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Abbott Laboratories. Abbott 25 articles

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

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

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