A new boxed warning about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. The changes follow the FDA's review of interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis that examined both this higher dose and a lower dose of the medicine. The 10-mg twice-daily dose is not approved to treat rheumatoid arthritis or psoriatic arthritis. Clinicians should discontinue the drug and promptly evaluate patients if they have symptoms of thrombosis and, when treating ulcerative colitis, use tofacitinib at the lowest effective dose while limiting use of the 10-mg twice-daily dosage to the shortest duration needed.Pregabalin powder
A class I recall of the IntraClude Intra-Aortic Occlusion Device by Edwards Lifesciences due to a risk of balloon rupture during use. The manufacturer has received 22 complaints related to balloon rupture or puncture, and three deaths have been reported. The recall includes 757 devices distributed from May 1, 2017, to Feb. 19, 2019.

A class I recall of Intra-Aortic Balloon Pumps (IABP) by Maquet/Datascope due to potential battery failure. All models and lot numbers of the Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP, and CS100/100i IABP are included in the recall, which includes 22,853 devices overall.

A class I recall of Hamilton-G5 Ventilators by Hamilton Medical AG due to the potential for an error message to cause the ventilator to stop working and enter an ambient state. The manufacturer has received 14 complaints associated with the “Panel connection lost” error message, although no related injuries or deaths have been reported. The manufacturer developed new software for the 4,338 affected devices, distributed from Nov. 29, 2007, to Oct. 31, 2018.

A class I recall of enFlow Fluid Warming System disposable cartridges by Vyaire Medical due to potential risk of exposure to elevated levels of aluminum. The system is indicated for warming blood, blood products, and IV solutions prior to administration. Aluminum may elute from the warmer into the fluids, thereby exposing patients to unsafe levels of the metal. The recall includes about 2.9 million devices distributed from Jan. 4, 2016, to March 7, 2019.