As Boehringer Ingelheim Pharmaceuticals Inc. faces Pradaxa lawsuits filed primarily on behalf of patients who suffered complications stemming from the blood thinner’s bleeding risk, the manufacturer Dec. 19 announced another change in Pradaxa’s U.S. prescribing information.
Based on interim findings of an overseas “study in patients with mechanical prosthetic heart valve replacement,” Boehringer Ingelheim added language to Pradaxa’s warnings and precautions advising that “patients with mechanical prosthetic heart valve replacement” not use the drug.
“Pradaxa has not been evaluated in the treatment of atrial fibrillation caused by heart valve problems and cannot be recommended in these patients. The use of Pradaxa has not been evaluated in patients with bioprosthetic valves and use cannot be recommended for such patients,” according to a corporate statement.
If only such prudence were exercised in regard to the increased risk of Pradaxa-induced bleeding, many patients might have been able to avert serious injury.
For instance, if there had been more careful reflection in the development of Pradaxa and in the FDA-approval process, ideally an antidote for Pradaxa bleeding would have existed and thus would have spared many of the 542 patients in 2011 whose deaths were linked to taking the blood thinner. That figure came from the nonprofit Institute for Safe Medication Practices, which analyzed adverse event reports submitted in 2011 to the FDA.
Pradaxa, just like the older anticoagulant warfarin, is “used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, the most common heart rhythm abnormality, which causes the heart to beat rapidly and irregularly,” according to a November 2012 FDA statement.
Since January 2012, the FDA-approved Pradaxa warning has read, in part, “Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.”
Someone who suffered bleeding after taking Pradaxa, in addition to the next-of-kin of someone who did not survive Pradaxa bleeding, may want to discuss his or her legal options with one of the experienced Pradaxa attorneys at Reich & Binstock. The consultation is free-of-charge.
The personal injury lawyers at Reich & Binstock, who operate nationwide, have devoted nearly 30 years of practice to pursuing the compensation to which damaged Pradaxa patients and other victims of pharmaceutical injury are entitled. Reich & Binstock may be reached toll-free at 1-866-LAW-2400. The firm’s Web site is www.reichandbinstock.com.