Bernstein Medical - Center for Hair Restoration - Propecia Label Information
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Q: I read your 20 pages of FAQs but could not find this question addressed. I’m currently taking Finasteride 5 mg (one-fourth tablet per day), but since some drug companies make an oblong tablet that is hard to cut into four pieces, I found a plastic bottle with four equal measurements and I dissolve the tablet in water, shake it up and drink one-fourth of the liquid each day. I read somewhere that you’re not really supposed to dissolve the pill in water. Is that correct or is it OK to keep doing it the way I’m doing? — W.I., Winnetka, Illinois

A: I would cut up the pills with a pill-cutter – they do not need to be in equal parts. Just finish a whole pill every four days. You can also take ½ pill every other day and achieve the same effect. I am not sure of the stability of the medication in water over several days. It is probably OK, but why take the chance?

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The central finding of a 2004 study led by Italian researcher Dr. Antonella Tosti, in which he and his team investigated sexual dysfunction in hair loss patients being treated for androgenetic alopecia, was that there was no statistically significant change in sexual function after four to six months of treatment with finasteride 1mg (Propecia).

The researchers used a questionnaire, called the abridged 5-item version of the International Index of Erectile Function (IIEF-5), to measure sexual function in the men in the study. The questionnaire, which is considered an internationally valid diagnostic tool for distinguishing between men with and without erectile dysfunction, asks the patients 15 questions on the topics of: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. By administering the questionnaire both before and after treatment with finasteride, the researchers were able to determine if sexual function was impaired by the treatment.

The result of this investigation in the sexual function of 186 patients was that, “the erectile function of all patients remained stable after 4 to 6 months of treatment with finasteride 1 mg.”

Interestingly, the research team found that sexual side effects were actually less common than reported in the clinical trials of the drug. They suggest that this difference was potentially due to the fact that subjects in the clinical trials were made aware of the potential for sexual side effects, and were asked about these side effects upon each visit, which led to higher reporting of side effects than what would otherwise be the case.

Reference:

Tosti A, Pazzaglia M, Soli M, Rossi A, Rebora A, Atzori L, Barbareschi M, Benci M, Voudouris S, Vena GA. Evaluation of Sexual Function With an International Index of Erectile Function in Subjects Taking Finasteride for Androgenetic Alopecia. Arch Dermatol. 2004;140:857-858.

Download the Tosti study of erectile function and finasteride

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The 2011 study published by a research team led by Dr. Alfredo Rossi, is the first comprehensive investigation on long-term safety and efficacy of finasteride 1mg (Propecia).

In “Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up,” the Italian research team sought to fill a gap in our understanding of the long-term effects of treating hair loss with Propecia. The study tracked hair growth in 118 men between the ages of 20 and 61, with mild to moderate hair loss, who were treated with 1mg finasteride. These patients were evaluated before treatment and then again at 1, 2, 5, and 10 years on treatment.

The result of testing found not only that Propecia works and is safe for use, but there were some other interesting findings as well. Only 14% patients experienced a worsening of hair loss, while 86% benefited from the treatment over this extended time period and efficacy of the drug was found not to reduce over time for the majority of patients.

One of the most interesting findings is that patients who had hair growth in their first year of treatment are more likely than others to have better hair growth after 5 years. About half of patients experienced good hair growth in their first year, and about 53% of those patients went on to see improved growth over time. However, of the group with unchanged or worse results in their first year, only 25% saw improved hair growth after 5 years. After 10 years, almost 69% of patients who experienced growth in their first year experienced continued growth. Only 32% of those who saw unchanged or worse results after their first year had growth at 10 years.

The authors concluded that a patient’s response to finasteride in the first year is a pretty good indicator of how effective long-term treatment will be for the patient. The better growth he experiences in his first year, the more likely he will have continued growth beyond 5 years of treatment.

Among other findings, the age of a patient did have a statistically significant effect on the outcome, as patients older than 30 years had better hair growth in the long term. On the topic of side effects, 7 subjects (5.9%) experienced them, and some of those patients remained in the study because of what they perceived as the benefits of the treatment.

In conclusion, the authors found that Propecia is a safe and effective hair loss medication, even when used long-term. It is effective in patients older than 40 years and it is particularly beneficial for patients over 30 and who are in early stages of hair loss. Perhaps the most important finding is that a patient’s response to finasteride after the first year of treatment can be an indicator of the patient’s success with the drug in the long-term.

Reference:

Rossi A, Cantisani C, Scarnò M, Trucchia A, Fortuna MC, Calvieri S. Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up. Dermatol Ther 2011; Jul-Aug;24(4):455-61.

Download the Rossi study of finasteride long-term effects

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On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual adverse events reported to FDA as some of these events have been reported to continue after the drug is no longer being used (note that erectile dysfunction after stopping use of these drugs was added as a known event in 2011). The new label changes include:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.

Propecia

Only a small percentage of men using these drugs have experienced a sexual adverse event. During treatment with Propecia, 3.8% of men had reported one or more adverse sexual experiences as compared to 2.1% men who did not receive Propecia (received placebo). This represents a 1.7% difference.

For Propecia, the FDA’s Agency’s Adverse Events Reporting System (AERS) database between 1998 and 2011 found 59 cases of reported sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders.

The FDA has not established a cause and effect relationship between finasteride and the sexual adverse events that continued after stopping drug use. The FDA believes that finasteride remains a safe and effective drug for its approved indications. Healthcare professionals and patients should consider this new label information when deciding the best treatment option.

For more information, read this PDF document: Questions and Answers: Finasteride Label Changes.

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