Approvals for an oral anticoagulant, generic esomeprazole

Recalls

A recall of 1 lot of 0.9% sodium chloride injection, 250 mL, by Hospira due to 1 confirmed report of a particulate, which was identified as a human hair, sealed in the bag at the additive port area.

Approvals

Edoxaban (Savaysa) tablets to reduce the risk of stroke and embolism in patients with atrial fibrillation that is not caused by a heart valve problem, as well as to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anticlotting drug for 5 to 10 days. Safety and efficacy are based on a trial of 21,105 participants in which edoxaban reduced stroke and clot risk similarly to warfarin with less major bleeding. In a trial of DVT and PE patients, rates of symptomatic recurrent venous thromboembolism were similar to those with warfarin.

The most common side effects were bleeding and anemia. The drug carries a boxed warning about issues in specific patient groups, including those with atrial fibrillation and a creatinine clearance greater than 95 mL/min, and the risk of spinal or epidural hematomas.

The first generic version of esomeprazole (Nexium) to treat gastroesophageal reflux disease in adults and children ages 1 and older, as well as to reduce the risk of gastric ulcers associated with use of NSAIDs, to treat Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

The generic version will be dispensed with a medication guide mentioning the risk of stomach problems, including severe diarrhea, and that multiple daily doses of proton- pump inhibitors for a long period may cause an increased risk of bone fractures.

Glyxambi, a combination of empagliflozin (10 or 25 mg) and linagliptin (5 mg), to improve glycemic control in adults with type 2 diabetes. Efficacy was shown in trials comparing the combination pill plus metformin with each of the included drugs plus metformin. It does not treat type 1 diabetes or diabetic ketoacidosis and should not be taken by patients with severe renal impairment, end-stage renal disease, dialysis, or hypersensitivity reactions to linagliptin or empagliflozin. It has not been studied in patients with a history of pancreatitis, and there have been postmarketing reports of acute pancreatitis with linagliptin. The most common adverse reactions to the combination drug are urinary tract infection, nasopharyngitis, and upper respiratory tract infection.

A waiver for a nucleic acid-based influenza test (the Alere i Influenza A & B test) to be used outside of laboratories. It can now be distributed to sites including physicians' offices, emergency departments, and health department clinics. The test uses a nasal swab sample from a patient and provides results in about 15 minutes. Negative results do not rule out influenza virus infection; the test is intended to aid in diagnosis along with the evaluation of other risk factors. The test was first cleared in June 2014 as a prescription-only device.

The Maestro Rechargeable System, a weight-loss device for patients age 18 and older who have not been able to lose weight with a weight-loss program and who have a body mass index of 35 to 45 kg/m² with at least 1 other obesity-related condition, such as type 2 diabetes. The device targets the nerve pathway between the brain and the stomach and consists of a rechargeable electrical pulse generator, wire leads, and electrodes implanted surgically into the abdomen. In a trial, patients with the device lost 8.5% more weight in a year than controls. The clinical study did not meet its original end point, but the FDA concluded that the benefits outweighed risks of the device.

Serious adverse events include nausea, pain at the device site, vomiting, and surgical complications. Other adverse events include pain, heartburn, problems swallowing, belching, mild nausea, and chest pain.

Miscellaneous

The use of pain medicines during pregnancy should be carefully considered, the FDA concluded after a recent evaluation of the medical literature on the topic, including studies on prescription NSAIDs, opioids, and acetaminophen. The evidence is too limited to draw any definitive conclusions, so the agency's recommendations on use of pain medicines during pregnancy will remain the same at this time.