A recall of daptomycin (Cubicin), 500-mg in 10-mL single-use vials, due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.
A recall of 1 lot of IPM wound gel by Edwards Pharmaceuticals because it may be contaminated with bacteria ( Pseudomonas putida).
A recall of 1 lot of 0.9% sodium chloride injection intravenous solution due to particulate matter found near the administration port.
A recall of sterile convenience surgical packs by Customed, Inc., because a potential defect due to adhesion could result in loss of product sterility and lead to infection.
A recall of 2 lots of Dianeal low-calcium peritoneal dialysis solution with 2.5% dextrose, 5000 mL, due to the presence of particulate matter, including oxidized stainless steel, garment fiber, and PVC.
A recall of certain lots of the Diamondback 360 peripheral orbital atherectomy system by Cardiovascular Systems because they may contain defective saline sheaths that could fracture during use.
A recall of 4-loop vascular retrieval snares by CloverSnare due to a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare.
Suvorexant (Belsomra), a new type of drug to treat insomnia. This orexin receptor antagonist should be taken no more than once per night, within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily. The most common adverse reaction is drowsiness. Testing has shown impaired next-day driving performance with the 20-mg dose, so patients taking that dose should be cautioned against driving or activities requiring full mental alertness, and those on lower doses should be made aware of the potential for impairment. Approval was based on 3 trials with more than 500 patients showing that those taking the drug fell asleep faster and spent less time awake than those on placebo. There is a risk of sleep-driving and other complex behaviors while not being fully awake, and the drug comes with a patient medication guide.
Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations. Approval was based on a trial of more than 10,000 patients finding that the DNA test detected 92% of colorectal cancers and 42% of advanced adenomas, compared to 74% and 24%, respectively, for fecal immunochemical testing. Simultaneously with FDA approval, Medicare issued a proposed national coverage determination for the test, which would cover it once every 3 years for asymptomatic, average-risk beneficiaries between 50 and 85 years.
A new indication for bevacizumab (Avastin) to treat persistent, recurrent, or metastatic cervical cancer. The new indication is for use in combination with paclitaxel and either cisplatin or topotecan. Approval is based on a study of 452 patients that found an average survival of 16.8 months on the drug compared to 12.9 months on chemotherapy alone. Common side effects are fatigue, decreased appetite, hypertension, hyperglycemia, and hypomagnesemia.
The first zinc transporter 8 autoantibody (ZnT8Ab) test to diagnose type 1 diabetes. The immune system of many people with type 1 diabetes produces ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. Approval was based on a clinical study of 569 blood samples (323 from patients with type 1 diabetes and 246 from patients with other conditions) in which the test diagnosed 65% of type 1 diabetes samples and incorrectly gave a positive result in less than 2% percent of the other samples.
The Prestige LP cervical disc to replace a diseased cervical disc that causes radiculopathy or myelopathy. It consists of a titanium-ceramic alloy that fits between the top and bottom surface of the cervical vertebrae. Approval was based on a study finding that the device had a success rate of 79.3% compared to 66.8% with cervical fusion.
Eliglustat (Cerdelga) to treat type 1 Gaucher disease. Approval is based on a trial finding improvements in spleen volume, liver volume, blood platelet count, and hemoglobin.