TUESDAY, Sept. 8, 2009 (HealthDay News) -- Metozolv (metoclopramide) has been approved by the U.S. Food and Drug Administration to treat diabetic gastroparesis and gastroesophageal reflux disease (GERD), drug maker Salix Pharmaceuticals said Tuesday.
Diabetic gastroparesis, caused by nerve damage, occurs when the stomach takes too long to empty. It affects up to 5 million people in the United States, and females are at greater risk than males, Salix said in a news release.
GERD, sometimes referred to as heartburn, affects about 100 million people in the United States. Metozolv was approved to treat GERD when other drugs haven't worked, the company said.
The drug was approved for short-term use of four to 12 weeks. Longer-term use may increase risk of developing a movement disorder called tardive dyskinesia, for which there is no known treatment. In some people, the disorder eases or disappears once Metozolv is stopped, Salix said.
Other adverse effects may include headache, nausea, fatigue, and vomiting.
The FDA has more information about this drug's approval history.