Reading Time: < 1 minute (Reuters) - Reviewers for the U.S. Food and Drug Administration said safety data on Endo Health Solutions Inc's twice-rejected testosterone injection Aveed was "concerning" and showed that the therapy was associated with severe and immediate post-injection adverse events. No deaths were reported from the post-injection reactions, but resuscitations and hospitalizations were required in some cases, the reviewers said in documents posted on the FDA's website on Tuesday. (http://link.reuters.com/dem47t) "There are no known approaches to predict or prevent the occurrence of an Aveed-related severe post-injection reaction for any patient," the FDA reviewers said. "It is unclear whether a 'slowly administered' intramuscular … Read more
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