FDA Highlights Xarelto Risks Post-Pradaxa Warning

The Institute for Safe Medicine Practices issued a warning for the blood thinner Xarelto at the beginning of October. The ISMP cited a higher than expected risk of blood clots associated with the medication, and the warning come shortly after one that the FDA issued about a similar blood thinner, Pradaxa. However, unlike Xarelto, the side effects associated with Pradaxa include unstoppable internal bleeding and hemorrhaging. Although the medications are similar, their side effects are fairly distinct.

Pradaxa warning highlights side effects

Pradaxa and Xarelto are similar medications, both part of a class of blood thinners known as direct thrombin inhibitors. Pradaxa was the first drug of this class to hit the market when it was released in 2010, and Xarelto followed shortly in July of 2011, after which it was quickly associated with severe blood clots. At least 356 adverse effects reports associated with Xarelto were received during the first quarter of 2012, which is more than twice the number of reports submitted in the last quarter of 2011. At least half of these reports involve patients who are under the age of 66 who are complaining of serious blood clots.

In contrast, Pradaxa has mostly been associated with excessive internal bleeding and hemorrhaging, which can happen when the blood is unable to clot. The FDA issued a safety communication in 2011 about these side effects, which have even been linked to Pradaxa related deaths. Although the incidences of Pradaxa bleeding have been shown to be similar to those associated with an older anticoagulant, known as warfarin, the difference here is that there is no way to reverse Pradaxa bleeding, whereas vitamin K is an effective treatment for warfarin bleeding.

Plaintiffs seek compensation

Patients who have experienced side effects of Pradaxa often choose to file suit against drug maker Bayer, claiming that Bayer did not adequately warn them of the serious side effects of the medication. Many of these suits have been consolidated in federal multidistrict litigation in an effort to quickly and effectively resolve many cases against the same defendant.

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