Although Boehringer Ingelheim, the maker of the new blood thinner Pradaxa, has attempted to suggest that the number of individuals who have experienced severe bleeding on their medication is in-line with other blood thinners, a recent report from a drug watchdog group highlights how serious and potientially life-threatening Pradaxa problems are not as rare as the drug maker would hope people believe.
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Last month, the Institute for Safe Medication Practices (ISMP) released a report that evaluated serious, disabling and fatal adverse drug events reported to the FDA by drug manufacturers and the public through the agency’s MedWatch program. The results regarding Pradaxa are alarming, to say the least, especially since the drug was just introduced in October 2010.
During the first quarter of 2011, the FDA received at least 932 reports involving problems with Pradaxa, including 120 deaths. At least 505 of the adverse event reports involved hemorrhage, or bleeding, which far exceeded the number of bleeding problems reported in association with any other medication monitored by the ISMP report.
The medication with the second largest number of reported bleeding events was warfarin, or Coumadin, which was associated with 176 cases of hemorrhage. However, Pradaxa has been promoted as a superior alternative to the older, and more widely used warfarin.
Most of the problems with Pradaxa were reported among elderly patients, with a median age of 80, raising serious concerns about whether Boehringer Ingelheim is providing adequate warnings about the safe dosing and monitoring required for older patients.
The ISMP report also raised concerns about the current Pradaxa warnings regarding safe doses for those with moderate renal impairment or kidney function. While the current Pradaxa package inserts only recommend that dosage adjustments be made in cases of “severe” renal impairment, where a 75mg dose is recommended instead of the standard Pradaxa 150mg dose. However, the group points out that research suggests that while individuals with mild renal impairment have blood levels of Pradaxa that are 50% higher than those with normal kidney function, those with even moderately impaired renal function may have 3 times higher blood levels with Pradaxa.