Consumer Watchdog Says FDA’s Review of BI’s Blood Thinner Is Dangerous

A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous.

In an 80-page report released last week, the Project on Government Oversight questions the agency’s 2010 approval of Pradaxa (dabigatran) to prevent blood clots in patients with atrial fibrillation, noting that since its approval, it has been among the drugs most frequently named in adverse events reports — including nearly 2,000 reports about patient deaths, as of September 2012.

POGO points out that while the label includes fine print that Pradaxa can cause fatal bleeding and that there is no antidote, the FDA doesn’t require the label to carry a black box warning.

BI is conducting clinical trials on idarucizumab, a possible antidote, and recently reported an interim analysis showing it reverses Pradaxis’ anticlotting effect within minutes.

Other issues raised in POGO’s report include:

• The FDA approved Pradaxa on the basis of an unblinded trial;
• The agency redacted a key document in a way that protected Pradaxa’s image at the expense of informing the public; 
• After refusing to allow BI to claim Pradaxa was superior to warfarin, the FDA permitted the firm to make a stronger marketing claim; and
• For years, the FDA allowed BI to make another marketing claim that the agency eventually conceded was misleading.

The report calls on the FDA to reject drug applications based on seriously flawed trials, use black box warnings to explain that trials that form the basis of FDA approvals can have serious limitations in predicting how a drug will perform, and conduct more inspections of clinical investigators.

The FDA and BI could not be reached for comment. Read the report here: www.fdanews.com/10-16-15-pogo.pdf. — John Bechtel