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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

Hundreds of Georgia elementary kids accidentally given two flu shots

Nearly 400 Bibb County, Georgia, students were accidentally given two flu shots during a campaign to inoculate children against seasonal influenza. North Central Health officials were tipped off by a parent who said his child had received a flu shot at school when he had already been given one previously. This prompted an audit that found 383 elementary school students unnecessarily received a second dose of the flu vaccine. Health officials blame the accident on paperwork oversight and said the school will not be charged for the extra shots. The district also says there is no cause for alarm. “We ... Read More