The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 6 in favor and 13 against the benefit/risk profile of Tlando (testosterone undecanoate) capsules.
For short term ibuprofen use the effects of compensated hypogonadism are reversible, however the researchers state how it is unknown whether these effects are reversible for long-term ibuprofen use.
The discontinuation is not due to the safety or efficacy of the drug but due to the the multiple manufacturers that currently provide supply to the U.S. market.
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and for the maintenance of secondary sex characteristics.
"Our results highlight the opportunity to intervene both at the provider and the site level to improve testosterone prescribing," the authors write.
The researchers found that of the 72 subjects taking testosterone, at each visit significant increases in hemoglobin/hematocrit levels and BMI were recorded, as was a decrease in high-density lipoprotein level.
Perrigo has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution, the generic version of Eli Lilly's Axiron Topical Solution.
According to a study published in the Journal of Cardiovascular Pharmacology and Therapeutics, long-term testosterone therapy may have protective cardiovascular (CV) effects in men with hypogonadism.
Chronic pain patients being treated with certain opioid and non-opioid medications had significantly lower serum concentrations of free testosterone (fTe) and free estradiol (fE2), highlighting the potential endocrinologic side effects of these drugs. These were the findings of a new study published in the journal Drug Testing and Analysis.
Antares Pharma announced the submission of a New Drug Application (NDA) for QuickShot Testosterone (testosterone enanthate auto-injector) to the Food and Drug Administration (FDA) to treat males with low testosterone associated with hypogonadism.
Despite initial recognition of opioid-induced androgen deficiency (OPIAD) as a possible consequence of opioid use more than four decades ago, few studies have systematically investigated hormonal changes induced by long-term opioid administration.
Men treated with implantable testosterone pellets have a statistically significant increase in mean hematocrit, but it is unlikely to be clinically relevant, according to research published in The Journal of Urology.
Once-daily 2% testosterone solution (T-sol) is safe and effective for sex drive and energy in hypogonadal men, according to a study published online in The Journal of Urology.
Older men on testosterone therapy were less likely to experience complications requiring hospital readmission within 1 month of discharge than men not using testosterone therapy, according to a study published in Mayo Clinical Proceedings.
Testosterone therapy helped elderly males with low testosterone levels and pre-existing coronary artery disease reduce their risks of major adverse cardiovascular events, including strokes, heart attacks, and death.
The Food and Drug Administration (FDA) announced it is requiring class-wide safety labeling changes for all immediate-release (IR) opioid pain medicines.
Application of once-daily topical testosterone effectively restores normal testosterone levels in men, according to a study published in the March issue of The Journal of Urology.
Testosterone treatment may offer moderate benefit in improving sexual function in older men, but further research is needed to establish possible risks, according to research published in the New England Journal of Medicine.
Exposure to opioids is associated with increased likelihood of low testosterone levels, with increased odds as age and number of comorbidities increase, according to a study published in Pain Medicine.
Acerus announced that its agreement with an affiliate of Endo International plc regarding the commercialization of Natesto (testosterone) nasal gel in the U.S. and Mexico will be terminated as of June 30, 2016.