Keeping score on the new warfarin-alternative drugs? Take note: Boehringer Ingelheim's Pradaxa has a new safety alert. The German drugmaker said patients about to start on the drug should have their kidney function checked, and patients aged 75 and older should have the same tests run annually. The update was triggered by some cases of severe bleeding, a company spokesman said.
Doctors were already warned against using Pradaxa in patients with severe kidney problems, Reuters reports. Boehringer agreed with European regulators that the advice should be broadened to call for new checks on all patients. If a patient's kidneys fall short of filtering Pradaxa's active ingredient from the bloodstream, the risk of severe bleeding increase.
The screening would be a new hurdle to Pradaxa treatment--and thus a potential disadvantage in its competition against Bayer's Xarelto, which is already marketed in Europe for one anti-clotting use and on the verge of gaining a crucial OK for stroke prevention. When Pfizer and Bristol-Myers Squibb's Eliquis hits the market, probably sometime next year, the fight for market share will only intensify.
- get the Reuters news