Men, are you taking this dangerous drug unnecessarily?

Sounding a LATE alarm

The tortoise-and-hare split personality of the FDA never fails to drive me mad!

When it’s time to review a drug for approval, the agency takes on the personality of a speedy hare. Drugs get fast-track approvals while safety concerns are literally put off until tomorrow.

But when mounting evidence of risk makes it obvious that something has to be done to protect patients, the agency becomes a tortoise, taking its slow sweet time to drag itself into action.

What an insane system! Sometimes I think FDA officials forget they’re dealing with real humans instead of columns of numbers.

What has me so angry today? A class of prostate cancer drugs that–despite grave cardiovascular risks–are often given to men who have no cancer at all.

Come ON FDA! These are dangerous drugs! Get moving, you laggards!

Playing catch up

Three and a half years ago I first told you about the serious dangers linked with a class of prostate cancer drugs known as GnRH agonists. Brand names include Lupron, Zoladex, and Trelstar.

Since then, these drugs have been prescribed to thousands of men who didn’t have cancer, so never actually needed them! In these cases, the drugs are given as a precaution when PSA levels are elevated.

So last spring, the FDA signaled that there might be something important going on here. The agency announced a “preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists.”

As warnings go, that’s not exactly a clear alarm bell–especially considering this information was available YEARS ago! Way to catch up, FDA!

Then this past autumn, the agency finally got around to asking GnRH agonist makers to revise their drug information sheets with a new warning label.

So maybe–MAYBE–doctors will wake up and stop giving these drugs to men who don’t need them!

Last May, urologist Dr. Mark Soloway, told HealthDay News that there are “hundreds of thousands” who are taking a GnRH agonist simply because their PSA level had a slight rise.

Dr. Soloway: “I think hormone therapy can be delayed for months to years in some of these men.”

Keep in mind, Dr. Soloway is not what you’d call an alternative medicine kind of guy (he’s the chair of urology at the University of Miami Miller School of Medicine). He absolutely believes in using this drug to treat prostate cancer. But he absolutely believes it’s being misused in many cases.

More recently, Nicholas Vogelzang, M.D., explained to Medpage Today that some men with prostate cancer live with “extreme, excruciating pain.” But when they begin using a GnRH agonist, “they get not just extension of life but dramatic resolution of symptoms from the cancer. They become virtually asymptomatic.”

In cases like that, the added dangers of heart disease and diabetes may be worth the risk. But we can only hope that doctors are getting the message loud and clear: Use only when really, genuinely, absolutely MEDICALLY necessary!

Sources:
“FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and Possible Increased Risk of Diabetes and Certain Cardiovascular Diseases” FDA Safety Announcement, 5/3/10, fda.gov
“As FDA Eyes Prostate Cancer Drugs, Experts Urge Caution” Steven Reinberg, HealthDay News, 5/4/10, healthday.com
“GnRH Agonist Warning Restates the Facts” Charles Bankhead, MedPage Today, 10/28/10, medpagetoday.com