The US FDA created an alert about the use of Febuxostat in Nov 2017. Febuxostat was approved in 2009 for treating gouty arthritis in adults but required the manufacturer to conduct a safety study as the drug label already carries a warning and precaution related to cardiovascular deaths.
The clinical trial was conducted in 6000 patients with gout treated with febuxostat compared to allopurinol. Febuxostat showed an increased risk of heart attacks, stroke, and heart-related deaths.
Healthcare professionals should always consider this FDA alert for safety reasons whether febuxostat needed to be prescribed. It is also advised that patients also should discuss with the physician or pharmacist in case they have any queries about the safety of febuxostat.
FDA is evaluating the safety of Febuxostat on a continuous basis and will update the public with necessary information. However, healthcare professionals and patients are requested to report for any side effects of febuxostat to the FDA MedWatch program.
This medication is a xanthine oxidase (XO) inhibitor, prescribed for gout and hyperuricemia (high level of uric acid in blood). It decreases the amount of uric acid in blood.
Contraindicated in patients treated with azathioprine, mercaptopurine or theophylline.
PO- The recommended dose is 40 to 80mg, once daily.
It comes as a tablet to take by mouth with or without food.
• Caution should be exercised in patients with history of liver, kidney diseases, chest pain, cancer, stroke, elderly, children, pregnancy, and breastfeeding.
• Caution should be exercised in patients who have undergone organ transplantation (kidney, liver, heart and lung).
• If condition worsens, stop the medication immediately.
• Most Common:
Swelling in the face, lips, tongue or throat regions, sweating, general illness and loss of appetite.
• Skin: Allergic reactions.
• Respiratory : Difficulty in breathing.
• Heart: Chest pain and heaviness in the chest region.
• Gastrointestinal : Nausea and stomach pain.
• Central Nervous System: Headache and confusion.
• Eye: Vision problems.
• Genitourinary: Dark colored urine.
• Less Common: Anemia, pain, swelling in the joint regions, stroke and inflammation of liver.
• Liver: ♦ Liver failure and jaundice.
Patient may develop with severe blood clot events; if so contact your healthcare provider immediately.
Store it at room temperature.
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