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testosterone replacement therapies 5 articles

FDA OKs new abuse warnings on testosterone replacement therapies, steroids

The Food and Drug Administration (FDA) has approved updated safety label on numerous testosterone replacement therapies to include a new subsection under Warnings and Precautions regarding the risk of abuse. The warning also advises physicians to check serum testosterone concentration in men if testosterone abuse is suspected, to counsel patients of possible serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids (AAS), and to consider the possibility of testosterone and AAS abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. In October, the FDA announced it had ordered the safety label changes to ... Read More

Studies link testosterone treatments to heart problems

It’s hard for some to imagine that testosterone replacement treatments can be linked to cardiovascular risks including heart attacks, strokes, deep vein thrombosis and pulmonary embolism But the risk is real, says ClassAction.org., a group of online professionals who report on legal issues for consumers. According to the report, testosterone replacement therapies, including gels, patches and injections, can increase the amount of red blood cells in the body that can coagulate and cause the blood to thicken. This can make it more difficult for blood to flow through the body, which can lead to high blood pressure and heart problems, including ... 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

FDA to consider review of first oral testosterone product

Just weeks after the Food and Drug Administration (FDA) ordered manufacturers of testosterone replacement therapies to collect data involving cardiovascular risks in patients who used their products, another drug company announced it was seeking FDA approval on a new oral testosterone supplement. Drug maker Lipocine announced it had submitted a new drug application (NDA) to the FDA for LPCN 1021, its experimental twice-daily, oral testosterone treatment. The drug is intended for men with conditions related to a deficiency or absence of endogeneros testosterone, a condition known as hypogonadism. The application for LPCN 1021 includes data from a pivotal Phase 3 clinical ... Read More

Drug makers required to team up on testosterone side effects study

Manufacturers of testosterone replacement therapies have been ordered by the Food and Drug Administration (FDA) to collect testosterone side effects data from men who use their drugs. To help speed up the process, the agency is encouraging the companies to “work together on a single trial.” The FDA request is the latest effort to crack down on the overprescribing of testosterone products. Thanks to heavy direct-to-consumer marketing campaigns by drug makers, prescriptions for “age-related hypogonadism” as opposed to “classic hypogonadism” have skyrocketed. Popular brand-name testosterone replacement therapies include AndroGel, Testim and Axiron. Hypogonadism, in the classic sense, is a condition in which ... Read More