Tagged Articles

reactions 52 articles

Mortality rates lower in older men with moderate testosterone levels, study finds

Older men with testosterone levels in the middle range tend to live longer than men with levels of the hormone that are either too low or too high, a new Australian study has found. The study, published in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM), underscores some of the dangers men may face when they use testosterone replacement drugs to boost hormone levels that aren’t chronically low. According to the study’s lead author Dr. Bu Beng Yeap of the University of Western Australia, when testosterone is metabolized by the body, it produces dihydrotestosterone (DHT), a natural chemical linked to ... 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

Five years of Actos likely caused plaintiff’s terminal bladder cancer, doctor testifies

A University of Chicago Medical Center urologist told a Los Angeles jury last week that Takeda Pharmaceuticals’ type-2 diabetes drug Actos was “the most substantial causative factor” in a California man’s development of terminal bladder cancer. The doctor’s testimony was part of the first product liability case against Takeda to go to trial over injuries allegedly caused by the blockbuster drug. Plaintiff Jack Cooper, a 79-year-old San Diego area resident, sued Japan-based Takeda after taking Actos for a five-year period from 2006 to 2011. His lawsuit against Takeda was selected as the first of more than 3,000 similar cases to ... 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

New Actos lawsuit accuses Takeda of inadequately stating, concealing drug’s risks

A Minnesota man has filed a lawsuit against Takeda Pharmaceuticals and Eli Lilly and Company for injuries he allegedly received as a result of taking the diabetes drug Actos (pioglitazone). The plaintiff, one of the latest to join the Actos litigation consolidated in federal court in Lafayette, Louisiana, claims the type 2 diabetes drug caused him to develop bladder cancer. He seeks damages for permanent injuries, severe mental and physical pain and suffering, and economic losses related to his medical expenses and the costs of maintaining a change in lifestyle brought about by his injuries. Like many plaintiffs who allege ... Read More

Abbott’s new testosterone test gets FDA clearance

The U.S. Food and Drug Administration (FDA) has approved a new method of analyzing testosterone levels in men and women. The new chemical analysis is made by Abbott Laboratories, the drug maker whose sales of Androgel testosterone-replacement gel achieved blockbuster status in recent months, earning the company nearly $900 million in 2011. According to Abbott, its new testosterone assay should help doctors more accurately measure testosterone levels, which vary widely in both men and women. Abbot reported on its website that published studies have demonstrated that many testosterone tests currently used are not sufficiently sensitive to accurately measure low testosterone ... Read More

First Actos bladder-cancer claim against Takeda headed to trial in February

The first lawsuit against Takeda Pharmaceuticals and related companies over Actos injuries will be heard February 19 in Los Angeles Superior Court. In that case, Mississippi resident Jack Cooper alleges that he developed bladder cancer as a result of taking Actos to treat his type 2 diabetes. Mr. Cooper filed his lawsuit in California, where Japan-based Takeda keeps its North American headquarters. Because it will be the first Actos case to go to trial, Mr. Cooper’s lawsuit will serve as a bellwether for potentially thousands of other such cases filed throughout the country. A recent Business Week report estimates the number of ... 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

Court overturns FDA’s decision barring Watson from making generic Actos

Prescriptions of Takeda Pharmaceutical’s blockbuster diabetes drug Actos (pioglitazone) have plummeted since a number of clinical studies linked the drug to a significantly higher risk of bladder cancer in patients, but those safety concerns haven’t dissuaded a group of other drug makers from fighting over the rights to make their own generic versions as Takeda’s Actos patent expires. On Monday, U.S. District Judge Amy Berman Jackson in Washington overturned the U.S. Food and Drug Administration’s (FDA) decision to bar Watson Pharmaceuticals from joining a period of shared exclusivity the agency grants to companies that are first to file for the ... Read More