On Friday, the U.S. Food and Drug Administration (FDA) released a drug information update and a drug safety communication concerning recent dangers found in the drug Xeljanz, known generically as tofacitinib. The FDA tofacitinib warning discussed new dangers and how healthcare providers and consumers can safeguard against them.
Analyzing The FDA Tofacitinib Warning
The FDA tofacitinib warning alerted the nation to a development in a clinical safety trial that revealed that tofacitinib, in the form of Xeljanz and Xeljanz XR, increased the risk of blood clots in the lungs (pulmonary embolisms) and death when administered as 10 mg tablets taken twice daily.
Tofacitinib is a drug used to treat rheumatoid arthritis, which is an autoimmune disorder that presents with high levels of joint pain. Tofacitinib creates relief through reducing immune system activity and is used as an alternative to methotrexate and non-biologic disease-modifying antirheumatic drugs (DMARDs). Tofacitinib was approved for use in adults in 2012 and in 2017 it was also cleared to treat psoriatic arthritis under the same conditions as rheumatoid arthritis.
Following the FDA tofacitinib warning, the manufacturing company Pfizer has announced it will be transitioning patients from the 10 mg twice daily regime to the lower, currently approved, 5 mg twice daily regime. The clinical trial will continue despite the FDA tofacitinib warning and will likely conclude by the end of 2019.
The FDA tofacitinib warning stated that patients are not advised to cease or change their tofacitinib dosage without consulting a healthcare professional to prevent the worsening of symptoms. The FDA tofacitinib warning did, however, advise patients to seek immediate medical attention if they experience symptoms that suggest a blood clot in your lungs or other complications. Unusual side effects of tofacitinib include:
- Sudden shortness of breath
- Difficulty breathing
- Chest pain or
- Back pain
- Coughing up blood
- Excessive sweating
- Clammy or blue-tinged skin
The FDA tofacitinib warning also advised doctors and healthcare specialists to stop treatment with tofacitinib and conduct a patient evaluation if the patient presents with symptoms of thrombosis.
Additionally, the FDA has recommended that doctors reserve the use of tofacitinib to treat ulcerative colitis exclusively for patients who cannot tolerate tumor necrosis factor (TNF) blockers.
For more information about Xeljanz, tofacitinib, and how to pursue compensation for complications, visit Parker Waichman’s Xeljanz Thromboembolic Injury And Fatal Lung Clot Lawsuit Page.
How The FDA Tofacitinib Warning Affects Consumers
The FDA tofacitinib warning was the first step in measures to ensure patient safety. Unfortunately, with a reactive organization like the FDA, this warning comes from the suffering of victims across the nation who deserve to be compensated for their suffering. If you or a loved one have been victimized by side effects while using Xeljanz, Xeljanz XR, or generic-brand tofacitinib, contact Parker Waichman LLP to get the best legal representation working for you.
At Parker Waichman LLP, teams of experienced trial attorneys have collectively brought hundreds of defective drug cases on behalf of their clients. Parker Waichman’s attorneys are willing to pursue your case to its utmost conclusion in order to earn you the compensation that you deserve. Don’t wait, contact Parker Waichman today for a free consultation.