Rinvoq is an arthritis medication that carries a “Black Box” warning about the risk of cancer, blood clots, heart attacks, strokes, and death.
Need a Texas Rinvoq Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect of Rinvoq, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: AbbVie Updates Rinvoq Label With Safety Warnings
In December 2021, AbbVie announced that it will update the Prescribing Information and Medication Guide for Rinvoq to include stronger warnings about the risk of heart attacks, strokes, cancer, blood clots and death.
Those life-threatening side effects were identified in post-marketing studies that were recently conducted for Xeljanz, a similar drug to Rinvoq that also belongs to the JAK inhibitor class.
“Based on this class-wide update, the U.S. label for RINVOQ will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections.”
What is Rinvoq?
Rinvoq® (active ingredient: upadacitinib) is an arthritis medication that is manufactured by AbbVie. The FDA approved Rinvoq in August 2019 for adults with moderate-to-severe rheumatoid arthritis, but only after treatment with TNF blockers (such as methotrexate) did not work well.
How Does Rinvoq Work?
Rinvoq treats rheumatoid arthritis by reducing inflammation in the body. It is an immunosuppressant drug, which means that it prevents inflammation by decreasing the activity of an overactive immune system.
Rinvoq belongs to a class of medications called Janus Kinase Inhibitors (JAK inhibitors), which also includes Xeljanz® (active ingredient: tofacitinib) and Olumiant® (active ingredient: baricitinib).
What is the Problem?
In September 2021, the FDA issued a Safety Announcement for Rinvoq and required a “Black Box” warning label about the increased risk of cancer, blood clots, heart-related events (strokes and heart attacks), and death, compared to arthritis drugs in the TNF blocker class.
Rinvoq and Cancer
Rinvoq is associated with an increased risk of all types of cancer (except non-melanoma skin cancer). The label carries specific warnings for current and former smokers, after studies of Xeljanz found particularly high rates of lung cancers and lymphomas.
Rinvoq and Serious Heart-Related Events
Patients on Rinvoq may develop serious heart-related events, such as:
- Heart attack
- Ischemic stroke
- Acute coronary syndrome
- Atrial fibrillation
- Cardiac arrest
- Heart failure
Rinvoq and Blood Clots
JAK inhibitors are linked to higher rates of life-threatening blood clots, including blood clots in the legs (also known as Deep Vein Thrombosis or DVT) and Arterial Thrombosis. When these blood clots break loose and travel to the lungs, it is known as a Pulmonary Embolism.
The FDA ordered drug-makers to add “Black Box” warning label to the label on Rinvoq after another JAK inhibitor, Xeljanz, was linked to higher rates of blood clots, cancer, heart-related events, and death.
“Since [Rinvoq] share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.”
Timeline of FDA Warnings for Rinvoq and JAK Inhibitors
When Xeljanz was approved in November 2012, the FDA ordered Pfizer to study the safety of Xeljanz vs. arthritis drugs in the Tumor Necrosis Factor (TNF) blocker class.
Unfortunately, the study found that patients on Xeljanz (both 10-mg twice daily and 5-mg twice daily) were more likely to develop severe side effects compared to patietns on TNF blockers.
The first FDA Black Box Safety Warning for Xeljanz was issued in February 2019, after the study found that the higher dose of Xeljanz (10-mg twice daily) was linked to higher rates of blood lots and death.
The next FDA warning was issued in February 2021, after the lower dose of Xeljanz (5-mg twice daily) was also linked to cancer and serious heart-related adverse events, such as heart attacks and strokes.
In September 2021, the FDA required a stronger “Black Box” warning for Xeljanz, Rinvoq, and Olumiant after confirming that JAK inhibitors were linked to an increased risk of serious heart-related events (stroke and heart attack), cancer, blood clots, and death compared to TNF blockers.
Need a Rinvoq Lawyer in Texas?
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