What are the details of your prescription?
Uloric
Generic Name: Febuxostat
Drug Category: Xanthine Oxidase Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.
| Approved Uses |
|
Indicated for the chronic management of hyperuricemia in patients with gout. There is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine. Gout flares may occur after initiation of ULORIC due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. In order to prevent gout flares when ULORIC is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended. In the randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC. There have been postmarketing reports of fatal and non-fatal hepatic failure in patients taking ULORIC, although the reports contain insufficient information necessary to establish the probable cause. ULORIC is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, Lesch-Nyhan syndrome). Postmarketing reports of serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) have been reported in patients taking ULORIC. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans. Animal studies: increased neonatal mortality and a reduction in the neonatal body weight gain. Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. Febuxostat is present in rat milk. |
| Off-label Uses |
|
• Use in patients under the age of 18. GoToSource • Dosage greater than 80 mg per day without renal impairment. GoToSource • Tumor lysis syndrome prophylaxis. GoToSource • Reduce acid-induced acute lung injury and acetaminophen liver injury. GoToSource |
| Adverse Events |
|
Myocardial infarction, stroke and increased thyroid-stimulating hormone values. GoToSource Liver failure and jaundice. GoToSource Anaphylaxis. GoToSource Rhabdomyolysis (breakdown of muscle tissue). GoToSource Cutaneous leukocytoclastic vasculitis. GoToSource Hypertension. GoToSource There is an increased risk of death with Uloric compared to another gout medicine, allopurinol. GoToSource Upper respiratory tract infections and kidney stones. GoToSource |
| Litigation |
|
Lawsuits filed for liver failure, rhabdomyolysis, anaphylactic reactions, stevens johnson syndrome, heart attacks, kidney damage, strokes and psychosis. |
The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.
