The FDA Has Slapped Xeljanz With a Boxed Warning.
Patients Have Increased Risk for Serious Blood Clots (And Even Death) After Using Xeljanz.
Patients (or their family members) who took Xeljanz or Xeljanz XR and later suffered from Deep Vein Thrombosis, Pulmonary Embolism or another blood clot problem may have serious legal options.
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FDA Issues Strongest Possible Warning to Xeljanz and Xeljanz XR
In July 2019, the FDA placed a Boxed Warning, the strongest warning the organization can issue, on Xeljanz and Xeljanz XR about increased risks for blood clots, sometimes so severe it can lead to death in patients.
The Boxed Warning comes after the FDA announced in February 2019 it was investigating a potential link between Xeljanz and increased blood clots after a clinical trial found there was an increased risk of blood clots in patients who took the higher (10 mg) dosage of the medication. At the time, the FDA issued a Safety Communication to patients about potential concerns with the medication.
Xeljanz and Xeljanz XR are commonly prescribed to treat Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis.
Blood Clots, Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
This Sounds Super Scary! Because it is.
Patients dealing with rheumatoid arthritis or ulcerative colitis already have enough health problems to worry about. They shouldn’t have to add other serious problems to their list like Deep Vein Thrombosis (DVT) (a serious blood clot in a deep vein often found in the legs) Pulmonary Embolism (PE) (a potentially life-threatening condition where a blood clot blocks arteries in the lungs), Stroke (severe damage to the brain as a result of lack of blood flow), other kinds of dangerous blood clots or even (and we hate to say this, but we have to) death. It’s just not right.
If you or a family member suffered from any of these conditions after using Xeljanz or Xeljanz XR, please contact us to talk about your potential legal options.
Other Countries Weren’t So Sure About Xeljanz From the Beginning
In 2013, the European Medicines Agency (EMA), similar to the U.S.’s FDA, declined to approve Xeljanz due to concerns about potential health risks. The Committee for Medicinal Products for Human Use (CHMP) recommended against approving the drug because they believed that the potential benefits did not outweigh the potential risks.
It wasn’t until March 2017 that the European Commission reversed this stance and approved the medication. However, the approval was only for use in patients with moderate-to-severe rheumatoid arthritis (not ulcerative colitis) and ONLY for the lower 5 mg per day dose.
Now, patients hurt by Xeljanz and Xeljanz XR are coming together to take action. If you or a family member were hurt, contact us to learn about your potential legal options.
From 2013 to 2018, the FDA received 52 reports of DVTs and 79 reports of PEs related to Xeljanz. Fifteen of the patients died.
–– FDA Adverse Events Reporting System (FAERS) Public Dashboard