FDA Pradaxa Warning: What Should You Know?

On December 7, 2011, the blockbuster anticoagulant Pradaxa entered new territory when the U.S. Food and Drug Administration (FDA) announced that it would begin evaluating post-marketing reports of serious bleeding events in patients taking the popular drug. The manufacturer of Pradaxa, Boehringer Ingelheim, reportedly received 260 Pradaxa-related fatal bleeding events worldwide between March 2009 and October 2011, and the FDA has expressed concern over worries that the drug could be more dangerous than previously thought. This warning started the ball rolling on a series of studies, label changes, and lawsuits that collectively cautioned the popular blood thinner could cause deadly bleeding events.

What Did the FDA Warning Say?

The FDA announced that it would begin evaluating post-marketing reports of serious bleeding events in patients taking the popular drug.

The FDA released a statement saying that they are looking determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected. The FDA said that in a large clinical trial (18,000 patients) that compared Pradaxa with its predecessor warfarin, major bleeding events occurred at similar rates with the two drugs. The FDA recommended that Pradaxa (dabigatran etexilate mesylate) should continue to be taken by patients, but that healthcare professionals and patients alike should report any adverse effects to the agency.

Even before this FDA announcement, Pradaxa’s labeling already included a warning about significant and sometimes fatal bleeds. The FDA states that serious and fatal bleeding is a well-recognized complication of all anticoagulants. The agency advised patients to seek immediate care if developing any signs or symptoms of bleeding, such as:

• Bleeding from the gums
• Frequent nosebleeds
• Menstrual or vaginal bleeding that is heavier than normal
• Bleeding that is severe or uncontrollable
• Pink or brown urine
• Red or black tarry stools
• Bruises that happen without a known cause or ones that get larger
• Coughing up blood or blood clots
• Vomiting blood

Label Changes to Pradaxa

Label changes were made to Pradaxa just one month after the December warning. These label changes added multiple warnings, including lack of a specific reversal agent and a recommendation to discontinue Pradaxa in patients who develop acute renal failure and consider another treatment option. It is believed that it is impossible to stop bleeding complications in patients because there is no known effective reversal agent to counteract the blood-thinner. Therefore, people who experience bleeding events, especially the fall-prone elderly, are at a heightened risk of dying from an unstoppable bleed caused by Pradaxa use.