Recalls and warnings
A recall of 1 lot of fluconazole injection, 200 mg per 100 mL, because of an impurity result detected during routine quality testing. The impurity was identified as metronidazole. The impurity could decrease effectiveness, and patients taking this drug concomitantly with metronidazole may receive an increased dose of the latter.
A recall of 1 lot of amikacin sulfate injection, 1 g/4 mL (250 mg/mL) vials, because of glass particulate identified in 1 vial, which could result in local irritation or swelling, or more serious consequences such as blockage and clotting in blood vessels. The manufacturer has not received any reports of adverse events.
A recall of 1 lot of 8.4% sodium bicarbonate injection, 50 mEq (1 mEq/mL), 4.2 g (84 mg/mL), 50 mL because of the presence of particulate matter. The manufacturer has received no reports of related adverse events and has launched a root-cause investigation.
A class I recall of 47,140 Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits because the sheath body may separate from the sheath hub. If this separation occurs, the patient may bleed from the sheath, potentially causing substantial blood loss or exsanguination if not promptly addressed. Interruption or loss of intra-aortic balloon pump treatment may also occur. When the products were recalled, 13 adverse events had been reported, including 6 serious injuries and 1 death.
A safety notice on the MitraClip Delivery System because of reports of users being unable to separate the implantable clip from the delivery system. An investigation by the manufacturer determined that the system's arm positioner was not returned to the required neutral position by the operator during the deployment sequences, which prevented the clip from detaching. All of these cases (0.17% incidence) resulted in surgical interventions. There was 1 patient death as a result of severe comorbidities following surgery. The manufacturer is not removing devices from the market; instead, it will require training of all physicians who implant the device.
Recombinant coagulation factor IX (Idelvion), an albumin fusion protein, to treat hemophilia B. To reduce the frequency of bleeding episodes, the intravenous drug may be used perioperatively, prophylactically, or as needed. Two trials involving 90 adult and pediatric patients ages 1 to 61 showed the drug to be effective at controlling bleeding episodes and managing perioperative bleeding. When used as prophylaxis, it led to a significant reduction in the rate of spontaneous bleeding episodes per year. No safety concerns were identified, and the most common side effect was headache.
Obiltoxaximab (Anthim) in combination with appropriate antibacterial drugs for inhalational anthrax. The monoclonal antibody is also approved to prevent inhalational anthrax when alternative therapies are not available. The drug was approved based on efficacy findings from animal research (i.e., survival at the end of the studies). Compared to animals treated with placebo, more animals treated with the drug lived, and using the drug in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone. Product safety was evaluated in 320 healthy human volunteers, and the most common side effects were headache, pruritus, upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling, and pain at the infusion site. A boxed warning indicates that the drug can cause allergic reactions, including anaphylaxis.
The Fenix Continence Restoration System to treat fecal incontinence in patients without medical or other surgical options. The system has 3 components: an implant, an anal sphincter sizing tool, and an introducer tool. In a study of 35 adults, 62.9% of participants experienced a reduction of fecal incontinence episodes by half or more after 1 year. In addition, 54.3% experienced a reduction in fecal incontinence days by half or more, and 37.1% experienced a reduction in urgent episodes by half or more. Adverse events include pain, infection, impaction or defecatory disorder, device erosion, device removal/reoperation, and bleeding. The system should not be implanted in patients with titanium allergies, and the sizing and introducer tools should not be used in those with allergies to titanium, stainless steel, nickel, or ferrous materials. The implant is considered magnetic resonance unsafe.
A proposal to ban most powdered gloves. Although the use of these gloves is decreasing, the FDA stated that they pose a risk of illness or injury to clinicians, patients, and other individuals who are exposed to them. Powder makes gloves easier to don and doff but poses risks. For instance, aerosolized glove powder on natural rubber latex gloves may cause respiratory allergic reactions, and glove powder used with all types of gloves can cause side effects such as severe airway inflammation, wound inflammation, and postsurgical adhesions. The proposed ban applies to powdered surgeons' gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeons' gloves. If finalized, the ban would remove these products from the market.