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Auxilium Pharmaceuticals 39 articles

Testosterone Replacement Therapy trial requires Doc to reveal payments

A Boston-area doctor notorious for pushing testosterone replacement therapy to his patients for the past three decades was ordered to turn over his tax records indicating how much money he was paid by manufacturers of testosterone drugs. The order was made by U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois regarding a multidistrict litigation (MDL) accusing testosterone replacement therapy manufacturers of promoting testosterone treatment for so-called Low T without revealing that use of the hormone can cause serious medical problems, including life threatening heart attacks, strokes and blood clots. AbbVie is in the hot seat for ... Read More

Drug makers sued over testosterone side effects support mass tort status

A group of testosterone treatment manufacturers are supporting a motion filed by plaintiffs suing the drug makers over testosterone side effects to create a new mass tort program in Pennsylvania state court. The motion would consolidate about 30 pending cases in order to ease discovery and allow for better coordination with attorneys handling a related multidistrict litigation (MDL) in Illinois federal court. Both the plaintiffs and defendants agreed that the consolidation made sense from a practical perspective. The motion was filed in Philadelphia County Court of Common Pleas. Defendants include AbbVie Inc., Endo Pharmaceuticals, Inc., and GlaxoSmithKline LLC. The lawsuits ... 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

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

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

More lawsuits filed against makers of testosterone replacement therapies

Makers of testosterone treatments are being slapped with lawsuits following studies that show use of the products increases the risk of cardiovascular events. The latest lawsuits to be filed name Auxilium Pharmaceuticals and GlaxoSmithKline, makers of Testim, as well as Abbott Laboratories and AbbeVie, makers of AndroGel. A lawsuit filed by Robert Olivetti and his wife Marion allege that Mr. Olivetti’s use of Testim and AndroGel caused him to have a heart attack, which led to a coronary bypass. Edwin Rios and wife Eileen lawsuit claim Mr. Rios’ use of Testim caused his heart attack. The plaintiffs say the drug ... Read More