Adverse Effects
In clinical trials conducted in adults, the most commonly reported adverse effects with raltegravir have included insomnia in 4% of patients, and headache, neutropenia, anemia, or thrombocytopenia in 1–2%. Other adverse effects included dizziness, fatigue, pruritus, nausea, and diarrhea. Less common adverse effects included anxiety, depression, asthenia, abdominal pain, and vomiting (all occurring in < 2% of patients). Elevated serum aminotransferases, bilirubin, glucose, and lipid values occurred in 1–6% of patients. Rates of discontinuation in clinical trials have been no different in the raltegravir and placebo groups. Post-marketing reports include rare cases of elevated creatine kinase, myopathy, and rhabdomyolysis, as well as nephrolithiasis, renal and liver failure, and hypersensitivity or severe dermatologic reactions.[2–5]
The manufacturer reports that the adverse effects documented in children participating in the IMPAACT P1066 trial were similar to those seen in adults.[3] One child experienced hyperactivity and insomnia and another experienced a serious allergic rash. One patient experienced elevated serum aminotransferases.
Pediatr Pharm. 2012;18(1) © 2012 Children's Medical Center, University of Virginia
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