About 2 million people take blood thinners and the latest and greatest anti-coagulant, Pradaxa, was hailed as a breakthrough for patients when it was approved by the U.S. Food and Drug Administration (FDA) in October 2010.
At first its major advantage over competitor Coumadin (warfarin in generic form), was that patients didn’t have to go in for the regular blood tests to measure their blood’s clotting ability.
Valuable, time saving convenience? Perhaps.
Then came the bad news. Just 15 months after its approval, a study out of the Cleveland Clinic found an increased risk of heart attack among those taking Pradaxa.
Then there’s the uncontrolled bleeding.
In March, an elderly man died of a brain hemorrhage after a minor fall. In December, a San Antonio woman bled out at her kitchen table after a minor bump. Her daughter found her in a pool of blood. The drug maker, Boehringer Ingelheim, has collected 260 reports of death due to uncontrolled bleeding among those taking Pradaxa.
Warfarin, the generic name of Coumadin, was approved in 1954 and originally developed as a rat poison. Rats would bleed out to their death when overdosed with Warfarin. But there is an established and safe protocol for Coumadin. Also, there is an antidote to Coumadin – Vitamin K will reverse it anticoagulation properties, so will dialysis. Not so for Pradaxa.
So what is the FDA to do?
Patients deserve enough information to make an informed decision. Who will choose the convenience of a drug with the possibility of bleeding out after simply banging your head? Some might, but it is their choice, after a complete and full disclosure.
Europe and Japan want Boehringer Ingelheim to put a warning on the label for Pradaxa but in the U.S. the FDA is reviewing the drug. At the present time, the label does not say there is no effective reversal agent to uncontrolled bleeding.
Meanwhile warfarin, originally developed as a rat poison because it caused the rats to bleed out, has been around for 50 years and remains the top anticoagulant drug prescribed with about 31 million prescriptions written a year.
Boehringer Ingelheim, the German drugmaker, would like to make some inroads so just last week they cut the price of Pradaxa by 13 percent in the United Kingdom to make it “as affordable as possible in this tough financial climate.” The price cut will make National Health Service patients in England and Wales eligible to receive the discount drug – about 900,000 patients in all. That’s a lot of Pradaxa if the company is successful. I wouldn’t be surprised if we see aggressive marketing, direct-to-customer ads, and price cuts in the U.S. to drive patients to Pradaxa.
All that could stand in the way of a rush to Pradaxa is information provided to patients on the drug’s label?