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Low T 116 articles

Dr. K supports doctor’s reluctance to prescribe testosterone replacement therapy

Older men with low-normal testosterone levels should not rush into testosterone-boosting treatments without first considering the risks versus the benefits, said Dr. Komaroff, who goes by Dr. K at AskDoctorK.com, a syndicated health-related column. “I’m a 68-year-old man who has been feeling more tired and less ‘sexy’ over the past several months,” a reader writes, adding that his doctor told him his testosterone levels were “low normal.” “I know that some men take testosterone gel as a treatment (for low testosterone). My doctor is not so keen on that. What’s your opinion?” Dr. K didn’t offer direct advice to the ... Read More

Testosterone replacement therapy expected to grow rapidly around world

The testosterone replacement therapy (TRT) market is expected to grow rapidly around the world despite serious cardiovascluar risks associated with the hormone treatment, according to Transparency Market Research, a firm that provides current market trends and forecasts. Testosterone treatments are designed to boost levels of the hormone testosterone in men who have low testosterone due to injury or disease, a condition known as hypogonadism. It is not intended for men with naturally occurring age-related hypogonadism. The treatment has “gained momentum in the last decade,” according to the market research firm, primarly in the United States thanks to aggressive direct-to-consumer advertising by ... Read More

FDA to consider approval of first oral testosterone treatment

Lipocine Inc., a specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in hopes of gaining approval of the first oral testosterone replacement therapy for adult males with hypogonadism, a condition in which men do not produce enough testosterone due to disease or defect. The FDA says it expects to have its review of the drug, known as LPCN 1021, completed by June 28, 2016. Testosterone treatments are currently available by prescription in topical gels, patches, nasal sprays, and injections. Oral versions of the hormone have been difficult to formulate because the ... Read More

Federal judge allows generic testosterone lawsuits to move forward

A U.S. District Judge says thousands of lawsuits in multidistrict litigation (MDL) can more forward with claims that manufacturers of generic testosterone replacement therapies fraudulently promoted the hormones for off-label use. The ruling partially reverses a November decision that those claims were preempted along with others regarding the adequacy of the products’ labeling. Testosterone treatments are approved by the Food and Drug Administration (FDA) to treat hypogonadism, a condition in which men do not produce enough testosterone due to injury or disease. The lawsuits claim that manufacturers of testosterone supplements marketed their drug for a different condition, which they coined ... Read More

Legislation calls to end tax breaks for drug makers direct-to-consumer advertising

Sen. Al Franken (D-Minn.) is introducing legislation to end the tax break for drug makers who participate in direct-to-consumer advertising in an effort to encourage drug companies to focus on developing new drugs instead of “marketing schemes” to drive up profits. The move comes two weeks after Rep. Rosa DeLauro (D-Conn.) introduced a bill that would place a three-year moratorium on advertising newly approved prescription medications to consumers, and four months after the American Medical Association called for a ban on direct-to-consumer advertising. Franken argued that this form of marketing increases the price of prescription drugs and the ads “encourage ... Read More

Charlie Sheen claims testosterone therapy caused his bizarre behavior

Charlie Sheen has been no stranger to the limelight since he revealed last November on the Today show that he was HIV positive. This week on Dr. Oz, Sheen revealed another health mystery – he says his bizarre behavior in 2011, in which he claimed to be “winning” while calling himself a “warlock” with “Adonis DNA,” was actually caused by the overuse of topical testosterone cream. “I was taking a lot of testosterone cream and I think I went too far with it,” Sheen told Dr. Oz in an interview taped for the Feb. 24 show. Testosterone replacement products are ... Read More

Insurer claims testosterone therapy makers deceived patients, doctors, insurers

An Ohio-based health insurer is accusing a group of drugmakers of federal racketeering and fraud for alleged “fraudulent marketing schemes” to boost sales of testosterone treatments by “deceiving patients, primary care physicians, and third-party payers about the drugs’ safety and efficacy for treating certain conditions,” thus gouging the insurer and other third-party payers. The lawsuit names Abbvie, Solvay Besins, GlaxoSmithKline, Eli Lilly, Activis and other manufacturers of testosterone replacement therapies. Medical Mutual of Ohio (MMO) claims that the drug companies’ misrepresentations led it and other third-party payers to reimburse payments for purportedly “medically inappropriate (testosterone) prescriptions,” the complaint states. U.S. ... Read More

European group issues statement regarding use of testosterone replacement therapy

Recent controversy in the United States regarding the overprescribing of testosterone replacement therapy to aging men, and cardiovascular side effects associated with the hormones, have prompted the European Menopause and Andropause Society (EMAS) to issue a statement saying testosterone treatments should not be offered to all aging men, and that candidates be evaluated for co-morbidities that could affect natural testosterone levels and increase side effects from treatment. Testosterone treatments, which includes the brand names AndroGel and Axiron, are intended for men who suffer from hypogonadism, a condition in which men do not produce enough testosterone due to disease or injury. ... Read More

Physicians group calls for ban of drug ads aimed at consumers

The American Medical Association (AMA) is calling for an end to pharmaceutical companies’ direct-to-consumer advertising, saying the billions of dollars spent each year on the ads lead consumers to demand prescriptions that are often unnecessary and potentially dangerous. The AMA, which represents about a quarter of a million physicians nationwide, voted this week to take action against drug companies that heavily promote their treatments to consumers, arguing that such advertisement “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate,” said AMA board chair-elect Patrice Harris in a statement. Case in point, manufacturers of ... Read More

Victims of testosterone side effects want their day in court

Robert Knapik felt tired and rundown, so much so he asked his doctor what could be causing the symptoms. His doctor diagnosed him with low testosterone, and suggested testosterone replacement therapy might help. It nearly killed him. After using the testosterone treatment Axiron, made by Eli Lilly & Co., for three months, Knapik began feeling pain in his arm and chest. He was later diagnosed with a heart attack. He learned that recent research had revealed that men who used testosterone replacement products were at an increased risk of blood clots, heart attacks, and strokes. Some users have even died. ... Read More