PRADAXA (DABIGATRAN EXTILATE) is approved in the United States for use in non-valvular Atrial Fibrillation (AFib). As of March 2012, the the U.S. Food & Drug Administration has not approved it for any other indication. Any other uses are “off-label” and prohibited under U.S. law. Given the foregoing, PRADAXA CASES have emerged in worldwide reports of over 260 deaths, as of November 2011. International scrutiny over these deaths, coincides with public health authorities in Europe, Australia, Japan and New Zealand alerting prescribers and patients about increased risks from use of the blood thinner.
Most recently, some authors have suggested that the dosing may hold a key to understanding adverse events. In the United States, PRADAXA (DABIGATRAN EXTILATE) is only available in 75 mg or 150 mg doses. This has been described in medical literature as a “low” and a “high” dose. As such, there is presently no intermediate or “medium”.
Reports of increased risk of heart attack or acute coronary syndrome have contributed to some raised level of awareness and concern. Estimates of 33% higher risk have been repeatedly cited. Comparable medicines were associated with similar risk ranging between 27% and 33%. An often cited article appeared in the Archives of Internal Medicine online edition. REUTERS reported on the article in a story by Bill Berkrot, on January 9, 2012, entitled “HEART ATTACK RISK SEEN WITH CLOT DRUG PRADAXA“. The REUTERS story quoted the authors as recommending that doctors “retain a critical view as a powerful drug enters clinical use on a potentially massive scale”, as well as additional investigation. A related editorial note cited Dr. Rita Redberg as providing that “[t]hese additional concerns deserve serious consideration in weighing the risks and benefits of dabigatran and highlight the importance of continued collective analysis of data after drug approval”. FDA’s adverse event reporting system is relied upon in the U.S. as the cornerstone for providing safety signals.
As the picture becomes clearer, and safety labels are strengthened to reflect risks, following only 2 years of availability in the U.S., some are questioning what risks were known and not adequately warned about when the product was launched in the U.S.. This will most likely be put in perspective as PRADAXA CASES are advanced through the U.S. civil justice system for survivors of adverse events.
PRADAXA CASES is sponsored by Gabriel F. Zambrano, P.A.. Gabriel F. Zambrano, P.A., is actively investigating cases involving serious personal injuries, deaths or disabilities from use of PRADAXA (DABIGATRAN EXTILATE) from October 2010 through the present date.