Stay Away from Avodart, Public Citizen Warns

The consumer advocacy group, Public Citizen, has warned men to avoid taking <"">Avodart (dutasteride), a drug used to treat enlarged prostate. According to the group, other treatments, including a class of drug known as alpha blockers, are often safer alternatives for men with this condition.

Avodart is one of a class of drugs known as <"">5-alpha reductase inhibitors, or 5-ARIs. This class also includes Proscar and Propecia (both known generically as finasteride) and Jalyn (dutasteride and tamsulosin). Like Avodart, Proscar and Jalyn are used to treat enlarged prostate (also known as benign prostatic hypertrophy (BPH) or benign prostatic hyperplasia). Propecia is approved to treat baldness in men.

In addition to Avodart, Public Citizen has warned men to avoid finasteride to treat enlarged prostate.

As we’ve reported in the past, 5-ARIs have been associated with a number of serious side effects. This past summer, for example, the U.S. Food & Drug Administration (FDA) warned that 5-ARIs had been linked to a higher risk of high-grade prostate cancer. Such drugs may also increase the risk that users will develop male breast cancer, and studies have linked them to erectile dysfunction and other sexual problems.

According to Public Citizen’s latest issue of “Worst Pills, Best Pills”, a large clinical trial published in 1996 compared the effect of the 5-ARI finasteride with the alpha-blocker terazosin (HYTRIN) in more than 1,000 men with enlarged prostate. The study, which lasted one year, found that terazosin was an effective therapy for enlarged prostate compared to finasteride. The same study also found that a combination of terazosin and finasteride was not more effective in enlarged prostate patients than terazosin alone. While finasteride did work well a group of men with very large glands, terazosin was effective in men with both very large or small prostate glands.

A 2003 study that involved more than 3,000 men and lasted four and a half years, known as the Medical Therapy of Prostatic Symptoms (MTOPS), did conclude that that the combination of finasteride and terazosin was superior to either of the drugs used alone, Public Citizen said. However, the MTOPS trial also pointed to a possible association between finasteride use and male breast cancer. In the trial, the rate of male breast cancer was nearly 200 times greater than what is seen in men in the general population.

Public Citizen also cited two large, recent studies which found that while 5-ARIs reduced the overall risk of prostate cancer, they increased the risk that a user would develop a more serious type of tumor known as high-grade prostate cancer. This type of tumor grows and spreads faster compared to low-grade prostate cancer. Over the summer, findings of those studies prompted the FDA to add warnings about high-grade prostate cancer to the “Warnings and Precautions” sections of the labels for all 5-ARIs.

In the “Worst Pills, Best Pills” article, Public Citizen urges men with enlarged prostate to consider alternatives to treat enlarged prostate. The article points out that in men with minimal symptoms, no treatment is necessary. Alpha blockers like terazosin, as well as alfuzosin (UROXATRAL), prazosin (MINIPRESS), tamsulosin (FLOMAX), or doxazosin (CARDURA) should be considered by men experiencing symptoms. Surgical procedures are also an option for men with severe symptomatic enlarged prostate, Public Citizen said.

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