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LATEST FROM THE FDA REGARDING PRADAXA

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LATEST FROM THE FDA REGARDING PRADAXA

After Pradaxa gained the infamous distinction of being the most deadly drug of 2011, the FDA vowed to investigate its safety further.  On November 2, the FDA released a Drug Safety Communication explaining that the bleeding rates associated with Pradaxa use are not any higher than with warfarin use.

Pradaxa is the first alternative to warfarin to come on to the market in decades.  Both drugs are used to prevent strokes and atrial fibrillation.  However, Pradaxa seemed to be causing many more problems than warfarin had, becoming the drug with the most adverse events reported to the FDA in 2011.

But now the FDA is reporting that Pradaxa is just as safe as warfarin.  If this is true, why has Pradaxa created so many problems?  There are several reasons.

First, warfarin has to be monitored very carefully by doctors, but Pradaxa does not require such careful monitoring.  When Pradaxa is taken exactly right, it has higher safety rates.  However, this does not account for the fact that many patients aren’t as meticulous when they take their medications, and any variations can result in serious bleeding events.

Which brings us to the second problem with Pradaxa.  While warfarin has a reversal agent that doctors can use in case of a serious bleeding event, Pradaxa does not.  Therefore if a patient does end up with internal bleeding, there might not be much that doctors can do.

Lastly, these problems can be exacerbated in patients who have problems with their kidney functions, and until problems with the drugs began mounting, doctors hadn’t consistently been testing patients for compromised kidney function before prescribing Pradaxa.  If you suspect you might be in this category and haven’t talked to your doctor about it, you should.

This latest news about Pradaxa may seem like good news, and in a modest measure, it is good news for patients who take this drug.  However it should not lull patients into a false sense of security—there are still plenty of reasons that Pradaxa may ultimately be more risky than warfarin.

Further Reading:

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm282820.htm