According to a recent medical journal article, acute renal failure (ARF), or kidney failure, is reported as an adverse drug reaction 5.7 times more frequently with Uloric (febuxostat) than with other urate-lowering therapy (ULT) gout drugs, and 3.3 times more often with allopurinol. This is some important new Uloric drug safety information from our … [Read more...]
Uloric Increased Risk of Patient Cardiovascular Deaths, Says Health Canada
Based on the results of the CARES study, Health Canada mandated an Uloric label change in early November 2019 which warns about an increased risk of Uloric-related cardiovascular deaths. Uloric is now only approved for use in Canada as a treatment “to lower serum uric acid levels in patients with gout who have an inadequate response or intolerance … [Read more...]
Uloric Warning: Avoid Uloric If Prior Myocardial Infarction, Stroke, Or Unstable Angina
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a Uloric warning in July 2019 stating that patients with prior myocardial infarction, stroke, or unstable angina should avoid Uloric as there is a higher risk of death. From this July 2019 MHRA Drug Safety Update, “Febuxostat (Adenuric): increased risk of … [Read more...]
Uloric Lawsuits Follow Recent FDA Warnings About Heart-Related Deaths And Side Effects
Following recent FDA-mandated label changes, there have been Uloric lawsuits filed against Takeda Pharmaceuticals America, Inc., the manufacturer of Uloric. Uloric (febuxostat) tablets have been generally prescribed for the management of chronic gout since 2009. In February 2019 the FDA required its strongest safety warning, i.e., Bolded … [Read more...]
February 2019: Uloric “Black-Box Warning” For Heart-Related Deaths, Cardiovascular Side Effects
The FDA has required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, be included on a new Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric. From this February 2019 FDA Drug Safety Communication, "FDA adds Boxed Warning for increased risk of death with gout … [Read more...]
Uloric Recall Discussed By FDA Advisory Committees In January 2019
On January 10, 2019 the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee panelists discussed the potential biological mechanisms behind cardiovascular (CV) events associated with Uloric (febuxostat) use. From this January 11, 2019 MedPage Today report, “Make Uloric Second-Line for Gout, FDA Advisors Say”, … [Read more...]
Will FDA Order Uloric Recall Requested In June 2018 By Public Citizen
The consumer advocacy group Public Citizen asserts that a FDA Uloric recall is necessary following results of a large postmarketing study that showed higher rates of fatal cardiovascular (CV) events and all-cause mortality in patients taking the drug. More exactly, it is the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout … [Read more...]
November 2017 FDA Alert: Uloric May Increase Heart-Related Deaths Risk
On November 15, 2017 there was an email sent by the FDA about this MedWatch Safety Alert, “Febuxostat (Brand Name Uloric): Drug Safety Communication – FDA to Evaluate Increased Risk of Heart-related Death”, from which we get this excerpt: ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk … [Read more...]