A new report from the Project on Government Oversight (POGO) includes serious criticisms of the FDA and the process through which it approved Pradaxa, Boehringer Ingelheim’s widely used, yet highly controversial anticoagulant drug. The comprehensive review of Pradaxa’s path to the American market accuses the regulatory agency of being “lax,... Read more »

Foreign regulators in Australia completed a review of a new class or oral anticoagulants – Xarelto, Pradaxa and Eliquis – finding little evidence to support the benefits of routine blood monitoring in patients. Prescriptions for these blood thinning medications have skyrocketed in recent years, primarily because of their dosing convenience, allowing... Read more »

Researchers at Johns Hopkins are suggesting that the use of two popular “new generation” blood thinners may run as much as twice the risk of gastrointestinal bleeding as the drug they are trying to replace. Despite recent research that has established that Pradaxa and Xarelto carry a significant increase in... Read more »

JAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public.... Read more »

An investigation by Deborah Cohen of the British Medical Journal (BMJ) has revealed that Pradaxa manufacturer Boehringer Ingelheim may have withheld analyses that might have prevented some Pradaxa bleeding events. Monitoring and dosing adjustments could make use of the drug even safer and more effective, according to Cohen’s findings. However, the... Read more »

In a statement issued on May 28, 2014, the pharmaceutical giant Boehringer Ingelheim announced that they had reached a settlement agreement with plaintiffs who filed lawsuits with regard to side effects from Pradaxa, a medication designed and manufactured by the company. The Pradaxa settlement involves a payout of $650 million,... Read more »

The FDA has released an updated statement on the Pradaxa stomach bleed risk, suggesting that patients taking the drug may have an increased risk of stomach bleeds, compared with warfarin. Pradaxa is a blood-thinning medication used to decrease the risk of stroke and blood clots in patients with non-valvular atrial... Read more »

With Pradaxa lawsuits on the rise, drug manufacturer Boehringer Ingelheim just suffered another public relations blow with a new report from the healthcare information company AdverseEvents. The company compared adverse events linked to three new anticoagulant drugs on the market today; finding Pradaxa and Xarelto fell far behind Eliquis in... Read more »