December 2013, about 6.2 million Pradaxa prescriptions were dispensed to 934,000 patients from U.S. outpatient retail pharmacies.

Pradaxa belongs to a class of drugs called blood thinners, or anticoagulants. These drugs are designed to dissolve blood clots and make it harder for blood clots to form. This can decrease a person’s risk of stroke, since strokes are situations in which blood clots form within the blood vessels and block the supply of fresh blood to the brain. However, all anticoagulants carry the risk of uncontrolled bleeding.

Join a Free Pradaxa Class Action Lawsuit Investigation

If you or a loved one were medically diagnosed with internal bleeding problems after using Pradaxa, you may be able to take legal action against the drug’s manufacturer. Joining a Pradaxa class action lawsuit or filing an individual Pradaxa lawsuit may help you recover compensation for medical bills, pain and suffering, and other damages. Obtain a free case evaluation now:

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