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testosterone 59 articles

First testosterone trial begins

More than 2,000 plaintiffs from around the U.S. will be watching this week as the first testosterone trial gets underway in Chicago, according to the Cook County Record. It is the first of seven cases in the class action singled out as bellwethers. Thousands of plaintiffs filed suit against multiple drug manufacturers of testosterone replacement drugs saying the drugs increased their risk of life-threatening adverse effects including blood clots, stroke and heart attack. As Beasley Allen previously explained, the U.S. Judicial Panel on Multidistrict Litigation established a multidistrict litigation (MDL) for testosterone replacement drugs in 2014 following a Food and ... Read More

Testosterone side effects could slow sales of testosterone replacement therapy products

Concerns of testosterone side effects, particularly the cardiovascular risks associated with testosterone replacement therapies, could slow skyrocketing sales of the drugs, analysts predict. Testosterone treatments are used to treat low testosterone levels in men due to injury or defect, a condition known as hyopgonadism. The drugs, which include the widely prescribed Androgel and Testim, have been heavily promoted by drug companies in recent years, asking men if they suffered from low libido, weight gain, fatigue and muscle loss – symptoms that could suggest low testosterone levels, a condition these drug companies named “Low T.” In response, men marched into doctors’ offices asking ... Read More

Physician warns men to consider testosterone replacement therapy side effects

Dr. Gerald Chodak is advising men who are considering going on testosterone replacement therapy to be aware of the known side effects and the unknown side effects with the drugs. Dr. Chodak published his warning on Medscape, a web resource for physicians and health professionals. Testosterone treatments, such as AndroGel, Axiron and Testim, are FDA-approved to treat men with a condition in which an injury or disease prevents them from producing enough testosterone. This can result in symptoms such as low sex drive, muscle loss, weight gain, and fatigue. However, pharmaceutical companies that sell testosterone treatments have launched aggressive marketing campaigns in ... Read More

Women should not be treated with testosterone therapy, Endocrine Society advises

Low testosterone is not a valid diagnosis in healthy women, and most women with low amounts of the hormone should not use testosterone-replacement drugs, the Endocrine Society said in a new guideline. “Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” guideline task force chair Dr. Margaret Wierman, of the University of Colorado, said in news release. Dr. Wierman said that in a review of past studies, women who had low testosterone levels did not exhibit any signs ... Read More

FDA panel recommends severely limiting testosterone drug prescriptions

A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

The U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.” FDA officials added briefing documents to the agency website earlier this month, acknowledging that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, such as testicular and pituitary disease. Still, as the agency notes, testosterone ... Read More

Increased testosterone levels trigger aggression in male brain

Testosterone, the steroid hormone, has long been linked to aggressive behavior in men but, until now, it has been unclear the neural circuits through which testosterone exerts these effects. New research has identified for the first time that increasing levels of testosterone within the normal physiological range can have a profound effect on brain circuits that are that trigger threat-processing and human aggression. Researchers, led by Dr. Justin Carre, studied brain structures that mediate threat processing and aggressive behavior, which included the amygdala, hypothalamus, and periaqueductal gray. The team recruited 16 healthy young male participants for the two-day study. Before the ... Read More

Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Canada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels. Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.” As in the U.S., men ... Read More

Testosterone drugs may seriously harm some patients, doctor warns

National Public Radio (NPR) recently called testosterone replacement drugs “the biggest men’s health craze since Viagra,” but some doctors warn that the supplements could be anything but healthy for some men. The Louisiana State University (LSU) Health Sciences Center in New Orleans recently reported that resident urologist Harold Fuselier warns that testosterone-replacement drugs, which are now widely available in topical gels, creams, and patches, could have serious, even deadly, side effects. It’s an especially important warning to consider, given the proliferation of television, web, and print advertisements touting the advantages of drugs that artificially boost low testosterone levels, often referred ... Read More

FDA sued for failure to publish approval of generic testosterone drug

Multinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone gel product, even though it had received FDA approval. Ireland-based Perrigo, the largest manufacturer of private label over-the-counter prescription drugs in the United States, said that the FDA failed to update its “Orange Book” listing Approved Drug Products with Therapeutic Equivalence Evaluations. As a result, Perrigo’s testosterone-replacement gel, a generic equivalent of AbbVie’s AndroGel, is not included in the FDA’s therapeutic equivalents (TE) – ... Read More