The Food and Drug Administration (FDA) has approved a product label change for the cholesterol-lowering drugs Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin), adding depression as a possible side-effect.
In February 7th and 8th letters to the drugs' co-marketers, Schering-Plough Corp. and Merck & Co., the FDA said depression will be added to the section of the drugs' package insert concerning adverse reactions in post-marketing experience. The new language also will be included in a section of the patient package inserts listing possible side effects of the drugs.
Vytorin is a combination of Zetia and simvastatin. Simvastatin is marketed by Merck under the brand Zocor.
Vytorin and Zetia have been in the news lately because of a recently released study showing that there is no benefit from using either drug. The labeling changes, however, do not appear to be related to this study.
