Medical Journal Blasts Pradaxa Manufacturer for Marketing Practices
The British Medical Journal published a scathing report of Pradaxa manufacturer Boehringer Ingelheim’s marketing practices, with four reports suggesting that the drug company intentionally withheld important safety data on the blood thinner.
According to the report in the journal, Pradaxa manufacturer did not share its own internal analysis of the drug’s safety with either US or EU regulators. The internal studies suggested that Pradaxa can be safe if carefully monitored by plasma-level monitoring. However, the pharmaceutical company failed to inform regulators when Pradaxa went for approval.
“Regulators should recommend plasma level testing in all new patients, and eliminate the recommendation dabigatran [generic Pradaxa] does not in general require routine anticoagulant monitoring,” the authors write.
Other blood thinners such as warfarin use routine INR testing to monitor changes in clotting agents in order to keep patients safe from either potential bleeding incidents, or blood clots.
Pradaxa reports also showed “a potentially higher bleeding risk with dabigatran than has been stated” at phase 3 of its trials. However, the high bleeding risk associated with Pradaxa can be greatly reduced with monitoring: specifically, the company’s internal studies showed that monitored dosing “has the potential to provide patients an even better efficacy and safety profile than fixed-dose dabigatran and also a better safety and efficacy profile than a matched warfarin group.”
In response to the BMJ’s article about Pradaxa, Boehringer Ingelheim released a statement: “British Medical Journal publishes biased article regarding Pradaxa … Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating Pradaxa’s benefits and safety, and FDA and EMA have affirmed RE-LY’s conclusions. BMJ was provided this information by Boehringer Ingelheim but chose not to include it.”
The statement continued to say that the company is “concerned that this publication may alarm patients and prompt them to stop taking Pradaxa, thereby increasing their risk of stroke.”
A recent FDA study of 134,000 Medicare patients suggested that Pradaxa has no higher incident of stroke or brain bleeds leading to death than warfarin blood thinners, but the drug is correlated with a higher risk of gastrointestinal bleeding.
The study’s authors recommended that European regulators and the FDA approve a lower dose of Pradaxa than currently recommended. A lower dose could help reduce bleeding incidents associated with Pradaxa.
In July, a class action lawsuit filed in the British Columbia supreme court alleges that the potential for serious Pradaxa side effects was not properly disclosed on the label.
The Strom Law Firm Can Help with Injury Cases Involving Pradaxa
If you or a loved one have been prescribed Pradaxa and suffered any of the following Pradaxa side effects:
- 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 if you had serious outcome from Pradaxa side effects. 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
