FDA Cautions Against Safety of Endo's Testosterone Injection, Risks of Aveed Outweigh the Benefits
The U.S. Food and Drug Administration is questioning the safety of an injectable hormonal product.
Reviewers recently referred to safety data on Endo Health Solution's Inc's twice-rejected testosterone injection Aveed as "concerning," showing that the therapy was associated with severe and immediate post-injection adverse events.
Endo is seeking approval for Aveed as replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone hormone.
At this time, no deaths have been reported from the post-injection reactions, but several resuscitations and hospitalizations were required, according to documents posted on the FDA's website.
"There are no known approaches to predict or prevent the occurrence of an Aveed-related severe post-injection reaction for any patient," an FDA reviewers said. "It is unclear whether a 'slowly administered' intramuscular injection or a 30 minute post-injection wait time in the health care provider's office will entirely mitigate this risk."
The FDA denied the approval of the drug in 2008 and again in 2009, citing that its risks outweighed the benefits.
Yet reviewers said as of Tuesday this week that the drug met the regulatory requirement for efficacy for a testosterone replacement indication.
Researchers have said that in order to combat negative effects, they are hoping to lower injections.
The most commonly reported adverse effects were acne, fatigue, cough, injection site pain, insomnia and sinusitis, among others.
The FDA's advisory panel will vote on the drug's safety profile and approval on Thursday.
Aveed, or testosterone undecanoate, is a long-acting formulation of testosterone in castor oil and benzyl benzoate, and is intended for intramuscular injection.