Market Name: Arthrotec

Generic Name: Diclofenac sodium/misoprostol

Arthrotec 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 Arthrotec including peptic ulcers, bleeding and perforation of the stomach/intestines. In addition, serious cardiovascular events including stroke and heart attack were observed. Arthrotec also increases the risk of kidney problems, bleeding, and fetal problems during pregnancy and delivery.

A black box warning was added to Arthrotec’s prescribing information by the FDA in July of 2005.

Black Box Warning Date: July 2005

FDA Link: Arthrotec