|
Integrated
analysis of
clinical adverse
experiences showed that during
treatment with
Propecia (finasteride), 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) 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
Propecia (finasteride), 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 (finasteride) (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), 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 ³1% 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 |
|
Year 1 (%) |
Years 2, 3 and 4* (%) |
| |
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 |
|
*Combined Years 2-4 |
|
N = 1524 and 1516,
finasteride vs placebo, respectively |
|
