The FDA has approved a change in the product labels for cholesterol drugs Vytorin and Zetia, adding depression as a possible side effect of the drug.
In letters to the drugs' co-marketers, Schering-Plough Corp. (SGP) and Merck & Co. (MRK), the FDA said depression would 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.
The section of the product label being changed is for adverse reactions reported in post-marketing experience, "regardless of causality assessment." The FDA approved the label changes Feb. 7 and Feb. 8, its Web site indicates.
Vytorin is a combination of Zetia and simvastatin. Simvastatin is available generically and is marketed by Merck under the brand Zocor.