35 results

• Speculation Mounts for Potential FDA Panel Review of Health Risks from Xeljanz, Other JAK Inhibitors

  April 14, 2021

  Irvin Jackson

  Some believe the FDA is preparing to review the risks and benefits of Xeljanz and similar drugs given recent cancer and heart concerns.

• Investigation of Xeljanz Cancer and Heart Risks Launched in Canada

  April 8, 2021

  Irvin Jackson

  Growing concerns have led to Health Canada announcing a Xeljanz safety review, to determine whether more warnings or actions are needed following studies suggesting the ulcerative colitis drug could increase the risk of cancer and heart attacks.

• Xeljanz Cancer Warnings Leave More Questions Than Answers

  March 24, 2021

  Irvin Jackson

  New Xeljanz research links the drug to cancer risks, but has not yet led to a warning for users as to which types of cancer they may face.

• Xeljanz Heart and Cancer Concerns May Be Impacting FDA Review of Rinvoq for Psoriatic Arthritis

  March 19, 2021

  Irvin Jackson

  The FDA may be delaying approval for the drug Rinvoq to be used as a psoriatic arthritis drug due to its close ties to Xeljanz, which has been linked to heart risk and cancer concerns.

• Pfizer Files Lawsuit Over Xeljanz Generic Application

  March 5, 2021

  Austin Kirk

  Pfizer filed a patent lawsuit over an alleged attempt to create a generic version of Xeljanz shortly after the FDA announced new concerns about the drug's safety.

• Xeljanz Problems Highlighted in Study Data May Lead to New FDA Restrictions: Report

  February 8, 2021

  Irvin Jackson

  The FDA is weighing new restrictions on Xeljanz, following clinical trial data linking the drug to an increased risk of heart problems and cancer, according to a new report.

• Xeljanz Side Effects May Increase Risk of Cancer, Serious Heart Problems: FDA Alert

  February 5, 2021

  Russell Maas

  A new FDA warning indicates Xeljanz side effects may increase the risk of heart problems, including heart attacks, and cancer in patients over 50.

• FDA Approves High-Dose, Extended-Release Version of Xeljanz, Despite Blood Clot Risks

  December 20, 2019

  Irvin Jackson

  The FDA has approved higher dose formulations of extended release Xeljanz, despite concerns over the risk of potentially fatal blood clots.

• Blood Clot Problems from Xeljanz Draw Updated EMA Warning for High Risk Patients

  November 5, 2019

  Irvin Jackson

  European regulators warn that Xeljanz should not be given to any patients at high risk of blood clots unless absolutely necessary.

• Xeljanz Black Box Warning Added by FDA, Due to Risk of Blood Clots and Death

  July 26, 2019

  Irvin Jackson

  The FDA is warning that Pfizer's ulcerative colitis drug, Xeljanz, could cause pulmonary embolism and deep vein thrombosis at higher doses.