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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 to Merck about the label change
- get the agency's letter to Schering-Plough
- read the Dow Jones story
- see more in the Philadelphia Inquirer
- check out the Schering stock news in the Houston Chronicle
Related Articles:
FDA to review Enhance study. Report
Merck, Schering defend embattled Vytorin. Report
Vytorin defenders funded by drugmakers. Report
Vytorin, Zetia scrips plummet. Report
Comments
I had high level of side physical effect when using Vytorin for about 8-10 months to reduce my cholesterol that was about 240. Among the most severe were loss of muscles mass in the legs, a general feeling of weakness and other many strange side effects (never experienced before)too numerous to list. The cholesterol went down to about 170. I stopped the Vytorin for a few months the cholesterol started to increase above 200. Started again with 1/2 the lowest dose available 10/10 mg or 5/5 mg. the side effect have subsided and the general sense of tiredness is basically gone. The description of this drog, does not adequately list all the possible side effect that can impact considerably the quality of life. Still now I am worrying about other consequences that may show up in the future even with a reduce mg dose. I guess I still have the option to stop taking it.
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