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.

Endpoints News

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.