Numerous patients have reportedly suffered from adverse Pradaxa side effects after taking the anticoagulant medication.

Pradaxa (dabigatran) is prescribed to treat and prevent the risks of strokes and blood clots in patients. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2010. Since then, it has been linked to a multitude of serious and life-threatening side effects. Pradaxa side effects reportedly included internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, and death.

A Pradaxa internal bleeding class action investigation is actively investigating patients who have suffered from Pradaxa side effects.

Pradaxa Side Effects

Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals and is considered a relatively new anticoagulant on the market. It belongs to a class of drugs known as Direct Thrombin Inhibitors, which act as anticoagulants that inhibit the thrombin enzyme.

After its initial approval by the FDA in 2010, the drug was marketed to be superior to the older, more traditional anticoagulant Coumadin, also known as warfarin. Patients taking warfarin are required to undergo constant monitoring and dosage evaluations, while Pradaxa merely requires the patient to take a single steady dose. A prescription for Pradaxa also does not require a change in a patient’s diet.

The downside of Pradaxa was its lack of a reversal agent, which was not made available to patients until Oct. 16, 2015, five years after Pradaxa hit the market. In comparison, warfarin has always had a reversal agent. Those taking warfarin who need to counteract the drug’s anticoagulant effect can do so by administering vitamin K. This could prevent continuous abdominal bleeding side effects that could result from taking the medication.

Prior to the availability of a Pradaxa reversal agent, there was no available antidote that could stop a patient’s uncontrolled bleeding until Pradaxa was flushed out of the body via dialysis. The technique of flushing the body of Pradaxa via dialysis can take hours and may result in multiple blood transfusions.

The FDA received 307 adverse reports filed by patients within the first three months after Pradaxa’s approval. The adverse event reports consisted of patients suffering from internal bleeding complications and other serious injuries.

According to the FDA, there were also more than 260 reported deaths from Pradaxa internal bleeding side effects. In 2011, the FDA released a safety and warning announcement cautioning Pradaxa users of the serious risk of uncontrollable bleeding. Symptoms of internal bleeding may include bleeding from the gums, red or black stools, vomiting blood, coughing up blood, and frequent nosebleeds.

Patients who suffered from Pradaxa side effects may be able to bring a lawsuit against the manufacturers of Pradaxa.  Successful plaintiffs may recover monetary damages for their past and future medical bills as well as for the pain and suffering they experienced after taking the medication.