Xeljanz (tofacitinib) is a medication used to treat certain types of arthritis or ulcerative colitis. It was issued the serious Boxed Warning by the Food and Drug Administration in 2019.
On July 26, 2019, the FDA updated and approved a Boxed Warning for the Xeljanz because it puts patients at risk of blood clots in the lungs and death. This information was gathered after a postmarketing study that monitored how the 10mg dosage interacts with those taking it.
Xeljanz was developed by Pfizer and approved in 2012 to treat adults with rheumatoid arthritis. Additionally, it is used to treat active psoriatic arthritis and ulcerative colitis.
Rheumatoid arthritis is a condition that causes the body to attack its own joints. This causes pain, swelling, and a loss of function in the affected areas.
In 2017, Xeljanz was approved to treat psoriatic arthritis (another condition that causes joint pain and swelling) as an alternative to using methotrexate and similar medications.
Finally, in 2018, Xeljanz was approved to treat ulcerative colitis. That is a condition which causes a chronic, inflammatory disease that affects the colon.
Xeljanz helps to decrease the immune systems activity which is what causes arthritic problems. It was mainly developed as an alternative medication for those who didn’t respond well to other immune system suppressants. Xeljanz is currently prescribed in 5mg doses (including extended release, “XR”), but once increased to 10mg has some very controversial side effects.
Xeljanz Post-Marketing Study and Side Effects
The FDA required the postmarketing study to be conducted by Pfizer, and evaluated patients with ulcerative colitis for a risk of cardiovascular events, cancer, and infections. This was to make sure it was safe to use in elevated doses.
The Data Safety Monitoring Board initially identified the dangerous side effects of an increased dosage of Xeljanz, including death and pulmonary embolism (blood clot in the lungs).
Xeljanz is linked to an increase in blood clots and death when used at 10mg compared to patients taking it at 5mg doses.
The symptoms of a blood clot from Xeljanz may include:
If you or someone you love is experiencing any of these conditions, go to a doctor or emergency room immediately.
- Sudden shortness of breath
- Difficulty breathing
- Chest and back pain
- Coughing up blood,
- Excessive sweating
- Swelling of the legs or arms
- Leg pain or tenderness
- Unusually red or discolored skin that is painful to the touch
Other Xeljanz (tofacitinib) side effects include:
- Herpes zoster
- Urinary tract infection (UTI)
The FDA warns healthcare providers to avoid prescribing Xeljanz to patients with a history of thrombosis. Additionally, it indicates heavily limiting Xeljanz at 10mg to the shortest duration needed.
Filing a Xeljanz Lawsuit
If you or somebody you know has suffered from a blood clot, other serious side effects, or even death from taking Xeljanz, you should contact a lawyer that handles Xeljanz lawsuits.
Health complications from medications can severely affect your quality of life, take time away from work and family, and contribute to other major health episodes later in life. A lawyer skilled in handling a Xeljanz lawsuit will do everything they can to hold the manufacturer accountable.