Recalls and warnings
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.
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.
Glucagon (Baqsimi) nasal powder for the emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older. The drug, which comes in a single-use dispenser, is the first glucagon therapy approved for this condition that can be administered without an injection. Two studies, with 153 patients total, compared a single dose of the powder versus a single dose of glucagon injection in response to insulin-induced hypogly cemia, and the powder adequately increased blood sugar levels. Similar results were observed in a pediatric study of 48 patients over the age of 4 with type 1 diabetes. The drug is contraindicated in patients with pheochromocytoma or insulinoma. It carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia. The most common adverse reactions were nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Side effects are similar to that of injectable glucagon, with the addition of nasal and eye-related symptoms (e.g., nasal congestion, watery eyes).
Imipenem, cilastatin, and relebactam (Recarbrio) to treat adults with complicated urinary tract infections (UTIs) and complicated intra-abdominal infections. Efficacy was supported by data on the efficacy and safety of imipenem-cilastatin (a previously FDA-approved antibiotic) to treat complicated intra-abdominal infections and complicated UTIs, and the contribution of relebactam (a new beta-lactamase inhibitor) was assessed based on data from in vitro studies and animal models of infection. Safety of the combination treatment was studied in two trials, one each for complicated intra-abdominal infections and complicated UTIs. The most common adverse reactions were nausea, diarrhea, headache, fever, and increased liver enzymes. The drug should not be used in patients taking ganciclovir unless the benefits outweigh the risks, as generalized seizures have been reported. In addition, clinicians should avoid use in patients taking valproic acid or divalproex sodium, as a reduction in valproic acid level may lead to seizures.
First-time generic approvals
Pregabalin capsules and oral solution (25, 50, 75, 100, 150, 200, 225, 300 mg and 20 mg/mL) for the management of postherpetic neuralgia, fibromyalgia, and neuropathic pain associated with diabetic peripheral neuropathy or with spinal cord injury, as well as for the adjunctive treatment of partial-onset seizures in patients ages 17 years and older. (Brand name: Lyrica)
Tramadol hydrochloride tablets USP (100 mg) for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (Brand name: Ultram)
Note: The FDA states that drugs are not always commercially available immediately after approval.