U.S. Food and Drug Administration (FDA) staff expressed concern over safety data on Endo Health Solutions Inc.’s Aveed, a testosterone injection.
Aveed (testosterone undecanoate) has been rejected twice previously and FDA reviewers said they found the safety data “concerning” and noted that Aveed therapy was associated with severe and immediate post-injection events, said Reuters.
Aveed is a long-acting testosterone formulation in castor oil and benzyl benzoate. Intended for intramuscular injection, the most commonly reported side effects were acne, fatigue, cough, injection site pain, insomnia, and sinusitis, said Reuters.
Resuscitations and hospitalizations were needed in some cases; no deaths have been reported related to post-injection reactions, according to reviewers’ documents posted to the FDA’s website today. According to the reviewers, “There are no known approaches to predict or prevent the occurrence of an Aveed-related severe post-injection reaction for any patient…. It is unclear whether a ‘slowly administered’ intramuscular injection or a 30 minute post-injection wait time in the healthcare provider’s office will entirely mitigate this risk,” they wrote, said Reuters.
Endo seeks FDA approval for Aveed, which is meant to be a replacement therapy in men for conditions related with testosterone hormone deficiency or complete absence of the hormone, testosterone, explained Reuters. The federal regulator initially rejected the therapy in 2008 over safety concerns. The second rejection took place in 2009 over Aveed’s risks outweighing its benefits.
Federal reviewers did say that Aveed has met regulatory efficacy requirements for a testosterone replacement; however, the FDA said it found it concerning that Endo has failed to correctly categorize Endo’s use and expressed concern over the consistently high adverse event rate, said Reuters. The agency also said Endo’s “unwillingness to acknowledge or effectively address possible increased rates is concerning.”
The reviewers said that while a risk management strategy is being considered for Aveed, the greatest benefit would be administering less injections than other current treatment options, said Reuters. The panel is scheduled to vote on Aveed’s safety profile and approval later this week. Researchers say they hope to be able to lower injections and reduce negative side effects, said Science World
According to the FDA, the panel will discuss the efficacy and safety of the Aveed intramuscular injection with the safety discussion focusing on post-marketing reports of oil microembolism in the lungs and potential anaphylactic reactions.
Low testosterone levels can occur for a variety of reasons including, testicular injury, testicular cancer or testicular cancer treatment, hormonal disorders, infection, HIV/AIDS, Type 2 diabetes, obesity, or chronic liver or kidney disease, for example, according to WebMD. Men with low testosterone levels may be at increased risk for rheumatoid arthritis, according to a new study. Low testosterone scores often lead to drops in bone density, which means that bones become more fragile and vulnerable to breaks.