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

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