The arthritis medication Olumiant has been linked to an increased risk of cancer, blood clots, heart attack, stroke, and death.
Need a Texas Olumiant 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 Olumiant, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is Olumiant?
Olumiant® (active ingredient: baricitinib) is a prescription medication for arthritis that is manufactured by Eli Lilly & Co. It was approved by the FDA in June 2018 for the treatment of adults with moderate-to-severely active rheumatoid arthritis, after other treatments failed.
How Does Olumiant Work?
Rheumatoid arthritis occurs when an overactive immune system attacks the joints, resulting in inflammation, pain, and swelling.
Olumiant works by decreasing the activity of the immune system. It belongs to a class of anti-inflammatory drugs called Janus kinase inhibitors (JAK inhibitors), which also includes Xeljanz® (active ingredient: tofacitinib) and Rinvoq® (active ingredient: upadacitinib).
What is the Problem?
In September 2021, the FDA added a “Black Box” safety warning for Olumiant and other JAK inhibitors about the increased risk of cancer, blood clots, heart-related events (strokes and heart attacks), and death.
Olumiant and Cancer
JAK inhibitors are linked to an increased risk of all types of cancer, with the exception of non-melanoma skin cancer. Studies found particularly high rates of lymphomas and lung cancer among people who were current or former smokers.
Olumiant and Serious Heart-Related Events
JAK inhibitors are also associated with a variety of serious cardiac events, including:
- Heart attack
- Ischemic stroke
- Acute coronary syndrome
- Atrial fibrillation
- Cardiac arrest
- Heart failure
Olumiant and Blood Clots
Patients on JAK inhibitors can develop blood clots, which can lead to life-threatening complications. Blood clots in the legs are also known as Deep Vein Thrombosis (DVT) or Arterial Thrombosis. These blood clots can travel to the lungs and cause a Pulmonary Embolism.
Olumiant is a JAK inhibitor, which means it works in the same way as Xeljanz. After a major safety study linked Xeljanz with a higher risk of cancer, blood clots, heart-related events, and death, the FDA ordered Eli Lilly & Co. to add similar warnings to the label on Olumiant:
“Since [Olumiant] 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 Safety Warnings for JAK Inhibitors
When the FDA approved Xeljanz for arthritis in November 2012, Pfizer was required to complete a safety study comparing the side effects of Xeljanz vs. another type of arthritis drug called a Tumor Necrosis Factor (TNF) blocker.
The study investigated two doses of Xeljanz — 10-mg twice daily and 5-mg twice daily — in roughly 3,800 patients with arthritis.
In February 2019, the FDA issued its first Safety Warning after the study found a higher risk of blood clots in the lungs (pulmonary embolism) and death in Xeljanz patients on the higher dose (10-mg twice daily).
In February 2021, the FDA issued another warning after the lower dose of Xeljanz was also linked to cancer and serious heart-related adverse events.
In September 2021, the FDA required a “Black Box” warning label for Xeljanz, Olumiant, and Rinvoq about the increased risk of serious heart-related events (stroke and heart attack), cancer, blood clots, and death.
Need an Olumiant Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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