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Table Of Contents
What is Rinvoq?
Rinvoq is a JAK (Janus kinase) inhibitor approved for adults with moderate to severe rheumatoid arthritis for whom methotrexate did not work well. The medicine was approved by the U.S. Food and Drug Administration (FDA) in August 2019.
FDA Warning: Rinvoq Linked to Heart Attack, Cancer, Blood Clots, Death
The FDA is requiring revisions to the Boxed Warning (1.) on Rinvoq and 2 other similar Janus Kinase (JAK) inhibitor drugs, Xeljanz/Xeljanz XR (tofacitinib) and Olumiant (baricitinib), to include information about the risks of serious heart-related events, cancer, blood clots, and death.
“The FDA is requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant and Rinvoq,” FDA said. “Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.”
Rinvoq Side Effects
Serious side effects of Rinvoq may include:
- Heart-related events
- Heart attack
- Stroke
- Cancer
- Blood clots
- Lymphoma
- Lung cancer
- Death
More moderate side effects of Rinvoq may include:
- Upper respiratory tract infections (such as a cold or sinus infection)
- Nausea
- Cold sores
- Shingles
EMA Confirms Measures to Minimize Risk of Side Effects with Rinvoq
On Jan. 23, 2023, the European Medicines Agency (EMA) endorsed measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimize the risk of serious side effects with Rinvoq and other JAK inhibitors used to treat several chronic inflammatory disorders.
The committee recommended that JAK inhibitors only be used in the following patients if no suitable treatment alternatives are available:
- Those aged 65 years or above
- Those at increased risk of major cardiovascular problems (such as heart attack or stroke)
- Those who smoke or have done so for a long time in the past, and
- Those at increased risk of cancer.
Additionally, JAK inhibitors should be used with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism, VTE) other than those listed above. The dosage should be reduced in patient groups who are at risk of VTE, cancer, or major cardiovascular problems, whenever possible.
If You Are Taking Rinvoq
Patients taking Rinvoq should tell their healthcare provider if they are a current or past smokers, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put them at higher risk for serious problems with the drug. Anyone with symptoms of a heart attack, stroke, or blood clot should dial 9-1-1 immediately.
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The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Rinvoq lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
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