Pradaxa: The FDA’s Stance:

Approval of Pradaxa

Pradaxa (Dabigatran) is a blood-thinning drug which is prescribed to reduce the elevated risk of stroke among patients who suffer from heart valve problems or atrial fibrillation. Pradaxa (Dabigatran) is the first drug in its class to gain FDA approval in nearly sixty years, since the drug Warfarin—also known as Coumadin—was approved. Pradaxa, manufactured by Boehringer Ingelheim, received approval by the FDA in the fall of 2010, however in the relatively short amount of time in which doctors have been prescribing the drug there have emerged reports of serious side effects and even death.


About the Manufacturer

The Boehringer group is among the world’s two dozen leading pharmaceutical companies with headquarters in Ingelheim, Germany. Boehringer operates on a global basis with affiliates in fifty countries and more than 40,000 employees. Founded in 1885, Boehringer is a family-owned company who posted net sales of 12.7 billion dollars in 2009. The chairman of Boehringer, Andreas Barnes, proclaimed the approval of Pradaxa (Dabigatran) marked a new era for stroke prevention in those with atrial fibrillation as well as being an incredibly important even in the history of Boehringer.


Approval of Pradaxa (Dabigatran)

The initial approval of Pradaxa (Dabigatran) occurred in Europe in 2008 for use in the prevention of venous thromboembolism in those who had undergone hip or knee surgery. At that time the manufacturer stated that in the coming months Pradaxa (Dabigatran) would become available in more countries and to those with symptoms of atrial fibrillation. Boehringer sponsored the first random clinical trial on Pradaxa (Dabigatran) in late 2005, comparing its safety to that of Warfarin. This trial—which included over 18,000 patients in 44 countries who were considered to be at risk of stroke—concluded in early 2009 with seemingly positive results, and the FDA approved the drug in the fall of 2010.

In November of 2010, barely a month after Pradaxa (Dabigatran) received FDA approval, Boehringer Pharmaceuticals sent out a press release which announced Pradaxa (Dabigatran) would now be available to U.S. patients as a more effective alternative to Coumadin. The FDA issued a minor alert to patients in March, 2011, simply stating that Pradaxa (Dabigatran) should always be kept in its original package due to the potential of loss of potency should moisture be introduced. In August of 2011, less than a year after Pradaxa (Dabigatran) received FDA approval, Boehringer reported a sixty percent increase in overall net sales due to the launch of Pradaxa (Dabigatran) and two other drugs. U.S. pharmacies report dispensing over a million Pradaxa (Dabigatran) prescriptions in its first year, with nearly 400,000 patients receiving the drug.

Three months later the manufacturer of Pradaxa (Dabigatran) reported that over 250 deaths have been linked to the use of Pradaxa (Dabigatran), and in December the FDA announced a safety review of the drug, stating they would be evaluating reports of serious and fatal bleeding incidents among patients taking Pradaxa (Dabigatran). In January of this year a new study’s findings were published in a well-known medical journal suggesting there may be an increased risk of heart disease in patients taking both lower and higher dosages of Pradaxa (Dabigatran) as compared to Warfarin. Another report from the Institute for Safe Medication Practices was also released in January which evaluated negative reports and negative symptoms from those taking Prada which were submitted throughout the past twelve months.

By the second quarter after Pradaxa (Dabigatran) became available in America the FDA had received over 900 reports of serious negative effects involving Pradaxa (Dabigatran) including 120 deaths, the permanent disability of 25 people, and over 500 hospitalizations. Finally, just last month a study was published in the Journal of the American College of Cardiology which showed that Pradaxa (Dabigatran) definitely increased severe bleeding risks as compared to Warfarin—16% of those treated with Pradaxa (Dabigatran) experienced complications from bleeding or strokes as compared to 6% of the patients who received Warfarin.


No Recall in Sight

While the FDA has not yet issued a formal recall of the drug Pradaxa (Dabigatran) it has asked for an official safety review in response to the adverse health event reports as well as widespread reports of serious side effects and injuries. Any person taking Pradaxa (Dabigatran) who has experienced any negative side effects such as a feeling of lethargy, unusual bruising, severe or prolonged headaches, weakness or swelling in the limbs, coughing up or vomiting up blood, a pink or brown-tinged urine, bleeding from the gums or nose or unusual dizziness should immediately see their physician and should consider consulting with a personal injury attorney depending on the severity of their symptoms.


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