An unintended consequence of the success of generic drugs is, when it comes to adverse event reporting – who ya gonna call?
Consider, from January 2004 to December 2007 prescriptions of fluoxetine HCl from Eli Lilly and Company made up only 4.5% of prescriptions filled in the US -- yet the good folks at Lilly submitted almost 50% of the fluoxetine HCl ADE reports in the publicly available safety database published by the FDA during that time frame.
We all want a more 21st century and robust AE reporting system. MedWatch? Sure. Janus? Sure. Sentinel? Sure. But surely we can do better yet.
And with FOBs on the horizon, we’d better put the pedal to the metal.
For a very interesting look at AE reporting, check out this article by Mark H. Mayer, et al. from the pages of US Pharmacist.
