Finasteride use (Propecia, Proscar) may increase Male Breast Cancer Risk – Health Canada. FDA Says Prostate Drugs Can Cause High-Grade Prostate Cancer. In August 2011, regulators in Canada announced that the labels of Finasteride (Propecia & Proscar) products sold in Canada would be updated to include information regarding their possible association with male breast cancer. According to Health Canada, male breast cancer has been reported in a small number of patients worldwide with both the 1 mg and 5 mg formulations of finasteride, though most have been associated with the 5mg formulation. Health Canada has advised that men taking finasteride contact their doctors should they experience breast enlargement, breast lumps, pain or tenderness, nipple discharge, or any other changes while taking the drug.
Proscar and Aggressive Prostate Cancer
If you used Proscar (finasteride 5mg) and were diagnosed with an aggressive form of prostate cancer or male breast cancer, this drug could be to blame. The U.S. Food & Drug Administration (FDA) has mandated that the labels for Proscar and other drugs in a class known as 5-alpha reductase inhibitors, or 5-ARIs, include warnings about an increased risk of high-grade prostate cancer, a more serious and aggressive form of the disease.
High-grade prostate cancer grows and spreads faster compared to low-grade prostate cancer. Additionally, the FDA is investigating a possible link between the use of Proscar or ProScar and the development of Male Breast Cancer.
Another study has found a link between Erectile Dysfuntion and Propecia or ProScar(finasteride). Men who developed high-grade prostate cancer, erectile dysfunction or male breast cancer while taking this Proscar may be eligible for compensation, and should contact the Proscar lawyers at Parker Waichman LLP. We are currently offering free lawsuit evaluations to anyone who was diagnosed with any of these serious side effects while using Proscar.
Proscar (finasteride 5mg) is used to treat enlarged prostate. The FDA ‘Proscar’ prostate cancer warning was based on two studies that indicated men who took 5-ARIs were more likely to develop aggressive prostate tumors compared to men on a placebo. One of the trials reviewed by the FDA, the Prostate Cancer Prevention Trial (PCPT), followed more than 18,000 men aged 55 or over for up to seven years who were treated with either finasteride 5 mg or a placebo. While the men in the finasteride group had a lower overall risk of developing prostate cancer, that was due mainly to a reduction in the occurrence of low-grade tumors. There was, however, an increase with high-grade prostate cancers with finasteride (1.8%) versus placebo (1.1%), the FDA said.
Proscar and Male Breast Cancer
Recent evidence suggests that men who take drugs that contain finasteride, including Proscar or
Propecia, may be at higher risk for this extremely rare disease. Male breast cancer strikes only one out of every 100,000 men in the general population. However, according to information printed on the drug’s label, four cases of breast cancer were reported among those treated with Proscar during a clinical trial that involved 3,047 men taking either ‘Proscar’ or a placebo. No cases of the disease were reported among the men taking a placebo. In 2009, an analysis by the U.K. Medicines and Healthcare products Regulatory Agency found a total of 53 men worldwide on finasteride had developed breast cancer. In 2010, the U.S. Food & Drug Administration (FDA) mandated that information regarding a possible association with male breast cancer be included on the labeling of Proscar and other drugs that contain finasteride.
There is growing evidence that use of Proscar may be associated with male breast cancer. A 2004 study published in The Journal of the National Cancer Institute reported that breast cancer had been observed in some men using finasteride. In 2009, an analysis by the U.K. Medicines and Healthcare products Regulatory Agency found a total of 53 men worldwide on finasteride had developed breast cancer. In May 2010, the U.S. Food & Drug Administration (FDA) announced it was investigating a possible link between finasteride and male breast cancer. New information regarding a possible risk of male breast cancer was added to the U.S. labels of drugs containing finasteride, including ‘Proscar’, in October of that year. Men taking Proscar are advised to call their doctor if they experience breast lumps, pain, nipple discharge, or other breast changes, as these may be signs of male breast cancer.
Proscar and Erectile Dysfunction
Men taking Proscar have also been known to suffer from erectile dysfunction. ‘Proscar’ and similar drugs work by blocking androgen, which plays a key role in erectile function, libido and ejaculation. The makers of Proscar and other drugs containing finasteride have reported that up to 8 percent of users experienced sexual problems, while a 2008 paper published in the Journal of Sexual Medicine said the true number could be as high as 38 percent, depending on dose and duration.
Another study published in the same journal in March 2011 found that erectile dysfunction caused by drugs like Propecia or ‘Proscar’, which contain finasteride may sometimes be irreversible. That study looked at 71 men who reported erectile dysfunction and other sexual problems while taking finasteride. The average duration of persistent sexual side effects was 40 months after they stopped taking the medication. About 20 percent of the men still had side effects more than six years after stopping finasteride.