Food and Drug Administration (FDA) directly. You are encouraged to report adverse events related to Pfizer products by calling 1-80 (U.S. Patients should always ask their doctors for medical advice about adverse events. Patients should tell their healthcare provider if they have had blood clots in the veins of their legs, arms, or lungs or clots in arteries in the past. The updated Boxed Warning regarding blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) discusses that blood clots have happened more often in patients who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking recommended doses of XELJANZ.
weakness in one part or on one side of your body. shortness of breath with or without chest discomfort. pain or discomfort in your arms, back, neck, jaw, or stomach. severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw. discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back. Patients taking XELJANZ should seek medical attention right away or get emergency help if you have any symptoms of a heart attack or stroke, including: The new Boxed Warning includes information regarding increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking recommended doses of XELJANZ, especially if you are a current or past smoker. Tell your healthcare provider if you are a current or past smoker or have had any type of cancer. The updated Boxed Warning regarding cancer discusses a higher risk of certain cancers, including lymphoma and lung cancer in patients taking XELJANZ, especially if you are a current or past smoker. The updated Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor taking recommended doses of XELJANZ. Specific risks associated with certain dosing are noted.Īs a result of this review, an additional warning for Major Cardiovascular Events, and updated warnings for Mortality, Cancer, and Blood Clots were included in the Boxed Warning and related Warnings and Precautions section of the prescribing information and in the Most Important Information I Should Know section of the patient Medication Guide for XELJANZ. 
The safety information below applies to all marketed formulations of XELJANZ.
Your healthcare provider should consider the benefits and risks of XELJANZ. Talk to your healthcare provider if you have any questions or concerns about this safety update.
FDA’s completed review of the ORAL Surveillance trial, a post-marketing required safety study.
XEL 2 USED FULL
full prescribing information for XELJANZ ® (tofacitinib) has been updated based on the U.S. Pfizer issued a media statement announcing that the U.S. Food and Drug Administration (FDA) updated the XELJANZ full prescribing information.
0 kommentar(er)
