History of the FDA and Pradaxa

Pradaxa has been the subject of several FDA safety alerts ever since Boehringer Ingelheim introduced the blood thinning medication into the market. Based on adverse event reports submitted to the FDA and results from clinical studies, patients are at risk of suffering from serious Pradaxa side effects such as abnormal bleeding, heart attacks, embolism, strokes, and brain hemorrhages. Hundreds of Pradaxa lawsuits have been filed in federal and state courts as patients seek compensation for the injuries and economic losses they allegedly sustained as a direct result of using the drug.

FDA approval of Pradaxa

Pradaxa is a medication prescribed to patients with atrial fibrillation because it reduces the risk of them suffering from strokes and embolisms. On October 19, 2010, Pradaxa became the first oral anticoagulant to receive FDA approval in more than 50 years. Before Pradaxa became available, a drug known as warfarin was the only oral anticoagulation that reduced the risk of strokes in patients with atrial fibrillation.

Pradaxa received approval from the FDA based on a study called the RE-LY Clinical Trial that was conducted by Boehringer Ingelheim. The medical study compared Pradaxa to warfarin and analyzed the effects both drugs had on patients. According to the clinical trial results, patients who used Pradaxa had fewer strokes than patients who used warfarin, but Boehringer Ingelheim failed to disclose that Pradaxa didn’t have an antidote to reverse the anticoagulation effects.

Since an antidote doesn’t exist for Pradaxa, patients are at risk of suffering life-threatening injuries or death if they start to bleed abnormally. The original Pradaxa warning label failed to adequately disclose this information.

FDA safety alerts for Pradaxa

From October 2010 through June 2011, the FDA received at least 1,700 adverse event reports detailing the side effects sustained by patients who used Pradaxa. There was slightly more than 1,000 incidences of severe bleeding and 237 deaths linked to Pradaxa.

In July 2011, the Archives of Internal Medicine published a medical study that concluded elderly patients were at greater risk of suffering from Pradaxa side effects due to lower body weight, renal impairment, and adverse drug interactions.

On December 7, 2011, the FDA announced that it was evaluating post-marketing reports to determine if more patients are suffering from severe Pradaxa bleeding than expected based on the results of the RE-LY Clinical Trial. In spite of the information received in the adverse event reports, the agency stated that it still believed Pradaxa provided benefits to patients with atrial fibrillation. The FDA recommended that individuals consult with a physician if they wanted to stop using the blood thinner.

In November 2012, the FDA issued a safety alert notifying the public that the bleeding rates for Pradaxa weren’t any higher than the bleeding rates reported for warfarin. The evaluation was based on the FDA’s administrative data and insurance claims. The FDA stated that the number of bleeding incidences were consistent with results from the clinical trial Boehringer Ingelheim conducted. The agency also stated that it was going to continue investigating the medical complications linked to Pradaxa.

On December 19, 2012, the FDA announced another safety alert to warn the public that patients with mechanical prosthetic heart valves shouldn’t use Pradaxa.

Based on the results of a European clinical trial, patients with mechanical heart valves are more susceptible to blood clots, heart attacks, and strokes. After a valve surgery, patients who used Pradaxa were at greater risk of suffering from excessive bleeding than patients who used warfarin. The FDA recommended Pradaxa users with mechanical heart valves consult with their physicians to determine an appropriate alternative treatment.

Pradaxa black box warning

On April 30, 2013, Boehringer Ingelheim stated that Pradaxa will now carry a black box warning. The updated Pradaxa FDA warning labels advise patients that if they stop the treatment, it increases the risk of them suffering from strokes. The modified label will also include data showing the Pradaxa death rate is lower than the death rate for warfarin. The FDA continues to encourage patients and healthcare professionals to report any adverse reactions or Pradaxa side effects.