this off-label use is not backed by the same level of controlled human trial evidence as the lipodystrophy indication Known risks and side effects: Injection site reactions, including erythema, pruritus, pain, and bruising at the injection site Arthralgia (joint pain) and peripheral edema (fluid retention), recognized class effects of GH-axis stimulation Increases in blood glucose and reduced insulin sensitivity, with clinical trials showing a higher rate of elevated HbA1c and new-onset hyperglycemia versus placebo Formation of anti-tesamorelin antibodies, reported in a substantial proportion of treated patients, with unclear long-term clinical significance Contraindicated in people with active malignancy, pituitary or hypothalamic disruption, or pregnancy, per FDA labeling Evidence snapshot: The strongest evidence is a set of Phase 3 human randomized controlled trials that supported FDA approval of tesamorelin for reducing visceral abdominal fat in HIV-associated lipodystrophy (approved 2010), plus a separate placebo-controlled human RCT (Baker et al., 2012, Archives of Neurology) showing improved executive function in older adults
Defendants originally had just five days to respond to the claims, but an extension was granted, and they now have until July 26th to respond
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It is also the endogenous ligand of the opioid growth factor that plays a vital role in the regulation of tissue growth and regeneration
