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Testim 98 articles

Repros enrolls men to test new topical testosterone treatment Androxal

Repros Therapeutics Inc. announced it has completed enrollment for one of two clinical trials pitting its topical testosterone gel alternative Androxal against other topical testosterone products currently on the market. Each trial will include 120 men, who will be divided into groups of 40 for three parallel study arms to test Androxal against an already marketed testosterone gel and a placebo. Studies will run for 17 weeks, which includes 16 weeks of dosing and one week of follow-up to gather information for the conclusion. Repros sought men who were at least 60 years of age who exhibited a normal sperm count ... Read More

Study: Low T contributes to more satisfying relationships

Low testosterone levels in men have been blamed for a variety of symptoms – from low sex drive and mood swings to weight gain and muscle loss. But a new study shows that low testosterone has its benefits. It may actually contribute to more romantic and satisfying relationships. “The assumption is generally that high testosterone is good for sexual relationships,” says Robin Edelstein, associate professor of psychology with the University of Michigan. Edelstein and her team set out to put that notion to the test. They surveyed 39 heterosexual couples between the ages of 18 and 39 who were in relationships ... Read More

Doctor raises red flags regarding heart risks with testosterone therapy

Testosterone replacement therapy may sound attractive with ads promising to build muscle mass and boost libido, but Low T therapy may not be all that it’s cracked up to be, warns Dr. Joe Littlejohn, a urologist at Orlando Health. It could be deadly. If you listen to the advertisements from drug companies pushing testosterone products, such as AndroGel, Testim and Axiron, the therapy can help men feel decades younger. Though testosterone levels drop naturally as men age, these supplements can help men turn back the clock. What’s not to love? New research, however, has raised some serious red flags that ... Read More

European drug regulators investigating heart attack, stroke, death risks with testosterone therapies

The European Medicines Agency (EMA) is reviewing the safety of testosterone therapy after studies showed the treatment increases the risk of strokes, heart attacks and death. The announcement comes three months after the U.S. Food and Drug Administration (FDA) launched a similar investigation into the drugs. Testosterone supplements are prescription medications given to men with low testosterone levels. The drugs are used to treat symptoms of “Low T” such as fatigue, muscle loss, weight gain and low sex drive. The drugs are available in capsules, implants for under the skin, patches or topical gels. Brand names include Testim, Androgel and Axiron. ... Read More

Group with drug maker ties pushes for retraction of paper linking testosterone therapy to heart problems

The Androgen Study Group, a newly formed multidisciplinary group of clinicians and researchers focused on the science of testosterone deficiency in men and its treatment, is calling for the retraction of a paper published in the Journal of the American Medical Association (JAMA) that linked testosterone replacement therapy to an increased risk of heart attacks, strokes and death. In a letter to JAMA editor-in-chief, the group claims that the study the paper was based on was compromised and should be removed from the journal. The paper by Michael Ho, MD, PhD focused on a study that found a higher rate ... 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

Drug company sues FDA for dragging feet on testosterone gel marketing approval

Perrigo Israel Pharmaceuticals has filed a lawsuit against the Food and Drug Administration (FDA) alleging the company failed to update its records to show its approval of the company’s testosterone gel. Perrigo’s generic version of AbbVie’s AndroGel was approved by the FDA in February 2013. The company cannot market the product until the FDA registers it with Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. Under the FDA act, the agency is required to publish approved drugs with therapeutic equivalence information and update the Orange Book every 30 days. The lawsuit states that Perrigo made ... 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

Alabama man files testosterone side effects lawsuit after suffering stroke

An Alabama man has filed a lawsuit against the makers of the testosterone replacement treatment Testim, claiming the drug caused him to have a stroke. Robert Hoehl, 64, had no history of cerebrovascular disease or neurological impairments when he began the hormone therapy in the fall of 2011. Less than a year later, he had a stroke. He immediately stopped taking Testim. Doctors noticed he had elevated hematocrit levels, a condition that can increase the risk of blood clots, heart disease and stroke. Hoehl’s blood levels were checked on a regular basis. Within months after quitting Testim, his hematocrit levels ... Read More

Philadelphia man claims Testim testosterone treatment gave him a heart attack

A 67-year-old Philadelphia man with no history of cardiovascular problems has filed a lawsuit against the makers of his testosterone replacement product claiming the drug caused him to suffer a heart attack. The lawsuit states that the injury was caused by the “exogenously administered testosterone-containing Testim,” a prescription drug made by Auxilium Pharmaceuticals and GlaxoSmithKline. Edwin Rios had been using Testim for a year when he had the heart attack. Testosterone replacement products are designed to boost the hormone’s levels in men who are experiencing symptoms of low testosterone such as weight gain, mood swings, and low libido. Testim was ... Read More