Every medication has its positive and negative effects, you and the doctor just have to weigh the pros and cons and determine whether the risks are worth taking. This has been the case for Pradaxa, an anti-clotting medication aimed to avoid strokes on patients suffering from heart conditions. Although it has some considerable positive effects to patients’ health and wellbeing, Pradaxa has been linked to major health risks and complications that can make it more risky than beneficial to some patients.

Pradaxa (dabigatran) was approved by the Food and Drugs Administration in 2010 and was made an alternative to warfarin. It offered a good option because unlike warfarin, those taking Pradaxa did not require constant monitoring and check-ups. However, in just two years after its release, Pradaxa has been linked to 500 deaths, mainly due to uncontrollable bleeding and internal hemorrhage. Furthermore, more than 4,000 claims (and counting) have been and are being settled due to other severe side effects such as stomach pains and severe vomiting or heartburn. What makes the dangers of Pradaxa more troubling is that it does not have an antidote, which made uncontrollable bleeding a life-threatening side effect.

Despite the rising number of lawsuits being filed against them, the FDA has yet to issue a product recall for Pradaxa. The manufacturer of Pradaxa, Boehringer Ingelheim, has voluntarily issued a recall only on a specific lot due to concerns of manufacturing defects. The FDA only stated that they are continuing their evaluation of various data sources regarding the ongoing safety review of the drug. Although Pradaxa does provide great benefits, the risk of bleeding and hemorrhaging should be considered, especially for those who are elderly and people who might get surgery. Convenience may what Pradaxa offers, but in cases of accidents or emergencies any emergency procedures may be hindered because of the blood flow. Before taking Pradaxa, it is important to talk with your doctor to weigh the benefits and risks that come with the drug.