Another week, another drug-safety alert from FDA. This time, it's hormone treatments for prostate cancer. The agency says drugs such as Abbott Laboratories' Lupron and AstraZeneca's Zoladex need new warnings about a small increased risk of diabetes and heart trouble, including sudden death.
The FDA announced back in May that a preliminary analysis of six studies had found increased risk of diabetes, heart attack, stroke and sudden death in patients using gonadotropin-releasing hormone agonists. The drugs suppress testosterone production to prevent growth of prostate cancer. The agency's analysis came after a February article in Circulation suggesting that this type of prostate-cancer treatment--known as androgen deprivation treatment--likely would raise the risk of heart attack.
Now, the agency's analysis of those six studies is complete, and it says these potential risks are are backed by enough data to warrant adding warnings to the entire drug class. Besides Lupron and Zoladex, this drug class also includes Sanofi-Aventis' Eligard, Watson Pharmaceuticals' Trelstar, Endo Pharmaceutical's Vantas, and Pfizer's Synarel, among others.
- see the statement from the FDA
- read the Reuters news