Pradaxa Information on Website Violates ABPI Code of Conduct: Report

The makers of Pradaxa have been cited by a British regulatory agency for the way they provide Pradaxa information on the drug’s website. 

The Prescripton Medicines Code of Practice Authority (PMCPA) has cited Boehringer Ingelheim’s Pradaxa website for violating industry codes of conduct. It also charged the company over issues related to a press release.

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.” The article also failed to properly warn about the bleeding side effecgs of Pradaxa, according to details of the violations released in a December report (PDF).

An investigation into the Pradaxa website led to the PMCPA’s ruling that the site violated the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. The website was supposed to be for medical professionals only, but complaints claimed that the site instead targeted public promotion of the drug. While the PMCPA disagreed with that claim, it did cite the drug maker for not indicating prominently where the prescribing information could be found. The website violations have not yet been published in a report.

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.

Pradaxa (dabigatran) is a relatively new blood thinner, which was introduced by Boehringer Ingelheim in the United States in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations.  However, there have been a staggering number of reports involving hemorrhages among users of the medication, including hundreds of deaths from Pradaxa.

Among users of the older, more widely-used blood thinner Coumadin, known generically as warfarin, bleeding events can be addressed by giving the patient a dose of Vitamin K. Although Pradaxa has been promoted as a superior medication because it requires less monitoring, internal bleeding problems can not be reversed if they do occur.

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

As information about Pradaxa bleeding problems has increased in recent months, a growing number consumers have filed a Pradaxa lawsuit against Boehringer Ingelheim, alleging that the drug maker failed to adequately research their medication or warn about the risk of serious and potentially life-threatening gastrointestinal bleeds or hemorrhages.