FDA Warning on Prostate Cancer Drugs

This week, the FDA announced that a certain class of drugs used to treat prostate cancer are linked to higher rates of heart disease and diabetes. The drugs, known as GnRH agonists or androgen deprivation therapy, work by suppressing the production of the male sex hormone, testosterone. Because testosterone fuels the growth of prostate cancer, stopping its production helps fight prostate cancer.

fda warning on GnRH agonists or androgen deprivation therapy

However, reducing testosterone also creates "male menopause". It is well known that male menopause has side effects seen in women's menopause, such as hot flashes and bone loss. But new evidence shows that it can also cause more serious heart problems and diabetes, and it may be related to the "metabolic syndrome." This has important implications for prostate cancer choices, and I'll go over some questions you might have.

What are the names of the drugs involved in the warning?Although there are many of these drugs, the most commonly used are Lupron and Zoladex, also known as leuprolide and goserelin.

Who are these drugs prescribed for? Is it important that they receive them?

There are three groups of patients who are prescribed androgen deprivation: 1)Patients with advanced or metastatic prostate cancer. These patients are at substantial risk for dying from prostate cancer, so the increased risk of heart disease and diabetes is worth this risk.

2)Patients newly diagnosed with prostate cancer who do not wish to undergo surgery or radiation. Such "primary" use of androgen deprivation has been discouraged, and this new evidence will hopefully further reduce the number of patients who receive it for this purpose

3)Patients undergoing radiation for high risk disease or seeds with large prostates. In order for radiation to be effective in high risk patients (those with high PSA or Gleason scores), it needs to be combined with androgen deprivation for 2 or 3 years. It is also used to shrink large prostates before placing radioactive seeds.

How should this risk of androgen deprivation affect my prostate cancer decision?When discussing your options for prostate cancer with your doctor, you should specifically ask if you will need androgen deprivation. If they recommend including it as part of your treatment, I would ask them about other treatment alternatives. For example, surgery does not require androgen deprivation to be effective, so it avoids the risks of heart disease and diabetes associated with it. But, in certain patients, radiation does need androgen deprivation to be effective. If you are one of those patients, you may want to consider surgery instead.

Considering that all forms of treatment for localized prostate cancer have excellent cure rates at 15 years, these additional risks of heart disease and diabetes may outweigh the potential benefits of radiation.