Tagged Articles

hypogonadism 15 articles

FDA orders drug makers to conduct testosterone supplments side effects studies

The Food and Drug Administration (FDA) is asking manufacturers of testosterone supplements to hold clinical trials of their testosterone replacement treatments marketed to older men to help boost low levels of the hormone. The agency wants to know how men lured by advertising campaigns for testosterone products fared after taking the drugs, especially since data shows that a large number of those who were prescribed the treatments were never tested to determine if they actually had low levels of testosterone in their blood. Testosterone replacement therapies are designed to boost the hormone in men who suffer from hypogonadism, a condition ... Read More

Low T linked to depression, but testosterone side effects could be dangerous

Men who have low levels of testosterone are more likely to be depressed than men in the general population, a new study has found. But testosterone levels should be checked before testosterone replacement therapy is begun to help prevent potentially serious side effects. Researchers from George Washington University reviewed medical records and surveys of 200 men between the ages of 20 and 77 who were being treated for low levels of testosterone, a condition known as hypogonadism. They found that more than half of these men – 56 percent – reported being depressed or having symptoms of depression. About 25 ... Read More

Doctors warn against overprescribing of testosterone treatments

“Why are so many people taking testosterone for an unapproved use?” ask Steven Woloshin and Lisa M. Schwartz, professors of medicine at the Dartmouth Institute for Health Policy and Clinical Practices in a Washington Post opinion piece titled, “Sell a disease to sell a drug.” Woloshin and Schwartz are co-chairs of the steering committee of Preventing Overdiagnosis, an international conference that will be held in September at the National Institutes of Health. While the overprescribing of medication can be seen with many types of medications, from painkillers to antidepressants, Woloship and Schwartz’s column focuses on the overuse of testosterone replacement ... Read More

FDA: Only men with specific medical conditions should take testosterone

The Food and Drug Administration (FDA) is ordering makers of testosterone replacement treatments to change the labeling to better clarify that only men with specific medical conditions should take the drugs. Drug companies will also be required to add information about potential heart attack, stroke and death risks associated with use of the drugs. The FDA order comes after a hefty surge of prescriptions for testosterone products, a likely result from aggressive marketing campaigns aimed at consumers from drug companies eager to capitalize on the natural drop of testosterone as men age. In younger men, this condition is known as ... Read More

Doctors reluctant to prescribe testosterone therapy

Doctors are more reluctant to prescribe testosterone therapy to male patients than they were years ago, according to an international survey of endocrinologists. The study was designed to document current practices in the approach to low testosterone in older men. “Given that recommendations are based on low-level evidence, we hypothesized that there would be a wide variety in clinical practice patterns,” researchers wrote. The web-based survey was completed by 943 physicians from North America, Europe, Oceania, Latin America, the Caribbean, the Middle East, Asia and Africa. “There was a wide variability in clinical practice patterns,” researchers wrote. “A total of ... Read More

New Jersey man blames heart attack on Axiron testosterone treatment

New Jersey resident Patrick Miller was 54 when he started using Axiron, a testosterone replacement product used to treat men who have low levels of the hormone in their blood. A month later, on Oct. 3, 2012, he had a heart attack. Thirteen months later, the Journal of the American Medical Association (JAMA) published a study that found men who used testosterone treatments have a 30 percent increased risk of having a heart attack, stroke or dying. And, in January 2014, the journal PLOS One found a two-fold increased risk of heart attack among older men in the first 90 days ... Read More

Experts: testosterone treatments vastly overprescribed

Nearly 3 percent of American men aged 40 and older – about two million men – received prescriptions for testosterone replacement treatments in 2011 – three times more than a decade earlier, raising concerns that the drugs may be overprescribed. Testosterone therapy is intended for men who suffer from low testosterone levels, a condition known as hypogonadism, caused by damage or disease in their testes or other parts of the endocrine system. This can cause symptoms such as low sex drive, muscle loss, weight gain and fatigue. Testosterone levels typically drop as a man ages. But many middle-aged and older ... Read More

Testosterone levels tend to fluctuate significantly in younger men but remain more constant in older men

Most schools of thought suggest that measuring testosterone levels in men can be tricky because the hormone levels vary from day to day as well as hour to hour. However, a new study finds that only young men experience statistically and clinically significant fluctuations in testosterone levels. Researchers studied records of more than 2,500 men ages 26 to 84 who had their testosterone levels checked at an erectile dysfunction clinic. The men were sorted into five age groups, beginning with 26- to 39-year-olds. Each of those groups were divided into sub-groups depending on the time of day their testosterone was ... Read More

Long-term safety of testosterone treatment remains questionable

Current prescribing practices for testosterone therapy constitute abuse, said Ajay Nangia MD, with the University of Kansas Medical Center in Kansas City, during the first-ever “Crossfire” session at the American Urological Association meeting. Nangia was pitted against Martin Miner, MD, with Brown University in Providence, RI. A surge in testosterone supplement prescriptions in the past few years and recent studies questioning the safety of the therapy have made the hormone treatment a hot topic in some medical circles. Low testosterone levels can lead to symptoms such as a low sex drive, weight gain, fatigue and muscle loss. While testosterone levels drop ... Read More

Drug company anticipates launch of new oral testosterone treatment

Clarus Therapeutics, an emerging men’s health specialty pharmaceutical company, filed with the Securities and Exchange Commission (SEC) this week to raise up to $86 million in an initial public offering. The biotech company is preparing for the commercial launch of REXTORO, an oral testosterone replacement therapy for which the company has submitted a New Drug Application with the Food and Drug Administration (FDA). If approved, REXTORO will be the first oral testosterone treatment available in the United States. The drug is intended to boost testosterone levels in men with low testosterone levels, also known as hypogonadism. The term “Low T” ... Read More