FDA Investigating Serious Bleeding Events with Dabigatra
The FDA is investigating serious bleeding events with the anticoagulant dabigatran (marketed as Pradaxa) but maintains that for now, the drug's benefits "continue to exceed the potential risks" when it is used according to the prescribing information.
The agency says that while "even fatal" bleeding events have been reported since dabigatran was approved for reducing risks for stroke in patients with nonvalvular atrial fibrillation, it remains to be seen whether the rate is higher than would be expected.
Providers should continue prescribing the drug according to its approved label, the FDA says.Coming soon.
Comment: Why does the FDA continue to approve drugs, then find problems with them after they are on the market and result in either health issues or death?