Propecia (Finasteride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss

In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (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 PROPECIA or placebo are presented in Table 1.

TABLE 1. Drug-Related Adverse Experiences for PROPECIA (finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS

	PROPECIA N=945	Placebo N=934
Decreased Libido	1.8	1.3
Erectile Dysfunction	1.3	0.7
Ejaculation Disorder   (Decreased Volume of Ejaculate)	1.2 (0.8)	0.7 (0.4)
Discontinuation due to drug-related sexual adverse experiences	1.2	0.9

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 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.

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, 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; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; and testicular pain. See Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia.

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.

Table 2 presents 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.

TABLE 2. Drug-Related Adverse Experiences for PROSCAR (finasteride 5 mg) BENIGN PROSTATIC HYPERPLASIA

N = 1524 and 1516, finasteride vs placebo, respectively
	Year 1 (%)		Years 2, 3 and 4 1 (%)
	Finasteride, 5 mg	Placebo	Finasteride, 5 mg	Placebo
Impotence	8.1	3.7	5.1	5.1
Decreased Libido	6.4	3.4	2.6	2.6
Decreased Volume of Ejaculate	3.7	0.8	1.5	0.5
Ejaculation Disorder	0.8	0.1	0.2	0.1
Breast Enlargement	0.5	0.1	1.8	1.1
Breast Tenderness	0.4	0.1	0.7	0.3
Rash	0.5	0.2	0.5	0.1

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5- year 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 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

The relationship between long-term use of finasteride and male breast neoplasia is currently unknown. During a 4- to 6-year placebo- and comparator-controlled 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 PROSCAR. In another 4-year, placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with PROSCAR.

In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the PROSCAR group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when PROSCAR is used as indicated. PROSCAR is not approved to reduce the risk of developing prostate cancer.

REPORTS OF SUSPECTED PROPECIA SIDE EFFECTS / ADVERSE REACTIONS

Possible Propecia side effects / adverse reactions in 40 year old male

Reported by a physician from Germany on 2011-10-03

Patient: 40 year old male weighing 86.0 kg (189.2 pounds)

Reactions: Antiphospholipid Syndrome, Pulmonary Embolism

Adverse event resulted in: hospitalization

Suspect drug(s):
Propecia

Possible Propecia side effects / adverse reactions in 23 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-10

Patient: 23 year old male weighing 73.0 kg (160.6 pounds)

Reactions: Breast Pain, Breast Mass

Suspect drug(s):
Propecia

Possible Propecia side effects / adverse reactions in 36 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-13

Patient: 36 year old male

Reactions: Testis Cancer, Gynaecomastia

Adverse event resulted in: hospitalization

Suspect drug(s):
Propecia