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Pharma, FDA to study adverse events

By admin
Created Sep 27 2007 - 6:59am

When it comes to predicting who'll suffer severe drug side effects, seven heads are better than one. Such is the hope of a Big Pharma consortium formed to track down genetic risk factors for serious adverse events.

The group--which comprises Pfizer, Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Roche, Sanofi-Aventis and Wyeth--will pool their data on Stevens-Johnson syndrome, a rare but potentially fatal drug reaction, and liver toxicity [1]. Both side effects occur infrequently, but can be caused by multiple drugs.

Theoretically, it's more evidence of the Brave New World of personalized pharma. But would every patient prescribed a potentially risky drug get the right genetic test? Or would sifting out the vulnerable patients have to wait until we're all carrying ID cards embedded with our personal DNA?

- check out this release [2] for details on the program
- read the New York Times article [3]

Related Articles:
House overhauls, passes PDUFA. Report [3]
Bickering may stall trial database. Report [3]
PDUFA debate highlights drug safety issues. Report [4]
Senate toughens drug safety supervision in PDUFA bill. Report [5]


Source URL:
http://www.fiercepharma.com/story/pharma-fda-study-adverse-events/2007-09-27