FDA Refuses to Recall Dangerous Drug
Once again, the FDA has agreed to let a drug stay on the market, even though evidence indicates the drug isn't in the best interest of the patients who take it. The drug is Pradaxa® (dabigatran), an anticoagulant used to treat nonvalvular atrial fibrillation and to prevent strokes.
Pradaxa is an alternative to warfarin, since Pradaxa requires less monitoring, blood tests and dietary restrictions. In clinical trials, Pradaxa worked better than warfarin in reducing stroke risk. It appeared to be safer, causing less hemorrhaging, at least in studies. When Pradaxa was approved two years ago, however, it wasn't the safe drug trials claimed it was. In 2011, it caused 542 people to bleed to death.
FDA claims that Pradaxa's bleeding rates "do not appear to be higher" than warfarin's. Yet, elsewhere on the agency's website, it states that the risk of bleeding from Pradaxa is six times greater than with warfarin and the bleeding usually occurs in a pericardial location.
Warfarin itself is dangerous. But if a patient starts hemorrhaging, vitamin K serves as an antidote to warfarin's blood-thinning effects. With Pradaxa, there is no antidote. This means that, in the event of a hemorrhage, the patient will bleed to death. In fact, of the more than 800 drugs monitored by the Institute for Safe Medication Practices, Pradaxa has resulted in more reports of injury or death.
So why did the initial trials find that Pradaxa causes less hemorrhaging than warfarin when it actually causes six times more? Could this have something to do with the fact the drug companies stood to gain a lot of money by releasing Pradaxa? In fact, Pradaxa now earns more than $1 billion in sales each year. Study results can, after all, be manipulated to benefit drug manufacturers.
Despite the dangers of Pradaxa, the FDA has refused to recall the drug. More than 100 lawsuits have already been filed and 1,000 more are expected, including a mass joint claim against Pradaxa's manufacturer.
Since warfarin is effective, there was no urgent reason why the FDA had to approve Pradaxa. There are also plenty of safe, natural ways to optimize the body's clotting system, including omega-3 fatty acids, ginkgo, garlic and nattokinase.
Once again, the FDA appears to be choosing the well-being of the drug companies over the health of patients.
Irfan Qureshi, ND
CP Chief Regulatory Officer