Despite indications that a gout pill is associated with an increased risk of heart attack and death, the Food and Drug Administration is allowing the medicine to remain on the market, but will require the label to carry a so-called Black Box, the most serious warning about the risk of a medication.
In explaining its decision, the agency maintained that the drug, called Urolic, may benefit some of the roughly 8.3 million Americans who suffer from this form of arthritis. Gout occurs when too much uric acid crystallizes and forms deposits in the joints, causing acute episodes of extreme pain.
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Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, wrote that Uloric “remains the only alternative to allopurinol,” noting that some patients suffer serious skin reactions and liver damage from allopurinol.
Only alternative? What about colchicine?