FDA's Mini-Sentinel set to graduate on October 1

The FDA's Mini-Sentinel has long since outgrown its "mini" moniker and is now ready to graduate from being a pilot project to being an integral part of the agency's drug-safety infrastructure. Many people welcome the program's progress, but doubts and dissenting voices remain.

Nature News has reviewed the arguments for and against the system ahead of it dropping its pilot project status on October 1. The tool now pulls in information from the health records of 175 million people, giving the FDA the ability to ask drug-safety questions of a huge data set. The FDA's use of the data to probe the safety of Boehringer Ingelheim's Pradaxa is its highest profile case so far. And while the FDA was confident enough in the analysis to downplay the risks of Pradaxa, others have their doubts.

"I have no idea whether that drug is dangerous or not. But I sure as hell know that particular analysis didn't shed any light on the question," Columbia University's David Madigan told Nature News. Madigan takes issue with the way the FDA released an official statement saying the risk of bleeding from Pradaxa was similar to that of warfarin. After publishing the notice, the FDA acknowledged that its analysis overlooked potentially confounding factors, such as the possibility that Pradaxa was given to younger, healthier patients.

The team behind Mini-Sentinel claims it can now handle such analyses, positioning it to run more thorough evaluations of drugs in the future. Another unanswered question is how much value the FDA will assign to the data when considering it alongside traditional sources of safety reports.

- read Nature News' article

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