MONDAY, Dec. 1, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a new drug for men with advanced prostate cancer who don't benefit from other treatments.
The Praecis Pharmaceuticals drug Plenaxis (abarelix) will be restricted to only 5 percent to 10 percent of prostate cancer patients -- those who can't tolerate other hormone therapies and who have refused surgical castration, the FDA says.
The restrictions have been imposed because Plenaxis users are at risk of a life-threatening allergic reaction that could cause a dangerous drop in blood pressure. The agency says users should be monitored for at least 30 minutes after being injected with the drug.
Plenaxis is among a group of medicines called gonadotropin-releasing hormone antagonists that are designed to lower levels of the male hormone testosterone -- a key factor in most prostate cancer growth. In 12-week clinical trials involving 81 men, the drug relieved bone pain and helped ease urinary problems. Common side effects included hot flashes, sleep disturbances, pain and constipation.
As a condition of FDA approval, the drug's manufacturer has agreed not to sell it through retail pharmacies, but directly to doctors and hospitals.
For more information, visit the National Cancer Institute.