FDA’s Drug Approval for Pradaxa “Lax” Says Watchdog Group

A watchdog group has questioned the FDA’s approval process of the blood-thinning medication Pradaxa, noting numerous deaths and lawsuits that have occurred since the drug went on the market. After a detailed review of the approval of this drug, the FDA has been described as “lax” or “permissive” when it came to determining the safety of this drug for the general public.

The Project on Government Oversight (POGO) issued the report on October 15, listing numerous criticisms of the way in which the FDA handled the approval process and ongoing evaluation of this blockbuster drug manufactured by Boehringer Ingelheim. The report involved interviews with researchers and patients, as well as pages of public records summarizing the history of the drug. The authors of the report conclude that the FDA’s approval process leaves much to be desired in terms of standards for clinical trials and drug safety.

About Pradaxa

Report authors chose to focus on the approval process for Pradaxa in their assessment because of the high number of adverse events and lawsuits that have been linked to the blood-thinner. When Pradaxa was approved by the FDA in 2010, it was touted as a safe and convenient alternative to the older blood-thinning medication warfarin. Like warfarin, Pradaxa was marketed as an effective method for reducing the risk of stroke in people diagnosed with atrial fibrillation. Unlike warfarin, Pradaxa was not accompanied by dietary restrictions or the need for regular blood monitoring, making it an attractive option for patients and physicians alike.

However, another key difference between Pradaxa and warfarin was the lack of an antidote should a bleeding event occur. Patients that began bleeding on warfarin could be given vitamin K to quickly reverse the effects of the drug and stop the bleeding. No such substance exists to reverse the effects of Pradaxa, leading some patients to experience uncontrollable and deadly bleeding while on the drug.

Report Findings

As POGO reviewed the process by which Pradaxa was approved, the organization found a number of breaches in protocol by the FDA:

• Although Pradaxa posed the same bleeding risks as warfarin, Boehringer Ingelheim was not required by the FDA to place a black box warning on their product package. Warfarin does include such a warning.
• Approval was granted despite the knowledge there was no known antidote to counter the side effects of Pradaxa if a bleeding event should occur.
• Although reports of serious bleeding events with Pradaxa continued to surface, the FDA continued its public defense of the drug.
• The drug was approved by the agency based on a single clinical trial, without subsequent studies to confirm the findings of the first.
• The single trial performed was not “blinded,” which means researchers knew which patients were taking Pradaxa during the study. This knowledge could lead to a bias in the research findings, an issue the FDA chose not to address in this approval process.
• The FDA allowed Boehringer Ingelheim to make the claim that Pradaxa was superior to warfarin in product advertising, despite the fact that no clinical evidence supported such a claim.
• Members of the FDA that reviewed Pradaxa also had ties to the pharmaceutical industry. In fact, two of those committee members developed “substantial financial relationships” with Boehringer Ingelheim.

In the conclusion of the report, authors noted that in May 2014, Boehringer Ingelheim reached a settlement agreement for pending lawsuits totaling $650 million. At that time, the company stood by its product, even citing the FDA’s approval as a demonstration of the drug’s “positive benefit-risk profile.”

The authors of the report also listed recommendations to improve approval standards and prevent problems similar to those seen with the Pradaxa approval process. However, the report also notes that it is unlikely the FDA would be able to implement such changes without additional funding from the federal government.

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