Boehringer Ingelheim Responds To Pradaxa Accusations
Boehringer Ingelheim has issued a response to recent media coverage concerning accusations that it did not give FDA complete data regarding its blood thinner drug Pradaxa. The company currently faces more than 2,000 injury lawsuits over the drug.
In its press release, the company insisted it provided regulatory authorities the required information for the product’s approval. “We have provided global regulatory authorities with complete data packages and full responses to requests for information about the research, development, testing, safety and efficacy of Pradaxa (dabigatran etexilate mesylate).”
Pradaxa capsules are indicated for the reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The company said the FDA approval of Pradaxa was based on an established safety and efficacy profile following review of all clinical data. Boehringer Ingelheim also said it continues to receive and report global data on adverse events to the FDA and other global regulatory authorities on an ongoing basis.
“Recent media coverage has chosen to take select fragments of documents out of context to inaccurately and incompletely characterize Boehringer Ingelheim and this medication. This media coverage is an attempt to sway public opinion in litigation outside of the courtroom.” This could potentially compromise health and safety of patients who may benefit from Pradaxa or similar medications to reduce risk of stroke, Boehringer Ingelheim stated.
The Germany-based company warned patients should not stop taking anticoagulant medication without advice from healthcare providers, as this increases risk of stroke. Its product carries a warning that patients discontinuing anticoagulation with Pradaxa for reasons other than pathological bleeding should consider coverage with a similar medication to avoid increased risk of thrombotic events.
“Boehringer Ingelheim stands behind Pradaxa. We are confident the facts will show that Boehringer Ingelheim and its employees acted appropriately and responsibly,” the company concluded in its press release.