Xeljanz Use for Rheumatoid Arthritis
Autoimmune disorders like rheumatoid arthritis may develop when the immune system begins to see the body’s own tissues as foreign material and begins to attack them. This may lead to inflammation, pain and destruction of joint and connective tissue, skin tissue, or gastrointestinal tract lining which may result in rheumatoid and psoriatic arthritis, ulcerative colitis and other conditions.
Xeljanz works to treat autoimmune disorders by blocking an enzyme which contributes to inflammation, known as Janus Kinase (JAK). Blocking of JAK enzyme can help to prevent or reduce the inflammation caused by overactive immune function.
Xeljanz Pulmonary Embolism Risk Study
In 2012, Xeljanz was approved for the treatment of RA at the dose of 5mg twice daily. In 2017, use for the treatment of psoriatic arthritis was approved at 5mg twice daily and in 2018, use for the treatment of ulcerative colitis was added at a dose of 5 or 10mg twice daily.
The 2012 approval included a mandate from the FDA requiring a post-marketing safety study which would examine side effects and dosing amounts. The medication had not been approved in the European Union over safety concerns and the FDA’s requirement for additional clinical data was intended to address similar concerns.
The post-marketing study examined adult patients with RA, over the age of 50 who had at least one cardiovascular risk factor such as high blood pressure and who were taking one of three possible regimens:
- Xeljanz 5mg twice daily
- Xeljanz 10mg twice daily
- Anti-TNF medication such as Humira or Remicade
Preliminary study results showed an increased risk of pulmonary embolism (PE) and deep vein thrombosis (DVT) associated with an increased risk of death in patients taking 10mg twice daily. These patients were switched to the lowe3r 5mg twice daily dose for safety reasons, but final results showed a continued increased risk of death.
In addition to the study results, the FDA had received a number of serious adverse event reports citing PE and DVT and including some deaths. This prompted the FDA to issue a February 2019 safety alert warning of the increased risk of PE, DVT and VTE-associated death in patients taking Xeljanz and required Pfizer to update Xeljanz prescribing information.
Pulmonary Embolism and Deep Vein Thrombosis
A venous thromboembolic event is a blood clot that develops in the veins such as pulmonary embolism or deep vein thrombosis.
Pulmonary embolism occurs when a blood clot forms or becomes lodged in the lungs. Symptoms of PE may include:
- Chest pain
- Irregular heartbeat
- Shortness of breath
- Dizziness or fainting
- Sweating or clammy skin
- Coughing up blood
Deep vein thrombosis occurs when a blood clot forms or becomes lodged in a deep vein, most often in the legs. Symptoms of DVT may include:
- Pain and tenderness in affected area
- Swelling in affected area
- Redness in affected area
Any symptoms of DVT or PE should be reported a health care professional right away. Sudden or severe symptoms may warrant emergency treatment.
Xeljanz Warnings and Side Effects
Though Xeljanz was approved for use in the U.S. in 2012, use in the EU was denied over concerns of risks including cancer, high blood pressure, liver damage, stomach bleeding and infection. The FDA requires a “black box warning” to be included on all prescribing information for Xeljanz or Xeljanz XR which warns of the risk of serious infections and malignancies or cancers that may occur with Xeljanz use.
All medications may cause side effects, most of which are mild to moderate and will go away with time. Others may be more severe or even serious and life-threatening.
Xeljanz common side effects may include:
- Upper respiratory infection
- Nasal or cold symptoms
- Increased blood pressure
Xeljanz severe side effects may include:
- Serious infections including bacterial, viral and fungal infections
- Lymphomas or other types of cancer
- Reactivation of Hepatitis or Herpes viral infection
- Gastrointestinal perforation
- Allergic or hypersensitivity reaction
- Venous thromboembolic event such as PE or DVT
Persistent or bothersome side effects should be reported to a health care professional. Serious side effects, symptoms of PE or DVT or sudden symptoms should be reported right away and may require emergency medical attention.
Xeljanz (tofacitinib) is approved to treat rheumatoid arthritis, ulcerative colitis and psoriatic arthritis but may increase the risk of venous thromboembolic event (VTE) or blood clot formation in the veins. The increased risk may include events such as pulmonary embolism (PE) in the lungs and deep vein thrombosis (DVT) in the legs or extremities, both of which may be serious or life-threatening.
The U.S. Food and Drug Administration (FDA) issued a February 2019 safety alert which warned of the increased risk of PE or DVT in patients who had taken Xeljanz 10mg twice daily. The study results that the warning alert was based on also indicated that some increase in risk was also seen in patients taking a lower dose of 5mg twice daily.
The FDA also required that Pfizer update Xeljanz and Xeljanz XR prescribing information to include the increased risk of VTE, DVT and PE but reports indicate that the drug has been responsible for hundreds of serious injuries and several deaths. Pfizer may be facing Xeljanz lawsuits for injuries and deaths caused by the medication.
Xeljanz Post Marketing Safety Results
After the 2012 approval of Xeljanz, its manufacturer Pfizer was required to conduct a post marketing safety study to examine further risks of Xeljanz. The study examined rheumatoid arthritis patients over the age of 50 with at least one cardiovascular risk factor such as arrhythmia or high blood pressure. The study compared patients taking Xeljanz 10mg twice daily, Xeljanz 5mg twice daily and a control group of patients taking TNF inhibitors such as Remicade or Humira.
Early results of the post marketing study showed that Xeljanz may increase the risk of blood clotting events known as venous thromboembolic (VTE) events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) which may be serious or life-threatening in the high dose arm of 10mg twice daily. Patients in this group were then switched to the lower dose for safety reasons but subsequent results also confirmed an increased risk of death in the 5mg twice daily group.
Based on study results, the FDA issued a February 2019 safety alert warning of increased risk of blood clots as pulmonary embolism or deep vein thrombosis. As of March 2019, at least 63 DVT serious events including 5 deaths and at least 109 PE serious events including 14 deaths had been reported to the FDA.
Xeljanz PE and DVT Effects
Xeljanz labeling did not initially include warnings about blood clot formation but prescribing information has been updated to warn of venous thromboembolic events (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE).
Symptoms of DVT may include:
- Pain in lower leg (or other affected area)
- Swelling in lower leg
- Warmth in affected area
- Redness or discoloration of skin in affected area
Symptoms of PE may include:
- Shortness of breath
- Chest or back pain
- Coughing with bloody discharge
- Clammy skin
- Pale, gray or bluish appearance
Venous thromboembolic events may sometimes occur without warning or symptoms but may lead to sudden death in severe cases. All symptoms should be reported to a health care provider immediately. Sudden or severe symptoms should be treated as a medical emergency.
Filing a Xeljanz Lawsuit
People or loved ones of those who took took Xeljanz for RA, PSA or UC and suffered injury or death may be filing lawsuits against Pfizer, manufacturer of Xeljanz and Xeljanz XR.
Injuries named in lawsuits may include:
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Death due to DVT or PE
People or loved ones of those who have been injured after taking Xeljanz should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.