New Pradaxa Contraindication Issued for Patients with Mechanical Heart Valves
Anticoagulant drug Pradaxa, which has been linked to serious Pradaxa side effects such as excessive bleeding, will be contraindicated for patients with mechanical heart valves.
Boehringer Ingelheim, the manufacturer of the blood thinner drug, will start sending out “Dear Doctor” letters, otherwise known as Direct Healthcare Professional Communication (DHPC), informing physicians that Pradaxa will now be contraindicated in patients with mechanical heart valves in accordance with a recent FDA decision.
The FDA decision follows a decision made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.
These actions are based on findings from the RE-ALIGN trial in patients with mechanical heart valves, which was prematurely stopped by Boehringer Ingelheim after an interim review of the trial data by the Data Safety Monitoring Board.
Pradaxa Bleeding: A Serious and Deadly Pradaxa Side Effect
Pradaxa is an anti-coagulant drug used to lower the risks of strokes and embolism in patients with atrial fibrillation introduced in 2010 as an alternative to blood-thinner drug warfarin, which had been on the market for decades. Pradaxa can also cause fatal, uncontrolled bleeding that cannot be reversed. The FDA has received more than 540 reports of Pradaxa deaths and 3,781 reports of Pradaxa side effects in 2011.
Pradaxa side effects are so devastating because there is no antidote for its blood-thinning properties. Competitor drug warfarin’s blood-letting effects can be stopped with administration of Vitamin K, but no such easy solution exists for Pradaxa. Health regulators in Australia, Japan and Europe have issued advisories about dangerous Pradaxa side effects.
Pradaxa Side Effects Lead to Increasing Pradaxa Lawsuits
Victims of Pradaxa bleeding and other side effects are filing lawsuits against the drug manufacturer to seek compensation for their injuries. Pradaxa lawsuits allege that the company failed to disclose the risks associated with the blood-thinner drug, especially the lack of an antidote, and that the company is responsible for patients’ injuries and deaths.
Approximately 120 Pradaxa lawsuits have been filed in federal court, a number that is expected to grow. If you took Pradaxa and suffered from excessive bleeding or other complications, speak to a lawyer today to learn more about how you may be entitled to compensation for your medical expenses, lost wages, pain and suffering, and more. Call (877) 779-1414 for a free and confidential case review.