What is Xeljanz?
Xeljanz is a prescription drug used to treat adults with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz, also known as tofacitinib, was originally approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to methotrexate. In 2017, the drug received approval to treat adults with psoriatic arthritis, and in 2018, the FDA approved it to treat ulcerative colitis, a type of chronic, inflammatory disease affecting the colon.
Xeljanz is Janus kinase (JAK) inhibitor, a type of inflammatory medication that works by calming the activity of the immune system by blocking proteins responsible for cell communication that may affect the body’s response to inflammation processes. Although Xeljanz and other JAK inhibitors are typically effective at treating patients with RA and other inflammatory ailments, the FDA has issued multiple warnings about the drug’s possible link to serious medical conditions.
Xeljanz and Cardiovascular Risks
When Xeljanz was first approved by the FDA in 2012, the agency required Pfizer, the drug’s manufacturer, to conduct safety clinical trials “to evaluate the risk of serious heart-related events, cancer, and infections.”
As part of their efforts, Pfizer conducted a trial specifically designed to assess the risk of cardiovascular events and malignancies which compared two doses of Xeljanz (5 mg twice daily, which is the approved dosage for RA, and a higher 10 mg twice daily dosage) with a tumor necrosis factor (TNF) inhibitor, another type of medication used to treat rheumatoid arthritis.
In order to evaluate Xeljanz’ safety at two higher doses, subjects enrolled in the study were required to be 50 years of age or older and have at least one additional cardiovascular risk factor.
According to the FDA, initial results of the now completed clinical trial show a “higher occurrence of serious heart-related events and cancer” in patients treated with both doses of Xeljanz than those patients treated with a TNF inhibitor.
Other Xeljanz Warnings
In February 2019, the FDA issued a safety communication, warning the public that “interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage.” In July 2019, the agency updated that communication and required Pfizer to place a boxed warning on Xeljanz prescription information.
While the FDA has not approved the higher dosage for patients with RA, the dosing regimen of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis who are unable to take other medications.
Symptoms of a blood clot in the lungs can be serious, and the FDA has warned that patients taking Xeljanz should seek medical attention immediately if they experience:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
Patients taking the higher dosage to treat RA were more at risk of blood clots; however, those risks could also apply to those taking Xeljanz to treat ulcerative colitis.
Other Xeljanz Risks
Common side effects linked to Xeljanz may include:
- upper respiratory tract infections (common cold, sinus infections)
- nasal congestion
- sore throat
- runny nose (nasopharyngitis)
Serious side effects of Xeljanz may include serious infections, cancer and immune system problems, tears (perforation) in the stomach or intestines, and changes in certain laboratory test results.
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How Can an Attorney Can Help?
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
If you have been injured by Xeljanz, you may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
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For more information, contact Attorney Group. When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have.
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