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Long-Term Safety of Propecia

Search for ‘hair loss treatments’ on the internet and you’re likely to find lots of rave reviews about Propecia. It’s the first and only pill to treat male pattern baldness and only available via prescription. But despite being clinically proven and medically approved, some doctors are still hesitant to prescribe Propecia as there have been no ten years studies regarding its long-term safety. Yet there is ample evidence that Propecia is a safe and effective hair loss treatment.

Male pattern baldnessPropecia was approved by the U.S. Food and Drug Administration (FDA) in 1997, and it is also approved by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). Its efficacy and safety was originally demonstrated in three one-year, double blind, placebo-controlled, multicentre clinical trials involving 1,879 men aged 18 to 41 with mild to moderate hair loss on the vertex and anterior mid-scalp areas. After more than ten years of being medically approved as a treatment for hair loss, there have been no reports of serious long term side effects as a result of using the 1mg, one-a-day treatment.

Investigational extension studies were also carried out following Propecia’s approval as a treatment for male pattern baldness. Results showed a difference of 277 hairs in a one-inch diameter of the scalp in favour of men treated with Propecia, a stabilisation of hair loss in nine out of 10 of users, and hair re-growth for 48% of users. The five-year study, the longest controlled clinical trial of a hair loss treatment ever reported, provided not only long-term scientific data of Propecia’s effectiveness, but also confirmed the excellent safety profile of Propecia.

Yet in March 2003, the UC Berkeley Wellness Letter suggested cutting the standard 1mg dose into quarters because it was concerned about Propecia’s long-term safety. However a 5mg dose of finasteride (Propecia’s key ingredient), was initially approved by the FDA in 1992 under the branded name Proscar for the treatment of benign prostatic hyperplasia (enlarged prostate). A subsequent long-term, follow-up study of finasteride 5mg per day during a 10-year period found that the drug was well tolerated, with no new adverse experiences occurring with increased duration of exposure.

Propecia FoilExtensive clinical studies proved that Propecia, with just 1mg of finasteride, could safely and effectively treat male pattern baldness. Additionally, the FDA states that studies have confirmed a 1mg dose has greater benefits than a 0.2mg dose, and that doses of 0.01mg per day are ineffective in treating hair loss.

The British National Formulary (BNF), a joint publication of the British Medical Association and the Royal Pharmaceutical Society of Great Britain, aims to provide, pharmacists and other healthcare professionals with sound, up-to-date information about the use of medicines. The BNF recommends Propecia 1mg as an effective dose to treat male pattern baldness and any less is not sufficient to affect the problem.

Some men (and doctors), are concerned about Propecia’s side effects. However, clinical studies showed that they were uncommon and had no long term effects. In the first year of clinical studies, noted side effects included less desire for sex (1.8% vs. 1.3% on placebo), difficulty in achieving an erection (1.3% vs. 0.7%) and a decrease in the amount of semen (0.8% vs. 0.4%). All side effects disappeared in men who stopped the treatment because of them, and by the end of the fifth year, the incidence of those side effects was less than 0.3% in men who continued treatment. The Propecia leaflet states after its list of side effects, ‘the side effects above may disappear after a while if you continue taking Propecia. If these symptoms persist, they usually resolve after stopping Propecia.’

Propecia can also affect PSA (prostate-specific antigen) blood test outcomes so you need to tell your doctor if you’re taking the pill and being screened for prostate cancer. But Propecia has a very short half-life which means once you stop taking it, it should be out of your system in seven days.

Further Reading:
Propecia vs. Procerin vs. Provillus
Best Treatment for a Widow’s Peak
Propecia Found to Reduce Cancer Risk
Propecia Success Stories and How to Get Better Results

Does Generic Propecia Work the Same Way as a Branded one?
My Doctor Told Me Not to Use Propecia
DHT and Propecia in Adult Males

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1 Comment

18th March, 2012 at 8:17 am


I liked the article about the side effects of Propecia. How research proves very little side effects. Great article. thanks!

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