drugs information
Tolectin Black Box Warning
Market Name: Tolectin
Generic Name: Tolmetin sodium
Tolectin is a non-steroidal anti-inflammatory drug indicated for the short-term relief of moderate to severe pain. Serious gastrointestinal side effects have occurred with Tolectin, including peptic ulcers, bleeding and perforation of the stomach/intestines. In addition, serious cardiovascular events including stroke and heart attack were observed. Tolectin also increases the risk of kidney problems, bleeding, and fetal problems during pregnancy and delivery.
A black box warning was added to Tolectin’s prescribing information by the FDA in February of 2006.
Black Box Warning Date: February 2006
FDA Link: Tolectin