OpenFDA Promises Free, Open Access to Vital Health Data

On Monday, the U.S. Food and Drug Administration (FDA) launched a new initiative designed to give researchers and the public access to millions of reports involving problems associated with side effects of different drugs. is designed to allow researchers, industry, web developers and the public to easily access the FDA’s adverse event reporting system and other health databases. The move is part of an executive order by President Barack Obama to make government records more accessible to the public and to increase transparency.

The adverse event drug data includes 3 million documents dating back to 2004. The website, currently in beta, expects to add data on medical devices and foods in the near future.

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“These publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source,” said Taha A. Kass-Hout, M.D., chief health informatics officer and director of FDA’s Office of Informatics and Technology Innovation, in an FDA blog. “Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set — and others — to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives. But obtaining this information hasn’t always been easy.”

As presented, the database requires a high level of skill to use and to extract information. It is currently mostly useful to those familiar with JSON documents and API databases. However, the FDA says the data will allow software developers to create new applications, such as mobile phone apps and websites, that will allow the public easy access to the data. It also will eliminate the need for hundreds of Freedom of Information Act (FOIA) requests each year.

Data Helps Spot Drug Problems

A number of groups already mine the FDA adverse event data for information and provide analysis to the public, including the Institute for Safe Medication Practices (ISMP).

ISMP releases quarterly reports on trends in adverse drug events, and is often the first to note emerging safety problems with new medications or classes of drugs. The group was the first to warn of growing adverse event reports with the smoking cessation drug Chantix, and the blood thinner Pradaxa, for example. In both cases, the analysis preceded a wave of public concern over the drugs and product liability lawsuits against the drug makers for failing to adequately warn about potential risks.

Pradaxa (dabigatran) was first approved by the FDA in October 2010, for the prevention of strokes among patients with atrial fibrillation. It was the first in a new class of blood thinners designed to compete with warfarin, also known by the brand name Coumadin, which had dominated that market for decades.

Shortly after its release, ISMP noted that Pradaxa was racking up a large number of adverse event complaints by doctors and patients involving controllable bleeding and hemorrhages that could not be stopped. Unlike warfarin, whose anticoagulant effects can be reversed using vitamin K, Pradaxa had no reversal agent. That meant that doctors did not have a go-to technique to stop Pradaxa bleeding events.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced by Boehringer Ingelheim. ISMP tracked those thousands of Pradaxa adverse event reports, and rated the drug as the medication with the highest number of complaints to the FDA.

Ultimately, Boehringer Ingelheim faced about 4,000 Pradaxa bleeding lawsuits, and last month the company announced an agreement to settle the Pradaxa litigation for $650 million. The company is now also working on a Pradaxa reversal agent to help doctors control bleeding events.


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