There is a new drug safety issue for Stelara. This time it is that Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara. The Stelara French study results were outlined in this medical journal article, "Association Between Early Severe … [Read more...]
Possible Public Health Issue For Hemlibra Used By Hemophilia A Patients
Hemlibra (emicizumab) is used to prevent or reduce the frequency of bleeding episodes in hemophilia A patients. Hemlibra was initially approved by the FDA in 2017. In November 2019, however, some drug safety issues involving Hemlibra were pointed out. From this letter-to-the-editor piece, “Deaths Associated with Emicizumab in Patients with … [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...]
Imbruvica Cardiovascular Adverse Drug Reactions Soon After Administration
A medical journal article published by the Journal of the American College of Cardiology in October 2018 reports that Imbruvica cardiovascular adverse drug reactions often occurred soon after the administration of Imbruvica. In summary, patients treated with Imbruvica had an increased occurrence of severe and sometimes fatal cardiac events, with … [Read more...]
Xeljanz FDA Drug Safety Communication About Increased Risks of Blood Clots And Death
This Xeljanz FDA Drug Safety Communication was issued July 26, 2019: “FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)”. From that document we get the following information: The U.S. Food and Drug Administration has approved new … [Read more...]
Xeljanz Safety Concerns and New Precautions
You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death. In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing … [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...]
Xeljanz Used For Ulcerative Colitis May Increase Risk Of Pulmonary Embolism
There appears to be a new Xeljanz drug-safety problem for patients with ulcerative colitis (UC) who use the 10 mg twice daily recommended dosage of Xeljanz. In a February 20, 2019 Endpoints News article written by John Carroll, “Pfizer drops 10 mg dose of best-selling Xeljanz as study spotlights cardio safety issue, higher rate of deaths”: One … [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...]