Testosterone medicines

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. As testosterone-containing medicines are all authorised nationally, the PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position. The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.

Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men. In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function. Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men. Possible signs and symptoms include incomplete sexual development, decreased sexual function, infertility, fatigue, depressed mood, mild anaemia, reduced muscle bulk and strength and increased body fat.

Adverse effects of testosterone supplementation may include increased cardiovascular events (including strokes and heart attacks ) and deaths based on three peer-reviewed studies involving men taking testosterone replacement. [51] In addition, an increase of 30% in deaths and heart attacks in older men has been reported. [52] Due to an increased incidence of adverse cardiovascular events compared to a placebo group , a Testosterone in Older Men with Mobility Limitations (TOM) trial (a National Institute of Aging randomized trial) was halted early by the Data Safety and Monitoring Committee . [53] On January 31, 2014, reports of strokes , heart attacks , and deaths in men taking FDA-approved testosterone-replacement led the FDA to announce that it would be investigating the issue. [54] Later, in September 2014, the FDA announced, as a result of the "potential for adverse cardiovascular outcomes", a review of the appropriateness and safety of Testosterone Replacement Therapy (TRT). [55] [56] [57] The FDA now requires warnings in the drug labeling of all approved testosterone products regarding deep vein thrombosis and pulmonary embolism . [58]

Analysis of serum testosterone concentrations from 117 hypogonadal men in the 84-week clinical study of Aveed indicated that serum testosterone concentrations achieved were inversely correlated with the patient's body weight. In 60 patients with pretreatment body weight of ≥ 100 kg, the mean (±SD) serum testosterone average concentration was 426 ± 104 ng/dL. A higher serum testosterone average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum testosterone concentrations.

Testosterone medicines

testosterone medicines

Analysis of serum testosterone concentrations from 117 hypogonadal men in the 84-week clinical study of Aveed indicated that serum testosterone concentrations achieved were inversely correlated with the patient's body weight. In 60 patients with pretreatment body weight of ≥ 100 kg, the mean (±SD) serum testosterone average concentration was 426 ± 104 ng/dL. A higher serum testosterone average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum testosterone concentrations.

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