FDA panelists conflicted on approval of long-lasting testosterone injection

androgel pump 435x435 FDA panelists conflicted on approval of long lasting testosterone injectionA 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 of energy, depression, fatigue, and loss of sex drive in men, usually as the result of aging. A number of drug companies are aggressively marketing testosterone-replacement drugs, many of which are available in the form of topical creams of gels.

The number of testosterone drug prescriptions has increased by 90 percent within the last five years, and are expected to triple or quadruple within the next three years. Current sales of testosterone drugs top $2 billion annually.

The FDA first rejected Aveed in 2008 over safety concerns. Endo submitted it for approval again in 2009 and the FDA rejected it then as well. The FDA panelists who voted against approval said that the risk of the hormone supplement in a long-lasting injection formula exceeded potential benefits.

In its latest rejection of the drug, the FDA panel cited allergic reactions and micro embolisms, two risks revealed by Endo’s clinical studies of Aveed. An allergic reaction could involve severe skin disorders, difficulty breathing, and loss of consciousness. Embolisms caused by droplets of oil from the injection traveling to the lungs could result in serious breathing problems.

Testosterone-replacement drugs can be taken in a number of ways. Injections of the drug are currently available but must be taken frequently. Skin patches worn on the upper arm or shoulder deliver the hormone transdermally, while mouth patches offer a continuous release through the oral tissues into the blood.

Gels, such as Androgel and Testim, are growing in popularity because they’re convenient and easy to use.  However, applied to the upper arm or shoulder, topical testosterone drugs can expose women and children to the hormone through contact with the user’s skin or clothing, potentially leading to excessive hair growth and distribution, acne, aggression, premature sexual development, enlarged genitals, and other adverse reactions.

Although the FDA isn’t required to follow the panel’s recommendations on a new drug, it normally does.


Food and Drug Administration
Associated Press