FDA Starts A Drug Safety Newsletter For Docs

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newspaper-boy.jpgThe quarterly publication, which debuted this afternoon, can be found on the main page of the FDA’s web site and will be sent by e-mail for free to anyone who subscribes. (Or you can click on this). Aimed at docs, the newsletter is being made available in response to a scathing Institute of Medicine report that found the agency is “dysfunctional.”

“The role of this newsletter is to keep our medical community posted–including physicians, dentists, nurses, and pharmacists–about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products,” FDA commish Andy von Eschenbach writes in the intro.

The inaugural issue contains post-marketing reviews of three drugs and ‘early safety findings’ concerning another, in this case, Exjade, a Novartis drug used to treat iron overload from blood transfusions. There’s also a list of safety advisories issued earlier this year.

For those concerned with safety (who isn’t?), this is a step in the right direction. More info is generally better than less info. And making it easy to find or obtain the newsletter is also useful. If there’s any quibbling it would be timeliness. A quarterly publication won’t be in a position to provide insights into the latest concerns. This first issue, for instance, has nothing about the recent FDA panel meetings held to review the safety of the EPO drugs or Trasylol. We tried repeatedly to reach an FDA spokeswoman to ask how this sort of scenario may be handled in the future, but there was no reply.

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  1. I vote yes. The truth needs to be out there for the public to be able to access.

  2. I vote yes.

  3. How can I sign up to get it monthly ?

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