Updated boxed warning for arthritis, ulcerative colitis drugs
This column reviews details on recent recalls, alerts, and approvals.
Recalls and warnings
A class I recall of AMSORB Plus Prefilled G-Can 1-L canisters by Armstrong Medical Limited due to reduced gas flow to patients. The canisters attach to a ventilator or anesthesia machine and provide a chemical substance to absorb carbon dioxide. There have been no related injuries or deaths. The recall includes 214,032 devices distributed from Oct. 22, 2020, to June 9, 2021.
A class I recall of the SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands by Cordis Corporation due to the potential for the marker bands to move or dislodge during procedures. There have been 167 complaints, eight injuries, and no deaths reported for this issue. The recall includes 25,000 units distributed from Jan. 1, 2019, to July 20, 2021.
Revisions to the boxed warning for certain Janus kinase inhibitors. The FDA is requiring revisions to the boxed warning for the arthritis and ulcerative colitis medicine tofacitinib (Xeljanz/Xeljanz XR), as well as two other Janus kinase inhibitors that treat arthritis, baricitinib (Olumiant) and upadacitinib (Rinvoq), to include information about the risks of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death. The change is based on an FDA review of a large, randomized safety clinical trial of tofacitinib, which found an increased risk of such adverse events. While baricitinib and upadacitinib have not been studied in similar large safety trials, they share mechanisms of action with tofacitinib and may be associated with similar risks, the FDA said.
A recall of nine lots of cefazolin (2 g in 20-mL syringe for injection) and two lots of cefazolin (3 g in 100-mL 0.9% sodium chloride bag for injection) by IntegraDose Compounding Services LLC due to a lack of sterility assurance. Affected lots were distributed nationwide to hospitals from Aug. 12 to Sept. 15, 2021.
First generic drug approvals
Linagliptin tablets (5 mg) as an adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes. (Brand name: Tradjenta)
Linagliptin and metformin hydrochloride tablets (2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5/1,000 mg) as an adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes. (Brand name: Jentadueto)
Ibuprofen and famotidine tablets (800 mg/26.6 mg) for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of upper GI ulcers. (Brand name: Duexis)
Tofacitinib extended-release tablets (11 mg and 22 mg) for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, or moderately to severely active ulcerative colitis. (Brand name: Xeljanz XR)
Enalapril maleate oral solution (1 mg/mL) to treat patients with symptomatic heart failure or asymptomatic left ventricular dysfunction and to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. (Brand name: Epaned)
Note: The FDA states that drugs are not always commercially available immediately after approval.