Depression added to Vytorin, Zetia labels

Apparently, it's not only investors and company execs that are depressed by the cholesterol meds Vytorin and Zetia. The FDA has approved a label change adding depression as a possible side effect of the drugs. The agency said the new language will be added to post-marketing adverse reactions, and it will be listed as a potential side effect in another section of the package insert.

Of course, Vytorin and Zetia have been under pressure since last month's release of a trial showing that Vytorin--a combo of simvastatin and Zetia--didn't slow artery clogging any better than simvastatin alone, despite cutting "bad" cholesterol more effectively. Made by Merck and Schering-Plough, Vytorin has lost market share since the study was released, and both companies' have seen their stock suffer--though their shares have since rebounded somewhat. One analyst has even elevated Schering to a "buy" rating.

- check out the FDA's letter [1] to Merck about the label change
- get the agency's letter [2] to Schering-Plough
- read the Dow Jones story [3]
- see more [4] in the Philadelphia Inquirer
- check out the Schering stock news [5] in the Houston Chronicle

Related Articles:
FDA to review Enhance study. Report [6]
Merck, Schering defend embattled Vytorin. Report [7]
Vytorin defenders funded by drugmakers. Report [8]
Vytorin, Zetia scrips plummet. Report [9]