On September 1, 2021, we saw new FDA Xeljanz warnings about the increased risks of heart attacks, strokes, cancer, blood clots, and deaths. These Xeljanz drug safety problems have been associated with all doses of Xeljanz (5 mg tablet and 10 mg tablet) and Xeljanz XR (11 mg tablet and 22 mg tablet). This September 2021 document, “FDA requires … [Read more...]
Tasigna Drug Injury Lawsuits Federal Court MDL Consolidation Order
There is a newly created Tasigna multi-district litigation (MDL) for those Tasigna drug injury lawsuits filed in the federal court system. We get some of the reasoning for this consolidation of Tasigna side effects cases from the August 10, 2021, JPML Transfer Order issued for IN RE: TASIGNA (NILOTINIB) PRODUCTS LIABILITY LITIGATION, MDL No. … [Read more...]
FDA Advisory Committee Meeting Could Review Risk/Benefit Profiles for All JAK Inhibitors
The FDA has delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal. From this June 25, … [Read more...]
Tasigna Lawsuits Update: New Jersey MCL and Federal Court MDL Consolidations
We are currently investigating Tasigna side effects cases as possible Tasigna drug injury lawsuits against Novartis for patients who have developed some serious medical conditions during their use of Tasigna. In early June 2021, the New Jersey Supreme Court consolidated Tasigna drug injury lawsuits filed against Novartis Pharmaceuticals Corp. … [Read more...]
Lemtrada Safety Issues Lead To Use Restrictions In Europe
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...]