On the surface, Pradaxa seems to have a lot of benefits that make it an ideal choice over its older cousin, Warfarin. But it hasn’t replaced Warfarin altogether because of the high rate of excessive bleeding that comes along with the drug.
Both drugs do have that risk. But Warfarin has countermeasures which Pradaxa lacks. And doctors can reduce the dosage for Warfarin patients to try to reduce the risks.
The FDA’s decisions did prevent Pradaxa users from pursuing a similar solution.
Even if a patient appears at higher risk of bleeding with Pradaxa, clinicians currently have no option for reducing the dose. In most advanced countries, in addition to the available 150 mg strength, there’s a 110 mg dose available, and recommended for use in patients age 80 and over and those with risk factors. But the FDA disallowed this lower dose here. A 75 mg dose has been approved, but only for use in patients with severe kidney disease.
An additional perspective on this safety problem recently emerged with two studies published in the American Journal of Cardiology and documents reported in the news media. These found that in many older patients, the lower 110 mg dose of Pradaxa is just as effective as the higher dose, but lowered the bleeding risk.
The lower dose is available in other countries, so why is the FDA dragging its feet on this? It’s not like Canada, Australia, and European nations are ignorant backwaters whose medicine can’t be trusted.
What do you think? Do you think the FDA is in the wrong here, or is there reason for caution?
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The lower dosage approved by the FDA is used for older patients as well as those with kidney issues. In fact, the FDA’s modeling showed the 75 mg dosage to be a better choice than the 110 mg dosage for patients that needed a lower dosage.
Mellanie True Hills
Thanks for the clarification, Mellanie!