WASHINGTON -- The FDA has issued a warning of an increased risk of high-grade prostate cancer with the 5-alpha reductase inhibitors finasteride (Proscar) and dutasteride (Avodart), currently approved to treat benign prostatic hypertrophy. The agency announced Thursday that it has updated the Warnings and Precautions section of labels for the class of drugs -- which includes branded products Propecia and Jalyn under which finasteride and dutasteride are marketed for other indications -- to reflect the increased risk. "This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," the agency wrote in its safety announcement. Avodart, Jalyn, and Proscar are approved to treat symptoms of an enlarged prostate. Propecia, at a 1-mg dose, is approved to treat hair loss in men. The announcement follows the FDA's Oncologic Drugs Advisory Committee's vote of 17-0 in December that Glaxo Smith Kline's dutasteride and Merck's finasteride should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors. Glaxo Smith Kline was seeking to expand dutasteride's indication to include reducing the risk of prostate cancer in men who have had a prior negative biopsy and who have an elevated PSA. Propecia Side Effect 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. Food & Drug Administration (FDA) has mandated that the labels for Propecia 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. If you used Propecia (finasteride 1 mg) and were diagnosed with an aggressive form of prostate cancer or male breast cancer, this drug could be to blame. 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 Propecia or Pro Scar and the development of Male Breast Cancer. We are currently offering free lawsuit evaluations to anyone who was diagnosed with any of these serious side effects while using Propecia.
Androgenetic alopecia, breast cancer, cancer, Finasteride, hair loss, hair transplant surgeons, Journal of Urology, male hair loss, male pattern baldness, non-surgical hair restoration, prescription medications, Propecia, surgical hair restoration Finasteride (brand name Propecia®) is known among male hair loss sufferers as a powerful prescription medication capable of ceasing hair loss. Like all prescription medicines, Propecia is not without side effects. Most know that the medication may cause sexual side effects for the men who take it regularly. But are men also at risk of developing breast cancer? Physicians have long prescribed Finasteride, and in some cases Dutasteride, to treat symptoms of enlarged prostate in men, or benign prostatic hypertrophy (BPH). As a 5-alpha reductase inhibitor, the medicine also helped to cease hair loss in subjects by warding off the chemical reaction that researchers believe causes hair follicles to stop producing hair. However, post-marketing data demonstrated some risk. Specifically, rare reports indicated that male breast cancer were a side effect of Finasteride treatment. A Fred Hutch study has found that the steroid finasteride, long used to treat prostate enlargement and hair loss, can protect men from developing prostate cancer for up to 16 years. Stock photo by Feature Pics A drug used to treat enlarged prostate or hair loss in men has been shown to have a long-term protective effect against prostate cancer. The study, led by Fred Hutchinson Cancer Research Center biostatistician Dr. Joe Unger and recently published in Journal of the National Cancer Institute, linked data from a large prostate cancer clinical trial conducted by the clinical trial network SWOG with Medicare claims data to determine that the steroid tablet finasteride could protect men from developing the cancer for up to 16 years. The original NCI-funded study, known as the Prostate Cancer Prevention Trial, set out to determine if finasteride (also known as Proscar or Propecia) could prevent prostate cancer in men ages 55 and older. That study, which came to an end in 2003, found finasteride use for seven years reduced a man’s risk of developing prostate cancer by 25 percent and that the protective benefit lasted through that seven-year period, which is how long the study followed participants. Dawn Hershman of Columbia University Medical Center, and Drs. Unger and his colleagues went back to the PCPT cohort of nearly 19,000 healthy men (half of whom were given finasteride and half whom received a placebo) to see if finasteride offered a longer-term benefit. Scott Ramsey and Catherine Tangen of Fred Hutch, then created an algorithm to flag PCPT participants on Medicare who’d been diagnosed with and/or treated for prostate cancer.
Propecia should never be taken by a woman or a child. Finasteride can be absorbed through the skin, and women or children should not be permitted to handle Propecia tablets. Although Propecia is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Feb 27, 2017. Propecia, the brand name for drug giant Merck's finasteride, has. About 50 lawsuits allege that Propecia caused or can cause prostate cancer.