While the Food and Drug Administration is continuing to review increasing numbers of reports of serious internal bleeding risks associated with the blood-thinner Pradaxa, the agency has issued another safety alert warning about new concerns involving the medication.
The most recent announcement from the federal regulatory agency informs health care professionals and the public that the blood thinner should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
The FDA said it was making the announcement following startling developments in a clinical trial in Europe (the RE-ALIGN trial), which was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin.
FDA officials said that there was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. The FDA said Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.
Pradaxa (dabigatran etexilate mesylate) has become one of the most popular blood-thinners designed to prevent strokes since it was approved for consumer use by the FDA in 2010.
Although Pradaxa has been effective in preventing heart attacks and strokes in some patients it also has been the subject of numerous Pradaxa lawsuits in which victims claim that serious bleeding problems caused by the drug has led to kidney, brain, gastrointestinal bleeding and heart attacks and deaths.
There apparently are an increasingly large number of victims of these Pradaxa bleeding lawsuits because so many have been filed that a huge number have been consolidated before a judge who is overseeing pre-trial evidence gathering and settlement talks.
This litigation has not been finalized, however, and free consultations are still being offered for victims by Pradaxa lawyers. There may be legal time limits in such cases, so victims are encouraged to make contact as soon as possible for a free consultation in which their full legal options to seek compensation may be analyzed.
There have been disturbing reports of serious health problems that in some cases have proven fatal. Many Pradaxa users who take the medication to prevent strokes are reporting serious negative side effects such as severe internal bleeding, kidney problems and brain hemorrhages. These are among the allegations contained in Pradaxa lawsuits.