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]
Links:
[1] http://www.fda.gov/cder/foi/appletter/2008/021687s022ltr.pdf
[2] http://www.fda.gov/cder/foi/appletter/2008/021445s019ltr.pdf
[3] http://money.cnn.com/news/newsfeeds/articles/djf500/200802141551DOWJONESDJONLINE001013_FORTUNE5.htm
[4] http://www.philly.com/philly/business/20080215_FDA_adds_warning_to_Vytorin.html
[5] http://www.chron.com/disp/story.mpl/ap/fn/5539451.html
[6] http://www.fiercepharma.com/story/fda-to-review-enhance-study/2008-01-28?utm_medium=nl&utm_source=link
[7] http://www.fiercepharma.com/story/merck-schering-defend-embattled-vytorin/2008-01-25?utm_medium=nl&utm_source=link
[8] http://www.fiercepharma.com/story/vytorin-defenders-funded-drugmakers/2008-01-24
[9] http://www.fiercepharma.com/story/vytorin-zetia-scrips-plummet/2008-01-23?utm_medium=nl&utm_source=link