Zurampic Approved for Gout
December 22, 2015 – The U.S. Food and Drug Administration (FDA) approved Zurampic (lesinurad) for the treatment of hyperuricemia (high uric acid levels in the blood) associated with gout. Zurampic is manufactured by AstraZeneca.
Gout is a type of inflammatory arthritis that results when urate crystals collect in joints – causing redness and swelling in the affected joints. Zurampic is recommended to be used in combination with a xanthine oxidase inhibitor (XOI), such as allopurinol or febuxistat, which lowers the production of uric acid for patients who have not achieved the target serum uric acid levels with an XOI alone.
Labeling includes a boxed warning about the possibility of acute kidney failure when taking Zurampic. Therefore, AstraZeneca will conduct further studies to evaluate both kidney and cardiovascular risks with its use. Dosage forms are available in 200mg oral tablets, and will be launched during the first quarter of 2016.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.