Tagged Articles

Aveed 7 articles

FDA approves long-acting testosterone with black box warning

A new long-acting testosterone therapy has been approved by the Food and Drug Administration (FDA), but the approval comes with a black box warning and strong prescribing restrictions. Aveed, made by Endo Pharmaceuticals, is a long-acting depot formulation of testosterone in caster oil and benzyl benzoate. It is administered in a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at four weeks after initiation of treatment, and then every 10 weeks thereafter. Aveed is approved to treat hypogonadism, a condition in which men produce too little of the hormone due to disease or defect. The FDA required ... Read More

FDA approves new warning label for testosterone replacement treatments

The safety labels of prescription testosterone replacement products warning of cardiovascular risks have been updated and approved by the Food and Drug Administration (FDA). The products include gels, patches, topical solutions, nasal sprays and injections. Brand names include: Androderm AndroGel Aveed Axiron Delatestryl Fortesta Natesto Striant Testim Testosterone Gel Vogelxo The new warning is listed under Warnings and Precautions and Adverse Reactions sections, and states, “Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk ... Read More

New blood clot warning added to safety labels of testosterone replacement therapies

The safety labels of testosterone replacement treatments have been updated to include warnings of an increased risk of life threatening blood clots. The update comes on the heels of a Food and Drug Administration (FDA) safety alert notifying the public that during an ongoing investigation into cardiovascular risks with testosterone treatments, researchers uncovered a number of reports of thromboembolic events, or blood clots, in men using the hormone replacement products. The new warnings were added to the labels of the following testosterone therapies: Androderm transdermal system, AndroGel gel (1% and 1.62%), Aveed injection, Delatestryl injection, Fortesta gel, Striant buccal system, ... 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 approves long-lasting injectable testosterone therapy despite protests

The Food and Drug Administration (FDA) has approved a new long-lasting testosterone treatment for men despite protests from consumer watchdog Public Citizen to delay it’s decision until the agency has had a chance to review studies that show testosterone replacement therapy increases the risk of heart attacks, strokes and death. The new treatment, AVEED, made by Endo Pharmaceuticals, is an injection that is administered as a single 3mL (750 mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It will be available as a prescription this month. The drug is intended ... Read More

Controversy surrounds upcoming FDA decision on long-acting testosterone drug

The Food and Drug Administration (FDA) is expected to decide this week the fate of a long-acting testosterone product made by Endo Health Solutions, Inc. Aveed, indicated to boost testosterone in men with low levels of the hormone, has been rejected by the agency twice before based on health risks. Aveed, sold in other countries under the brand name Nebido, received mixed reactions from FDA advisors last year. The panel was split 9-9 on whether to recommend approval of the drug. Some advisors said the drug offers a valuable alternative to existing shorter-acting products, such as AndroGel, Testim and Axiron. ... Read More

Public Citizen urges FDA to add warnings of heart attack, stroke, death to testosterone treatments

Consumer advocacy group Public Citizen is petitioning the Food and Drug Administration (FDA) to require manufacturers of testosterone treatments to add black box warnings on the labels about the increased risk of heart attacks, stroke and death in men who use the treatment. Black box warnings are the strongest given by drug regulators and signify that medical studies indicate that a particular drug carries a significant risk of serious or even life-threatening adverse events. Testosterone supplements, including AndroGel, Testim and Axiron, are approved by the FDA to treat hypogonadism, a medical condition in which the testes produce little to no testosterone. ... Read More