Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada. This November 5, 2019 Multiple Sclerosis News Today report, “EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals … [Read more...]
Lemtrada Drug Safety Update: Use Restrictions And Patient Monitoring For Side Effects
On May 17, 2019 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Lemtrada Drug Safety Update, “Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements”, we get this summary: While an urgent [European Union (EU)] safety … [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...]
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...]
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...]
J&J Tries to Expand Invokana Label to Include Cardiovascular Benefits
Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs. If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]
Pradaxa And Xarelto May Double The Risk Of Heart Attacks Some Patients
In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart … [Read more...]
Farxiga / Jardiance / Invokana: Label Change Adds Ketoacidosis Warning
In August 2016 the FDA sent letters to Janssen Pharmaceuticals and AstraZeneca Pharmaceuticals for label changes about fatal cases of ketoacidosis cases involving Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), and Xigduo XR (dapagliflozin and metformin extended-release). As for the other diabetes … [Read more...]