Keytruda Granted Full Approval for Urothelial Carcinoma Indication
August 31, 2021FDA Approves New Long-Acting Schizophrenia Treatment
September 1, 2021September 1, 2021 – The U.S. FDA is requiring new and updated warnings on a class of drugs called JAK inhibitors due to an increased risk of cancer, blood clots, serious heart-related events (such as heart attack or stroke), and death. This decision applies only to JAK inhibitors that are used to treat chronic inflammatory conditions, such as rheumatoid arthritis (RA).
- This requirement results from the FDA's analysis of safety trial data that compared the JAK inhibitor Xeljanz® (tofacitinib – Pfizer) to another class of drugs, TNF inhibitors, in treating RA. Patients taking Xeljanz were more likely to develop cancer, blood clots, or serious heart-related issues, or to die compared to those taking a TNF inhibitor such as Humira® (adalimumab).
- New and updated warnings are required on Xeljanz and its extended-release formulation, Xeljanz
XR, as well as the JAK inhibitors Olumiant® (baricitinib – Eli Lilly) and Rinvoq® (upadacitinib –
AbbVie).
- The warnings are not required on two other JAK inhibitors, Jakafi® (ruxolitinib – Incyte) and Inrebic® (fedratinib – Celgene), because these two drugs are not FDA-approved to treat arthritis or other inflammatory conditions.
- For patients who take or may soon start taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq, the FDA recommends that they:
- Tell their healthcare providers if they are a current or past smoker, have developed signs or symptoms of certain cancers, or have had heart problems, a stroke, or blood clots in the past.
- Seek immediate emergency assistance if signs or symptoms of a heart attack, stroke, or blood clots develop.
- The FDA asks healthcare providers to:
- To consider the benefits and risks for each individual patient before starting or continuing treatment with Xeljanz/Xeljanz XR, Olumiant, or Rinvoq.
- Reserve treatment of chronic inflammatory conditions with JAK inhibitors for patients who have had an inadequate response or intolerance to one or more TNF blockers.
- Counsel patients on the potential risks if they are taking or may start taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq.