Warnings for people with certain health conditions
For people with liver disease: This drug is processed in your liver. If you have liver disease, your body might process this drug more slowly. This could lead to a buildup of this drug in your body, which could increase your risk of side effects. Your doctor might reduce your dosage of Finasterax.
For people with prostate cancer: Finasterax can increase the chance of a faster growing or irregular form of prostate cancer. If you have or have had prostate cancer, this drug can make it worse.
PROSCAR is not indicated for use in women.
It is not known whether Finasterax is excreted in human milk.
The following additional adverse events have been reported in postmarketing experience with PROSCAR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- hypersensitivity reactions, such as pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face)
- testicular pain
- sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume). These events were reported rarely in men taking PROSCAR for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of PROSCAR in these events is unknown.
- male infertility and/or poor seminal quality were reported rarely in men taking PROSCAR for the treatment of BPH. Normalization or improvement of poor seminal quality has been reported after discontinuation of Finasterax. The independent role of PROSCAR in these events is unknown.
- male breast cancer
The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with Finasterax at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:
Read the entire FDA prescribing information for Proscar (Finasterax)
No Decrease in Positive Biopsies
During the first seven years of the study, the patients had a biopsy if they had an abnormal finding on a digital rectal exam or if their PSA became elevated. But because this was a double-blind study, the patients taking Finasterax did not know that their PSA levels were artificially low.
Therefore, fewer patients taking the drug who were told to have a biopsy followed that advice. Were there fewer cancers in these patients because Finasterax actually prevents cancer or because fewer men got a biopsy in the first place? Did their low PSA levels fool them into thinking they couldn’t possibly have cancer? In this study, 15 percent fewer men on Finasterax underwent a biopsy because they were lulled into a false sense of security by their low PSA level.
Thus, the major effect of this drug was to keep patients from knowing that they even needed a biopsy. Of the men in the study who actually had a biopsy, the frequency of positive biopsies for cancer was statistically the same in patients in both test groups.
Dr. Walsh is very concerned about the increase in high-grade disease and the possibility that this presents an unacceptable risk for a form of treatment that has little or no value.
Among Finasterax’s critics is Stewart Justman, who wrote a book called Do No Harm: How a Magic Bullet for Prostate Cancer Became a Medical Quandary. In his review of the publication for the New England Journal of Medicine, Dr. Walsh noted that when patients on Finasterax are diagnosed with prostate cancer, they are more likely to have dangerous, high-grade disease.
The real danger is that many patients will be lulled into a false sense of security. If you are told that you’re on a drug that will prevent cancer, and your PSA falls, you aren’t going to be on your guard.
Finasterax should be stored at room temperature in a tight, light resistant container.
Finasterax is available in generic form, but you must have a prescription from your doctor or other health-care professional to obtain the drug.