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Sep18
FDA Using Novel & Tried & True Techniques To Investigate & Publicize Adverse Events

I came across three announcements recently indicating that the FDA is starting towatchdog.jpeg utilize new and traditional resources to investigate and publicize adverse events.  The first has to do with Sermo, which – contrary to some predictions – is becoming a major force in health today.  

According to a Sermo press release the company “has entered into an evaluation agreement with the U.S. Food and Drug Administration (FDA) to allow the FDA/Center for Devices and Radiological Health (CDRH) to access Sermo’s online physician community. . . . For the next six months, the FDA will be monitoring the information from the Sermo community and utilizing Sermo’s underlying aggregation system for evaluating physicians’ clinical observations.”

Now the Sermo press release does not indicate that the agency will be looking at adverse event reports, but given that FDA is very interested in revamping its post-marketing surveillance efforts, I wouldn’t be surprised if it wasn’t evaluating Sermo’s utility in this regard.  

In addition, FDA has launched a major study to determine if there is a link between ADHD medications and increased heart problems.  This is the first research looking at all currently available drugs used for the treatment of ADHD.  

Finally, the agency announced today that it is releasing a new publication, Drug Safety Newsletter.  According to FDA the newsletter “is intended to complement other FDA methods of communicating drug safety information to the public. FDA also hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.”

Stung by allegations that the agency is too quick to approve medications, but slow to investigate their potential risks, it is clear that the FDA is taking steps to bulk up its adverse event monitoring and reporting procedures.

 


2 Comments/Trackbacks




You should check out iGuard.org, a self-learning initiative that offers risk ratings for drugs (ie. Lipitor is blue, prednisone is orange) together with personalized alerts and updates. My pharmacist directed me to it last week, and it seems miles ahead of anything you're reporting that the FDA is doing.

As long as the FDA is scared to tread on toes, I think that the private sector will surely trump the FDA in the Web 2.0 space.

Thanks for the link Akele62, thats a good site.

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