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PROPECIA (FINASTERIDE): ADVERSE REACTIONS, SIDE EFFECTS

Clinical Studies for Propecia (Finasteride) in the Treatment of Male Pattern Hair Loss

In three controlled clinical trials for Finasteride (Propecia) tablets of 12-month duration, 1.4% of patients taking this drug (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).

Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in >= 1% of patients treated with Finasteride (Propecia) or placebo: decreased libido, ejaculation disorder (decreased volume of ejaculate), erectile dysfunction, discontinuation due to drug-related sexual adverse experiences.

Integrated analysis of clinical adverse experiences showed that during treatment with Propecia, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with Propecia (Finasteride) 1 mg tablets due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to <= 0.3% by the fifth year of treatment with Propecia (Finasteride).

In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of Propecia (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.

In the clinical studies with Propecia (Finasteride) tablets, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

Postmarketing Experience for Propecia (Finasteride 1 mg)

Breast tenderness and enlargement; depression; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; testicular pain; and male breast cancer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Controlled Clinical Trials and Long-Term Open Extension Studies for Proscar (Finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia

In the Proscar Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on Proscar 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with Proscar 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Here are the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on Proscar was >= 1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder: decreased libido, impotence, decreased volume of ejaculate, breast enlargeme, ejaculation disorder, breast tendernes, rash.

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5year open extensions with Proscar 5 mg and PLESS were similar.

There is no evidence of increased adverse experiences with increased duration of treatment with Proscar (Finasteride) 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Proscar but no cases in men not treated with Finasteride (Proscar). During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Proscar. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Proscar (Finasteride), and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men >= 55 years of age with a normal digital rectal examination and a PSA <= 3.0 ng/mL. Men received either Proscar (Finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5-alpha-reductase inhibitor (Dutasteride, Avodart), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of Propecia by men is unknown.

No clinical benefit has been demonstrated in patients with prostate cancer treated with Proscar. Finasteride (Proscar) tablets is not approved to reduce the risk of developing prostate cancer.

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