In this Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took new regulatory action regarding the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or … [Read more...]
Stelara-associated Cardiovascular Events: Emerging Drug Safety Issue
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...]
Lemtrada Side Effects Being Investigated By European Drug Regulatory Agency
The multiple sclerosis drug Lemtrada (alemtuzumab) is under scrutiny from the European Medicines Agency (EMA), according to the drug regulator’s April 12, 2019 press release, “Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing”. From this April 14, 2019 Medscape article, “PRAC Restricts Use of Alemtuzumab for MS … [Read more...]
Zelnorm: FDA Approval In 2019 (After 2007 Recall) Despite Continuing Cardiovascular Safety Concerns
In April 2019 we learned that the FDA is allowing Zelnorm back on the market 12 years after there was an FDA-mandated Zelnorm recall. From this April 3, 2019 Healio article, “FDA approves reintroduction of Zelnorm for IBS-C in certain women”, we get this significant point: Sloan Pharmaceuticals [(the responsible drug company)], a subsidiary of … [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...]
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...]
Will FDA Allow Zelnorm To Return After 2007 Recall For Safety Reasons?
We start with this drug safety question: Despite a possible benefit to some limited patient population, is allowing IBS drug Zelnorm back on the market really warranted in view of the potential cardiovascular safety signal, with suicidal ideation and behavior being another issue? For where things seemed to stand at the conclusion of an October … [Read more...]
Increased Risk of Heart Attack / Stroke in Users of Long-Acting Inhaled Bronchodilators
Types of Long-Acting Inhaled Bronchodilators Long-acting inhaled bronchodilators -- such as long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) -- are used to treat patients with chronic obstructive pulmonary disease (COPD). They function by expanding the airways and helping them stay expanded for a longer period of … [Read more...]
EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya
UPDATE: On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings. (12/27/17). Background After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be … [Read more...]