FDA Investigating Pradaxa Bleeding Side Effects

The blood thinner Pradaxa has come under investigation by federal regulators, after the drug has been linked to as many as 50 deaths due to bleeding problems in only about one year on the market. 

The FDA issued a Pradaxa drug safety communication on December 7, indicating that it is now evaluating post-marketing reports of serious bleeding events linked to Pradaxa side effects.

The investigation comes about a month after Boehringer Ingelheim, the drug’s manufacturer, announced it was investigating the Pradaxa deaths.

There has been growing alarm among experts about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, mostly related to bleeding events in elderly patients.

The FDA says it will work with Boehringer Ingelheim to investigate the drug and go over post-marketing reports, but also notes that bleeding events are a known danger and side effect of blood thinners. The agency will look to see if there is anything abnormal about the side effects of Pradaxa that could be an unreasonable risk to consumers.

Pradaxa (dabigatran) was only released in October 2010, but has received more consumer complaints to the FDA’s MedWatch adverse event reporting system than 98.7% of the other drugs on the market. The drug is meant to be a replacement for warfarin and is supposedly easier to use and requires less monitoring, but warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs. There is no such quick fix for a bleeding problem with Pradaxa. It is a problem shared by all of the newest generation of blood thinners, which also includes Xarelto, Eliquis and Lixiana.

Some patients and doctors report that the drug sometimes has too much of an effect on clotting, leading to hemorrhages. Other reports indicate that at times it does not have enough of an effect, resulting in pulmonary embolism or deep vein thrombosis.

Currently, the FDA’s position is that Pradaxa provides an important health benefit. However, the agency also warned patients to immediately contact their health care provider if they see signs of bleeding problems, including: 

• Unusual bleeding from the gums
• Frequent nose bleeds
• Unusually heavy menstrual or vaginal bleeding
• Severe, uncontrolled bleeding
• Pink or brown urine
• Red or black stool that looks like tar
• Unexplained bruises that grow over time
• Coughing up blood or blood clots
• Vomiting blood or a substance that looks like coffee grounds