Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall

Justinian Lane's Blog

Justinian's Blog

Europe refuses to approve diet pill already approved here

Remember fen-phen?  If you don’t, it was a diet pill that basically did the equivalent of dropping your heart valves into a Vitamix and hitting pulse.  For whatever reason, it seems like most diet drugs seem to come with serious heart risks.  European regulators are more risk averse than their American counterparts, and they have rejected the diet drug sold here as Qsymia.  Not sure which marketing geniuses came up with THAT name, but regardless, it won’t be available in Europe until they do a long-term study of heart safety.

My bet? Vivus decides that the risks of doing such a study outweigh the benefits of selling in Europe.  After all, if the study turns out to produce bad safety data, Vivus has to tell the FDA.  And if the FDA doesn’t like the study, the drug gets yanked.  And if the drug gets yanked, lawsuits follow.

European health regulators for a second time rejected a diet pill developed by Vivus Inc and said the obesity treatment would not be approved there unless the company conducts a large lengthy trial to prove its heart safety, Vivus said on Thursday.

Source: European regulators reject Vivus diet pill again - Yahoo! News