Wyeth (WYE) said Wednesday it revised the label of its blockbuster Effexor drug to include the fact that overdose has been reported, occurring mostly in combination with alcohol and other drugs.
Effexor is indicated for treatment of major depressive disorder. The revision was also made to the extended-release version of Effexor, known as Effexor XR.
In a letter to health-care providers posted on the Food and Drug Administration Web site, the company said death has been reported from overdose of the drug.
The most commonly reported events included tachycardia, changes in levels of consciousness, ranging from somnolence to coma, seizures, and vomiting, it added.
Wyeth also urged health-care professionals to prescribe the smallest quantity of the drug “consistent with good patient management, in order to reduce the risk of overdose.”
A company spokeswoman wasn’t immediately available to comment.