News & Resources

June 25, 2012. Category: Unsafe Drugs

Pradaxa Leads Country in FDA Safety Reports

According to the Institute for Safe Medication Practices' QuarterWatch, the FDA received more safety reports about Pradaxa (dabigatran) than any other drug in the year 2011. Pradaxa is a blood thinner prescribed to prevent strokes and blood clots in people of who have atrial fibrillation (AFib) without valvular heart disease. This medication was released in October of 2010 and was marketed as an alternative to older anti-coagulatants such as Coumadin and Warfarin. Pradaxa's key selling point is that it does not require frequent lab monitoring.

Since it's release to the public, Pradaxa had more adverse events overall than any other drug in 2011. The medication was linked to 542 reported patient deaths. The number of reports for hemorrhage (2,367 cases), acute renal failure (291 cases), and stroke (644 cases) caused by Pradaxa exceeded all drugs regularly monitored by the ISMP. There were also 15 reports of liver failure.

This is not the first time that Pradaxa has come under intense scrutiny for failure to adequately protect patients' safety. The FDA received over 300 serious Adverse Event Reports related to bleeding or clotting events within its first three months on the market in the U.S. In addition, in January 2012, doctors from the Cleveland clinic released results of a meta-analysis showing that Pradaxa increased the risk of heart attack from 27-33%. A March 6, 2012 report by the Journal of Neurosurgery detailed complaints by neurologists that once Pradaxa causes internal bleeding in a patient, there are no effective reversal agents to neutralize the drug's adverse effects.

Given all of this information, serious consideration needs to be given as to whether this drug is safe. It is crucial that patients discuss the potential risks of taking this medication with their medical professional as compared to other older anti-coagulant medications.

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