A class I recall of Trevo XP ProVue Retrievers by Stryker Neurovascular due to a risk that the core wire may break or separate when it is retracted during use. There have been 11 related reports of injury or illness and one death. The recall includes 1,258 devices distributed from Sept. 18, 2019, to July 7, 2020.
A class I recall of Rashkind Balloon Septostomy Catheters by Medtronic due to quality issues that may lead to the device breaking, separating, or failing during use. There have been two related reports of injury and one death. The recall includes 142 devices distributed from May 28, 2018, to Aug. 28, 2020. In addition, the company has stopped manufacturing and distributing the catheters for reasons unrelated to this recall.
A class I recall of fixed core wire guides by Cook Medical because five lots of wire guides dropped onto an unchecked surface during production, potentially causing them to bend out of shape or become dirty. There have been no related complaints or reported injuries or deaths. The recall includes 61 devices distributed on Sept. 9, 2020.
A recall of one lot of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (200 µg/50 mL [4 µg/mL] in 50-mL vials) by Fresenius Kabi due to containing trace amounts of lidocaine. The affected batch was distributed nationwide between April 9 and April 13, 2020.
An urgent device correction for all Sigma Spectrum Infusion Pumps by Baxter International Inc. because deviations from the specified cleaning methods may impair infusion pump functionality and performance. To date, the company has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. Among other actions to reinforce safety information regarding cleaning practices, the company will clarify the instructions for use to recommend a routine inspection to identify signs of residue buildup, corrosion, and depressed pins.
An expanded indication for baloxavir marboxil (Xofluza) to include postexposure prevention of influenza for patients ages 12 years and older after contact with an individual who has the flu. The drug, previously available only in tablet form, is also now available as granules for mixing in water. It was originally approved in 2018 for treating uncomplicated flu in patients ages 12 years and older who have been symptomatic for no more than 48 hours. A randomized, placebo-controlled trial evaluated its safety and efficacy for postexposure flu prevention. Overall, 1% of participants who received the drug had infection, fever, and at least one respiratory symptom from day 1 to day 10, compared with 13% of those who received a placebo. The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headache. Hypersensitivity reactions, including anaphylaxis, can also occur. The drug should not be co-administered with dairy products; calcium-fortified beverages; or laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminum, or zinc.
Marketing of a device intended for the temporary reduction of sleep disturbance related to nightmares. The device, called Nightware, is indicated for adults ages 22 years and older who have nightmare disorder or nightmares from post-traumatic stress disorder (PTSD). It is available by prescription only and is intended for home use. Using a smartwatch and a smartphone that are configured and logged into a software application and the Nightware server, the device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. It should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines, the FDA said.
First-time generic approvals
Levothyroxine sodium capsules (75 µg and 150 µg) for patients ages 6 years and older with hypothyroidism and pituitary thyrotropin suppression. (Brand name: Tirosint)
Fosfomycin tromethamine granules for oral solution (3 g [base] in single-dose packets) for the treatment of uncomplicated urinary tract infections in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. (Brand name: Monurol)
Pomalidomide capsules (1 mg, 2 mg, 3 mg, and 4 mg), in combination with dexamethasone, for the treatment of certain adult patients with multiple myeloma, of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy, and of patients with KS who are HIV negative. (Brand name: Pomalyst)
Atropine sulfate injection USP (1 mg/10 mL [0.1 mg/mL] in single-dose syringes) for the temporary blockade of severe or life-threatening muscarinic effects. (Brand name: None provided)
Note: The FDA states that drugs are not always commercially available immediately after approval.