Pradaxa Manufacturers Kept Records from the FDA

Unsealed Court Documents Show Pradaxa Information Withheld from FDA

Unsealed court documents in a Pradaxa injury case show that the manufacturer, Boehringer Ingelheim GmbH did not disclose a data analysis to US regulators, which indicated that their blood thinner, which was touted as safer than their leading competitor warfarin, may have caused more fatal bleeding after it won approval.

According to the documents, Boehringer gave the FDA one analysis after Pradaxa was approved in October 2010, which showed the number of people who died from bleeding related to the blood thinner was less than expected. However, additional documents showed a higher bleeding and death rate, but those documents were not presented.

“Having run an analysis in several ways, there is no good reason not to disclose all the results,” said Harlan Krumholz, a Yale University cardiologist in New Haven, Connecticut.

However, company spokeswoman Marjorie Moeling said that the company gave the FDA the underlying data and provided an analysis using what the pharmaceutical company considered the most appropriate comparison. “The company is completely confident that all of the facts will show that Boehringer Ingelheim acted appropriately and responsibly,” she said.

One analysis, which the company presented, looked at deaths caused only by bleeding, and found 5.8 deaths per 10,000 patients on Pradaxa. The other study, however, examined deaths for any reason that involved major bleeding events, and found 19.5 fatal events per 10,000 patients.

In the deposition, unsealed on February 19th, prosecutors allege that 1,400 people at least have died from bleeding out after taking Pradaxa. There is also no “antidote” yet approved for use to counteract the drug – warfarin, which has been sold under the brand name Coumadin and in generic forms for nearly 50 years, has ways to counteract excessive bleeding.

The pharmaceutical manufacturer reported that, as of February 13th, the company faces 2,000 personal injury and wrongful death lawsuits related to Pradaxa. The cases are consolidated under MDL In re Pradaxa Products Liability Litigation, 12-MD-02385, U.S. District Court, Southern District of Illinois (East St. Louis).

The Strom Law Firm Can Help with Injury Cases Involving Pradaxa

If you or a loved one have been prescribed Pradaxa and have suffered any of these complications:

  • Fatigue,
  • Unusual bleeding & hemorrhaging,
  • Pink or brown urine,
  • Red or black stools,
  • Coughing blood,
  • Vomiting that resembles blood or looks like coffee grounds,
  • Bleeding from the gums,
  • Regular nosebleeds,
  • Joint pain & swelling,
  • Headaches,
  • Dizziness,
  • Weakness and swelling of the joints,
  • Intestinal bleeding, and even
  • Death.

You may have a personal injury or wrongful death case against Pradaxa’s manufacturers.

The pharmaceutical liability lawyers at The Strom Law Firm, LLC are at the forefront of the fight to protect the public and will stand up for your rights against the big drug and insurance companies. We will fight to ensure that you and your loved ones receive the justice you deserve.  Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. 803.252.4800



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