FDA warns of heart-re­lat­ed events, can­cer, blood clots, and death for JAK in­hibitors

The FDA on Wednes­day wrapped up its long-await­ed re­view of Pfiz­er’s large, ran­dom­ized tri­al eval­u­at­ing the safe­ty of its JAK in­hibitors Xel­janz and Xel­janz XR com­pared to tu­mor necro­sis fac­tor block­ers like En­brel and Hu­mi­ra. The re­sults aren’t good and spell trou­ble for more than just Pfiz­er’s drugs.

The agency said the tri­al re­sults show there is an in­creased risk of se­ri­ous heart-re­lat­ed events such as heart at­tack or stroke, can­cer, blood clots, and death with these arthri­tis and ul­cer­a­tive col­i­tis med­i­cines, and it’s up­dat­ing JAK in­hibitor la­bels while lim­it­ing their use to cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with the TNF block­ers.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER