Pradaxa Manufacturing Lot Recalled Due to Defects, Patients Still at Risk for Pradaxa Side Effects
Boehringer Ingelheim, manufacturer of anti-coagulant drug Pradaxa, recalls a production lot of Pradaxa because of a defective bottle, but leaves thousands of patients still at risk for potentially deadly Pradaxa side effects. The company announced a recall of a manufacturing lot of 75 milligram Pradaxa capsules with the expiration date of January 2015. The company cited a defect in the drug’s packaging, which allows moisture to get into the bottle, reducing the drug’s effectiveness.
But while patients might be able to return defective packaging, they won’t be safe from Pradaxa side effects such as uncontrolled bleeding that may lead to serious complications and death. Pradaxa is used to reduce the risk of stroke and embolism in patients with atrial fibrillation. Although all blood-thinner drugs cause some risk of bleeding in patients, there is no antidote to Pradaxa’s anticoagulant qualities once the bleeding starts.
Between Pradaxa’s FDA approval and March 2011, the agency received 932 Pradaxa adverse events reports. As of the end of 2011, the FDA has received over 500 reports of Pradaxa related deaths. Health regulatory agencies in Australia, Japan and Europe have all issued warnings about Pradaxa bleeding side effects.
And a recent study suggests that the severe risks may not even bring much clinical improvement. A study published in The Archives of Internal Medicine found that Pradaxa and other blood thinner drugs were “no advantage over the placebo” in patients with acute coronary syndrome. Patients taking a blood thinner experienced a three-fold increased risk of excessive bleeding.
Patients who suffered from Pradaxa bleeding and other side effects are filing lawsuits to seek compensation for their expenses and injuries. The lawsuits allege that the manufacturer of the drug failed to adequately warn patients about the risks associated with the drug, and the lack of an antidote. To learn more, call 1-877-779-1414.