Avodart/Propecia/Proscar and Impotence/Prostate and Male Breast Cancer

In an article published in the March 2011 issue of The Journal of Sexual Medicine, researchers from the Boston University School of Medicine confirmed what recent lawsuits have already alleged, namely that there is a link between the use of dutasteride (Avodart) and finasteride (Proscar and Propecia) and temporary and sometimes permanent sexual dysfunction including erectile dysfunction and loss of labido.

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Notably, more than double the percentage of men reported erectile dysfunction while on one of the drugs compared to placebo. Further, a loss of sex drive was reported more than twice as frequently among those taking one of the drugs compared to placebo. Other reported side effects of Avodart, Proscar and Propecia included depression, reduced semen production and growth of male breast tissue.

The most devastating information presented, however, relates to symptoms of the side-effects persisting even after the medication was discontinued. In fact, in a second study reported within the same volume of The Journal of Sexual Medicine, Dr. Michael S. Irwig interviewed 71 otherwise healthy men who reported sexual side effects after taking finasteride and determined the mean duration of the negative sexual impact to be 40 months after stopping the drug. Despite the absence of any such information on the drugs’ labeling in the United States, these prolonged side-effects do appear on the updated labeling for these drugs in European nations such as Great Britain, Sweden and Italy.

Merck’s Proscar (finasteride) was originally approved by the FDA in 1992 for the treatment of urinary problems because of the drug’s ability to decrease the size of an enlarged prostate by reducing the enzymes that turn testosterone into DHT, which represents the primary cause of prostate growth. However, enlarged prostate patients noticed that the drug also fostered hair growth in areas of the scalp where their hair had been thinning. Thus, Proscar, after being rebranded as Propecia, received approval from the FDA in 1997 for the treatment of male pattern baldness. Avodart, which was approved in 2002 for treatment of an enlarged prostate, is reportedly even more effective at supporting hair growth but has surprisingly not been submitted by GlaxoSmithKline to the FDA for approval of that additional indication. Perhaps knowledge of the potential long-term or permanent sexual side-effects, combined with the doubled risk of heart failure in men taking Avodart, as reported in The New England Journal of Medicine last March, is enough for GlaxoSmithKline to try to avoid increased exposure.

In June 2011, the FDA mandated the labels for 5-alpha reductase inhibitors warn about the risk of prostate cancer. FDA Alert.  The prostate cancer risk is apparently the kind which is “high grade,” meaning it grows and spreads faster than the more common form of prostate cancer. Further, there are safer alternatives for the treatment of enlarged prostate, which include drugs knownas alpha blockers.

FDA warnings were based on two studies showing that males who took these drugs were more likely to develop aggressive prostate tumors compared to males on placebo. One of those studies followed 8,000 males aged 50-79 for four years. It found that, while there was a 23% overall lower risk of being diagnosed with biopsy detectable prostate cancer, there was an increased incidence of high-grade prostate cancers.

Most prostate cancers are found before they cause any symptoms. A PSA blood test is typically done to screen for prostate cancer. Some of the early symptoms may include delayed or slow urinary stream or leakage, straining when urinating, and/or blood in the urine.

In addition to the risk of permanent impotence and high grade prostate cancer, in August 2011, officials in Canada mandated that these drugs’ labels include information regarding a risk of male breast cancer. According to Health Canada, most of the male breast cancers reported are associated with the 5mg dose of these drugs. It is advised that any patients taking Avodart, Proscar or Propecia should see their doctor if they experience any signs of breast enlargement, breast lumps, pain or tenderness, nipple discharge or any other changes while taking the drug.

If you are taking one of these drugs, speak to your doctor about whether the risk of permanent impotence, high grade prostate cancer and male breast cancer outweigh the benefits that you’re receiving from the use of these drugs. If you or a loved one have taken then drugs and have suffered from long-term or permanent sexual side-effects, prostate or breast cancer, it is important to find legal representation with a history of standing up to pharmaceutical companies. Contact the attorneys at Pogust Braslow & Millrood.