Doctors in Europe will be informed that certain patients should undergo kidney testing before they begin taking the anti-clotting medication, <"http://www.yourlawyer.com/topics/overview/Pradaxa-Internal-Bleeding-Hemorrhaging-Side-Effects-Lawsuit">Pradaxa. Boehringer Ingelheim, the maker of Pradaxa, will also notify European doctors that patients older than 75 and those with renal impairment should undergo kidney checks every year.
Pradaxa is approved to prevent strokes in people with atrial fibrillation. According to Reuters, it is one of a number of new anti-blood-clotting pills expected to replace warfarin.
According to a report from MedScape, because Pradaxa is excreted through the kidneys, impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding. Boehringer Ingelheim said in a statement that it had agreed that renal function testing was necessary under an agreement with the European Union’s top drug regulator, the European Medicines Agency.
“While on treatment, renal function should be assessed in clinical situations where a decline in renal function is suspected (e.g. hypovolemia, dehydration, and with certain co-medications),” a statement from the EMA said. “In patients older than 75 or with renal impairment, renal function should be assessed at least yearly whilst on treatment. Given Pradaxa is mainly excreted renally, the treatment should not be prescribed to patients with severe renal impairment (creatinine clearance less than 30 ml/min).”
This is just the latest safety issue to arise around Pradaxa. In August, regulators in Japan â€“ where the drug is sold as Prazaxa â€“ told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 of the almost 64,000 mainly elderly patients taking it there suffered heavy bleeding. According to Reuters, five of those patients died
In New Zealand, 122 cases of side effects in Pradaxa patients have been reported to the Centre for Adverse Reactions Monitoring (CARM), of which two out of five involved bleeding. As of a month ago, CARM had been alerted to four deaths; however, it said none were caused by Pradaxa. A CARM official said the agency was aware of nine cases of avoidable bleeding that may have stemmed from a too-rapid introduction of Pradaxa following warfarin treatment, or because the victims had inadequate kidney function.
Most recently the Institute for Safe Medication Practices (ISMP) reported since its U.S. approval in October 2010, Pradaxa has been named in more U.S. Food & Drug Administration (FDA) adverse event reports than over 98% of the medications the group monitors. According to the ISMP, within 12 weeks of the approval, Pradaxa was the suspect drug in 307 reported serious adverse events reported to the FDA. It outpaced most other drugs, including warfarin, the blood thinner Pradaxa was meant to replace. Most of the adverse event reports involved serious bleeding or blood clots in the elderly.
The ISMP also reported that Pradaxa is already being used off-label extensively, as only a third of U.S. prescriptions written since its approval have been for the FDA-approved indication.