SIDE EFFECTS Side effects identified in clinical studies: The study halotestin buyfor 4 years evaluated the safety of therapy in 1524 patients treated with ®, compared with 1516 patients taking placebo: 74 patients (4.9%) in the group treated ® therapy has been discontinued due to the occurrence of side effects associated with the drug, compared with 50 patients (3.3%) in the placebo group. 57 patients (3.7%) in the group treated with PROSCAR ® and 32 patients (2.1%) in the placebo group discontinued treatment because of side effects associated with impaired sexual function, which were the most frequently reported side effects.
The only clinical adverse reactions that were considered by researchers as possibly, probably or definitely related to the drug, and the incidence of which while taking the drug ® was more than 1% and higher than that with placebo during the 4 years of the study, were effects associated with impaired sexual function , breast tenderness and skin rash. in the first year of treatment of sexual dysfunction was found in 8.1% of patients in the group taking PROSCAR ® and 3.7% in halotestin buy the placebo group; decreased libido – 6.4% and 3.4%; and abnormal ejaculation – 0.8% and 0.1% respectively. In applying the drug PROSCAR ® for 2-4 years of study the incidence of the above side-effects in patients treated with PROSCAR ® , did not differ significantly from that of patients receiving placebo.
The overall incidence of adverse events during the study was 2-4 years: sexual dysfunction (5.1% in the preparation ® and 5.1% in the placebo group), decreased libido (2.6% in both groups), abnormal ejaculation (0.2% and 0.1%, respectively). Within one year of ejaculate volume reduction was detected in 3.7% and 0.8% in the preparation PROSCAR ® and placebo, respectively; and during 2-4 years of research – 1.5% and 0.5% respectively. During one year and it reported an increase in mammary gland (0.5% and 0.1% respectively), the pain of the breast (0.4% and 0.1%, respectively), and rash (0.5% and 0 and 2% respectively). For 2-4 years, the total frequency of these events was: breast enlargement (1.8% and 1.1%, respectively), pain in the breast (0.7% and 0.3%, respectively), skin rash (0 , 5% and 0.1%, respectively). As a 7-year placebo-controlled study in which 18,882 healthy men were included, according to the results of the biopsy (in 9060 men) prostate cancer was detected in 18.4% patients treated ® and 24.4% of patients receiving placebo. In 280 men (6.4%) in patients treated with ® , and 237 men (5.1%) in the placebo group were diagnosed with prostate cancer, which was estimated based on the results of a puncture biopsy.
Additional analysis suggests that an increase in the frequency of high-grade, observed in patients treated with halotestin buy ® , may be due to diagnostic errors due to the influence of the drug on prostate volume. Approximately 98% of all diagnosed cases of the cancer tumor was classified at the time of diagnosis as an intracapsular (stage T1 or T2). The clinical significance of the results relating to prostate cancer 7-10 Gleason, this study is not known. The study safety and tolerability profile of combined treatment with finasteride 5 mg per day and doxazosin 4 mg or 8 mg per day was comparable safety and tolerability of each of these agents alone. During 4-6 placebo-controlled study using summer MTOPS drug as the active control carried out with the participation of 3047 men were recorded 4 cases of breast cancer in men taking finasteride and no cases in men who were not taking finasteride. During the 4-year placebo-controlled study PLESS, conducted with the participation of 3040 men, it was recorded 2 cases of breast cancer in men receiving placebo, and no cases in men taking finasteride. During a 7-year placebo-controlled study SSBS (Prostate Cancer Prevention Trial, «Research on Cancer Prevention prostate”), conducted with the participation of 18,882 men was recorded 1 case of breast cancer in men taking finasteride, and 1 case of breast cancer prostate in men receiving placebo.
Postmarketing reports were received of cases of breast cancer in men taking finasteride. The relationship between long-term intake of finasteride and the occurrence of breast neoplasia in men is not currently installed. Post-marketing experience with in the post-marketing practice reported the following additional adverse drug effects PROSCAR ® and / or finasteride at lower doses. Since the reports of these reactions have been reported on the principles of voluntariness, for an unknown population size, is not always possible a reliable assessment of their frequency or establish a causal relationship with exposure to the drug. On the part of the immune system: hypersensitivity reactions, including skin itching, hives, swelling of the lips and face. On the part of the mind: depression, decreased libido, which may continue after cessation of treatment. reproductive system and breast: tenderness of the testicles; Erectile dysfunction, which may continue after cessation of treatment; male halotestin buy infertility and / or a decline in the quality of semen. It was reported that after the abolition of finasteride semen quality to normal or improved. Laboratory parameters In assessing the laboratory indicators of prostate-specific antigen (PSA) should take into account the decrease of its concentration in patients treated with PROSCAR ® . Other differences in the levels of standard laboratory parameters between the groups of patients receiving PROSCAR ® and placebo was not observed.