Tagged Articles

Auxilium Pharmaceuticals 39 articles

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

FDA approves Endo’s new Aveed testosterone injections

U.S. drug regulators gave Irish drugmaker Endo Pharmaceuticals the green light to manufacture and market its long-lasting testosterone injection Aveed in the United States, making it the latest addition to a growing list of testosterone-replacement therapies drug companies are aggressively marketing to men in the U.S. and other countries. Endo Pharmaceuticals said the U.S. Food and Drug Administration (FDA) approved Aveed to treat men with hypogonadism, commonly referred to as “low testosterone” or “low T,” a condition in which the body produces lower than normal levels of the hormone. Men with abnormally low testosterone levels often experience declines in muscle, ... Read More

FDA reassessing testosterone drug safety

The U.S. Food and Drug Administration (FDA) said it plans to review the safety of testosterone replacement drugs after two separate studies indicated a higher risk of adverse cardiac events in men who used the products, including one report that linked the drugs to a doubled risk of heart attack. The agency said it is issuing the alert as it continues to “evaluate the information from these studies and other available data” that point to a significantly higher risk of “stroke, heart attack, and death in men taking FDA-approved testosterone products,” but advised that patients should not stop taking testosterone-enhancing ... Read More

Direct-to-consumer advertising likely inflating demand for testosterone drugs, new study finds

Testosterone replacement therapy for men increased in the U.S. and the U.K. between 2000 and 2011, but whereas supplementation rates quadrupled in the U.S. during that time, they rose just 30 percent in the U.K., according to a new study published in the Journal of Clinical Endocrinology & Metabolism. One likely explanation for the drastically different rates of low-testosterone treatment in the U.S. compared to the U.K. is the prevalence of direct-to-consumer (DTC) advertising in the U.S. DTC advertising has been legal in the U.S. since 1982, but few drug makers took that marketing approach due to requirements about disclosing ... Read More

Adverse health reports for testosterone drugs could fuel advertising

Earlier this month, the Journal of the American Medical Association (JAMA) published a report that cast doubts about the safety of testosterone-replacement drugs for men who take them to boost their levels of the hormone. But with so many pharmaceutical drug companies vying for a larger share of the extremely lucrative but fiercely competitive testosterone drug market, don’t expect all the “Low-T” advertising to slow down until more is understood about the drugs. Indeed, reports of adverse events linked to the drugs may fuel the need for some manufacturers relying on testosterone sales to ramp up advertising campaigns. The latest ... Read More

FDA panelists conflicted on approval of long-lasting testosterone injection

A U.S. Food & Drug Administration (FDA) panel was split on its opinion about the safety of a long-lasting testosterone injection submitted for approval, with nine members backing the drug and nine saying that it’s still too risky to put on the market. Endo Health Solutions, which first submitted its drug AVEED (testosterone undecanoate) for FDA approval in 2007, designed the drug to be in injected once every 10 weeks for the treatment of abnormally low testosterone caused by damage to the reproductive system or hormonal organs from disease or injury. Low testosterone, or hypogonadism, can cause muscle loss, lack ... Read More

Charlie Sheen blames crazy behavior on testosterone drugs

Charlie Sheen will probably spend the rest of his life trying to explain his public meltdown in 2011 after a night of drugs, porn stars, and rage landed him in the hospital. In interviews about that infamous night and other personal and professional troubles, Mr. Sheen has claimed he is a “warlock” with “tiger’s blood” and a “total bitchin’ rock star from Mars” whose brain “fires in a way that’s maybe not from this terrestrial realm.” But in a recent interview, Mr. Sheen claimed to know the real reason behind his psychotic behavior: testosterone cream. “Were you under the influence ... Read More

Only two percent of men should receive synthetic testosterone, researcher say

Testosterone levels in men often diminish with age, leading to a decrease in muscle mass and strength that can leave men frail and less mobile. Other side effects of low testosterone levels, or “low T” as the condition is called by drug marketers, can include diminished energy and sex drive. To restore their overall vitality, aging men and others just seeking a hormonal boost for recreational purposes are turning to synthetic testosterone replacement drugs in record numbers. Abbott Laboratories, which produces the topical hormone drug AndroGel, and Auxilium Pharmaceuticals, the maker of a similar drug called Testim, are all too ... Read More

Obese teen boys have radically low testosterone levels, study finds

It’s no mystery that obese teenage boys are at a heightened risk of developing diabetes and heart disease, but a new study published last week in the journal Clinical Endocrinology found that obese boys have alarmingly low testosterone levels as well – between 40 to 50 percent less than males of the same age with a normal body mass index (BMI). The study, conducted by researchers at the University of Buffalo, builds on earlier research the same scientists completed in 2004, which discovered low testosterone levels (hypogonadism) in older obese males ages 18 to 35, both diabetic and non-diabetic. Dr. ... Read More

Maryland man receives 5-year sentence for illegally distributing AndroGel

A Hagerstown, Maryland, man was sentenced to serve 366 days in a state prison Thursday after he pleaded guilty to illegally distributing AndroGel, a topical testosterone replacement drug made by Abbott Laboratories. According to the Herald-Mail, a Circuit Court Judge sentenced Timothy Allen Feigley, 33, to five years in state prison – the maximum sentence for distributing a Schedule III controlled dangerous substance, but suspended all but one year and one day. Mr.  Feigey also received credit for 139 days he already served. Additionally, Mr. Feigley will be put on probation or three years upon his release. The state dismissed ... Read More