Pradaxa (Dabigatran) is a drug that’s used to help prevent strokes or intense blood clots in patients with atrial fibrillation, a condition in which the patient has irregular heart beat, without heart valve disease.
According to some sources, there have been a staggering number of reports involving hemorrhages among the users of the medication and it has been linked to hundreds of deaths. Although Pradaxa has been promoted as a superior medication because it requires less monitoring, internal bleeding problems cannot be reversed if they do occur. Users of the older, more widely-used blood thinner, Coumadin(Warfarin), bleeding events can be addressed by giving the patient a dose of Vitamin K.
Pradaxa continues to be a newsmaker in the pharmaceutical industry. As, the makers of Pradaxa have now been cited by a British regulatory agency for the way they provide Pradaxa information on the drug’s website, after an anonymous complaint led to the investigation. The charges were brought by an unidentified general practitioner, who began investigating after seeing a press release from the company that described the competing blood thinner, Warfarin, as “rat poison” and referred to Pradaxa as a “wonder drug.” It was found that Clause 4.6 of the Code had been breached because the site was found to be promoting Pradaxa but did not give a clear andprominent statement as to where the prescribing information can be found.
The citations come as the company and its new blood thinner are under close scrutiny from regulators in the United States, Europe, and Canada which have all launched investigations into Pradaxa health risks amid a number of post-marketing reports involving severe bleeding events and deaths.
The website violations have not yet been published in a report.[related_posts limit=”5″]