Last month, DrugRisk reported that the popular atrial fibrillation blood thinner Pradaxa was facing tough times: a new study announced by the FDA, a growing number of lawsuits alleging the drug caused internal bleeding injury or death, and trials scheduled to start later this year.
Now, the resource center has learned that drug maker Boehringer Ingelheim’s own employees worried that an internal safety study might hurt drug sales and years of work if made public. Records show some may have even been pressured to stay quiet.
Pradaxa was introduced in 2010 as an alternative to warfarin to prevent clotting and strokes in patients with atrial fibrillation. Unlike warfarin, it doesn’t require regular blood tests or changes in diet. However, it also does not have an antidote to stop bleeding in emergencies.
Experts have warned new drugs like Pradaxa may raise bleeding risks by 55%, and that those suffering bleeding are almost 5 times as likely to die as those with bleeding from warfarin.
Regardless, Pradaxa has become a blockbuster, selling over $2 billion in the U.S.
Last month, Judge David Herndon, who oversees thousands of Pradaxa lawsuits in a special federal court, unsealed documents from Boehringer showing concern that an internal study found some patients may need regular blood testing for safety.
Company doctor Paul Reilly circulated a study indicating some patients may absorb too little Pradaxa, raising risks for blood clots and strokes, while others may absorb too much, raising risks for internal bleeding. This conflicted with the drug’s marketing claims that it wouldn’t require the same testing as warfarin.
Emails show Boehringer supervisors countered that the report could undo years of marketing claims, and that it should be presented in a different manner, although the public needed the information. Ultimately, Boehringer did not release the study.
Boehringer has already been fined almost $1 million by the federal court for concealing or failing to preserve crucial data needed for the trial.
The latest court records show 2,057 patients or families have filed a Pradaxa lawsuit over internal bleeding. Anyone affected should learn their legal options soon, as the first trials are scheduled to start in August.
If you or a loved one suffered internal bleeding after taking Pradaxa, it is important to speak with a lawyer. It costs nothing to discuss your case or file a claim unless you recover.
Due to the complex nature of these cases, DrugRisk only recommends lawyers specializing in Pradaxa lawsuits. Contact us today for more information or to speak with a lawyer.