Federal regulators warn that the side effects of Uloric, a gout medication, could increase the risk of heart-related deaths.
The FDA issued a drug safety communication on November 15 announcing that it was opening an investigation into deaths linked to Uloric. The decision comes following a clinical trial which showed an increase in the risk of fatal cardiovascular events when compared to a competing gout medication, allopurinol.
Uloric (febuxostat) is a Takeda Pharmaceuticals medication approved for the treatment of gout by the FDA in 2009. It already carries a warning of an increased risk of heart attacks, strokes and cardiovascular death, which were seen in its initial clinical trials.
Those findings led the FDA to require additional post-marketing safety research, and the results of that research appears to have the agency concerned.
The follow-up safety trial involved more than 6,000 patients with gout who were treated with either Uloric or allopurinol, which is sold under the brand names Zyloprim and Aloprim. The findings suggested that Uloric raised the risk of both heart-related deaths and deaths from all causes.
“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA advises. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”
Concerns about Uloric were also raised in a whistleblower lawsuit filed in 2012 by Helen Ge, a former safety consultant with Takeda Pharmaceuticals. In her lawsuit, Ge alleged that Takeda defrauded Medicare and Medicaid by failing to report that Uloric could cause dangerous side effects when used in combination with other drugs, such as digoxin, imuran, methadone, and warfarin. Some of those interactions have been fatal, she warned.
The interactions Ge reported included bone marrow failure, severe bleeding and kidney failure. She claimed that Takeda altered and falsified adverse event reports sent to the FDA to make Uloric side effects appear less severe.
Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.
The FDA is calling for any doctors or patients who experience adverse events linked to Uloric to file a report with the agency’s MedWatch adverse event reporting program. The safety communication indicates that the FDA will update the public when it has additional, relevant information regarding Uloric risks.