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. However, there were concerns raised about Aveed’s side effects including injection site reactions (it is an injectable drug) and blockages in the blood vessels in the lungs. The FDA takes the recommendations of its advisors into account when determining whether to approve a drug for marketing in the United States.
Aveed already faces an uphill battle. Consumer watchdog group Public Citizen this week urged the FDA to delay its decision on the product until its review on heart risks with testosterone drugs is completed. The agency recently launched the investigation after studies and analyses indicated that use of testosterone replacement products increased the risk of heart attacks, strokes and death. Older men and men with heart disease were shown to be particularly vulnerable to cardiovascular events, with some studies showing increased heart risks of one third to one half greater compared to men who did not use the drug.