Posted from: Monday, February 01, 2016 - 01:52 PM - Present

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. 

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Friday, May 19, 2017 - 11:39 PM.