Rinvoq is an arthritis drug that has a “Black Box” warning about the risk of cancer, blood clots, heart attacks, strokes and death.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Rinvoq induced injury cases in all 50 states. If you or a loved one had a heart attack, stroke, blood clots cancer or died after taking Rinvoq, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
AbbVie Updates Rinvoq Label With Safety Warnings
In December 2021, AbbVie issued a press release regarding an update to the Prescribing Information for Rinvoq with warnings about heart attacks, strokes, cancer, blood clots and death.
Those risks were recently identified in post-marketing studies for Xeljanz, a similar drug in 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 a prescription medicine manufactured by AbbVie. It was approved in August 2019 for the treatment of adults with moderate to severe rheumatoid arthritis (RA) when other treatments, such as methotrexate, did not work well.
What are JAK Inhibitors?
Rinvoq is a JAK (Janus kinase) inhibitor, which means it belongs to a group of drugs that block the activity of the immune system to reduce inflammation, pain, swelling and stiffness associated with arthritis.
Other JAK inhibitors include Xeljanz® (active ingredient: tofacitinib) and Olumiant® (active ingredient: baricitinib).
What is the Problem?
A recent safety study of Xeljanz, the most popular JAK inhibitor, found a significantly higher risk of many severe, life-threatening side effects compared to another anti-inflammatory drug called a TNF blocker.
FDA Requires “Black Box” Warnings for Rinvoq
In September 2021, the FDA ordered AbbVie to put a “Black Box” warning on Rinvoq about a risk of heart attacks, strokes, cancer, blood clots and death.
Rinvoq and Cancer
Rinvoq may increase a user’s risk of all types of cancer, except non-melanoma skin cancer. In safety studies, JAK inhibitors were linked to especially high rates of lymphomas and lung cancer among current and former smokers.
Rinvoq and Blood Clots
Rinvoq may increase a user’s risk of blood clots, which can lead to life-threatening complications. These blood clots can develop in the legs, in a condition known as Deep Vein Thrombosis (DVT). Blood clots can also travel to the lungs and cause a Pulmonary Embolism.
Rinvoq and Heart-Related Events
Rinvoq is linked to many severe, life-threatening heart-related events, including:
- Cardiac arrest
- Heart attack
- Ischemic stroke
- Acute coronary syndrome
- Atrial fibrillation
- Heart failure
Safety Study Links JAK Inhibitors With Serious Risks
Rinvoq is a JAK inhibitor, which means it is in the same class of drugs as Xeljanz. When the FDA approved Xeljanz in 2012, Pfizer was required to study the risks of Xeljanz vs. another class of arthritis medicine, called a Tumor Necrosis Factor (TNF) blocker.
Unfortunately, the safety study found that patients on Xeljanz had significantly higher rates of blood clots, cancer, heart-related events (heart attacks and strokes), and death.
In September 2021, the FDA ordered Pfizer to update the label on Xeljanz about these risks. AbbVie was also required to add warnings to the label on Rinvoq: “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
In February 2019, the FDA issued a Safety Warning after the higher dose of Xeljanz (10-mg twice daily) was linked to an increased risk of blood clots in the lungs (pulmonary embolism) and death.
In February 2021, the FDA issued another warning after the lower doses of Xeljanz (5-mg twice daily) were also linked to higher rates of cancer and serious heart-related problems, such as strokes and heart attacks.
In September 2021, the FDA ordered the manufacturers of JAK inhibitors, including Rinvoq, to add a “Black Box” warning regarding the increased risk of cancer, blood clots, heart-related events, and death.
Do I have a Rinvoq Lawsuit?
The Schmidt Firm, PLLC is currently accepting Rinvoq induced injury cases in all 50 states. If you or a loved one had a heart attack, stroke, blood clots cancer or died after taking Rinvoq, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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