According to a recent FDA safety communication, Rheumatoid arthritis patients taking the 10 mg twice-daily dose of Xeljanz or Xeljanz XR may be at an increased risk for blood clots in the lungs (pulmonary embolism) and death.
The FDA issued this warning following the release of data from a clinical study of the drug showing an increased risk. The FDA warns patients to be aware of this risk and to watch for signs of pulmonary embolism (PE), which may include:
- shortness of breath,
- difficulty breathing,
- chest pain,
- coughing up blood,
- excessive sweating, and
- clammy or bluish-colored skin.
On February 25, 2019, the FDA released a safety communication notifying the public of an increased risk of blood clots in the lungs and death in RA patients taking the 10 mg twice-daily dose of Xeljanz or Xeljanz XR. At the time of this writing, the FDA had not approved the 10mg twice-daily dose for RA-only for ulcerative colitis.
The FDA based this action on the results of the ongoing clinical trial they required Pfizer to conduct when they originally approved the drug in 2012.
Though the trial is not yet complete, the most recent analysis of the data showed an increased occurrence of blood clots in the lungs and death in patients treated with 10 mg twice daily compared to patients treated with 5mg twice daily, or with the alternative medication.
Because of these results, the FDA advised patients to talk to their doctors about their dosages and to watch for signs of pulmonary embolism (PE). They also encouraged healthcare professionals to follow the prescribing information for the specific condition they are treating and to monitor patients for signs of blood clots and pulmonary embolism.
Patients who take Xeljanz may be at increased risk for:
- Blood clots
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
If you or a loved one has taken Xeljanz and suffered any of the above injuries, call PWS immediately for a free consultation at 954-462-6700.
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