CPAP masks with magnets recalled

Recalls and warnings

A class I recall of continuous positive airway pressure (CPAP) masks with magnets by ResMed Ltd. due to possible magnetic interference with certain medical devices. Under certain circumstances when a magnet is in close proximity (less than two inches) to certain medical implants and devices, it might disrupt their function or position, possibly causing serious harm or death. The manufacturer is recalling the masks to update the labels and add more warnings and information. There have been six reported injuries and no deaths.

A class I recall of Mega Soft Universal Patient Return Electrode by Megadyne Medical Products, Inc., due to reports of patient burns. The recall updates instructions for use and product labeling to restrict use of the device to patients ages 12 years and older. The company received reports of burn injuries, including third-degree burns. There have been 99 reported injuries and no deaths.

A class I recall of tracheostomy care kits and related items by Busse Hospital Disposables, Inc., over sterility concerns. The kits contain sterile water-based products that fall under a recall by Nurse Assist of 0.9% sodium chloride and sterile water for irrigation. The recall does not affect the integrity of other kit components. Use of affected trays or kits may cause bloodstream infections, urinary tract infections, or respiratory infections and, in the worst-case scenario, sepsis and death. Similarly, there is a class I recall of Regard Operative Lap P&S surgical kit for containing the same fluids.

A class I recall of Ivenix large-volume pump, part of an infusion system, due to mechanical interference. Some units have mechanical issues with the fluid valve pins, located inside the pump's internal housing, and use of the affected product could cause underdosing, interruption in therapy, or delay of therapy, which could lead to serious harm or death.

A class I recall of the Medfusion Model 4000 syringe pump due to issues associated with earlier software versions of the medical pump. The recall, by Smiths Medical ASD Inc., is a correction, not a product removal. Issues may affect the alarm system, pump, control screen, and other parts of the pump. If undetected issues are present, the device may fail and delay or interrupt therapy, or the device may fail to deliver the therapy per the programmed setting. There has been one reported injury and no deaths related to the recall.

A class I recall of high frequency transport Phasitron breathing circuit kits by Percussionaire due to a product defect that causes over-pressurization. The kit is intended to be used with Percussionaire high-frequency percussive ventilation systems for either hospital or prehospital use where emergency care is being provided. Use of the affected kits may cause serious adverse health consequences, including lung injury, low blood pressure, cardiac arrest, and death. There have been three complaints regarding this issue, one injury, and no reports of death.

A boxed warning on denosumab (Prolia) about increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). Severe hypocalcemia appears to be more common in patients with CKD who also have a condition known as mineral and bone disorder. In patients with advanced CKD taking the drug, severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death.

A recall of 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags by Leiters Health due to the potential for superpotency. The lots may contain twice the labeled amount of drug due to a failure in the semiautomated equipment used to fill the IV bags. There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags could be associated with life-threatening adverse events. The company has not received any reports of adverse events related to this recall.

A letter to health care professionals to alert clinicians and facilities about the potential for exposure to certain chemicals, including formaldehyde, that may be released when General Electric HealthCare accessory components called the EVair or EVair 03 (Jun-air) compressors are used with certain ventilators. The FDA is not aware of reports of adverse events due to this issue.

A recall of one lot (F230169A) of Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg by Azurity Pharmaceuticals, Inc. The recall is due to a mislabeled package during manufacturing, which led to carbinoxamine maleate being found in one bottle labeled as dextroamphetamine sulfate.

Miscellaneous

A drug safety communication that an FDA preliminary evaluation found no evidence that use of glucagon-like peptide-1 (GLP-1) receptor agonists causes suicidal thoughts or actions. The communication is based on reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System and clinical trials. Because of a small number of suicidal thoughts or actions observed in both people using GLP-1 receptor agonists and in the comparative control groups, the FDA cannot definitively rule out a small risk and is continuing to look into this issue.

A shelf-life extension for newly manufactured naloxone hydrochloride (Narcan) 4-mg nasal spray products from three years to four years. The nasal spray, from Emergent BioSolutions, is the first naloxone product approved for over-the-counter use. The shelf life of products that were produced and distributed prior to this announcement is not affected and remains unchanged. Prescribers, patients, and caregivers are advised to continue to abide by the expiration date printed on each product's packaging and within the product's labeling.

An announcement that the FDA considers vaporized hydrogen peroxide to be an established method of sterilization for medical devices. The update is part of the agency's approach to reducing the use of ethylene oxide where possible.

An announcement that the FDA is working with French drugmaker Laboratoires Delbert to allow temporary imports of 3.5 million units of Extencilline (benzathine benzylpenicillin), a syphilis medication, to address ongoing shortages of penicillin G benzathine injectable suspension. Extencilline is not approved in the U.S.

Approvals

Casgevy, a cell-based gene therapy, for the treatment of patients ages 12 years and older with transfusion-dependent beta-thalassemia. To produce the therapy, patients' hematopoietic stem cells are modified by genome editing and then transplanted back into the patients where they engraft within the bone marrow and increase the production of fetal hemoglobin. Common side effects include mouth sores, febrile neutropenia, and decreased appetite.

Pembrolizumab (Keytruda) with chemoradiotherapy for patients with stage III-IVA cervical cancer. Efficacy was evaluated in KEYNOTE-A18, a multicenter, randomized, placebo-controlled trial enrolling 1,060 patients with cervical cancer who had not previously received definitive surgery, radiation, or systemic therapy. A statistically significant improvement in progression-free survival was seen in the overall population. Common adverse reactions in patients who received pembrolizumab with chemoradiotherapy were nausea, diarrhea, vomiting, urinary tract infection, and fatigue, among others.

Erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Efficacy was evaluated in Study BLC3001 Cohort 1, a randomized, open-label trial of 266 patients with mUC harboring selected FGFR3 alterations who had received one to two prior systemic treatments, including a PD-1 or PD-L1 inhibitor. Statistically significant improvements in overall survival, progression-free survival, and objective response rate were demonstrated for erdafitinib compared with chemotherapy. Adverse reactions included nail disorders, diarrhea, and stomatitis, among others.

Marketing authorization for the DermaSensor Inc. DermaSensor device. The prescription device is indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients ages 40 years and older to assist clinicians in determining whether to refer a patient to a dermatologist. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool.

Marketing authorization for the Genius Digital Diagnostics System with the Genius Cervical AI algorithm from Hologic, Inc. The device is intended to create and view digital images of scanned ThinPrep Pap Test glass slides. The algorithm can aid in cervical cancer screening for the presence of atypical cells; cervical neoplasia, including its precursor lesions; carcinoma; and all other cytological categories. Direct examination of the glass slide should be performed if there is still diagnostic uncertainty following a review of digital images. Digital images should also be interpreted by qualified cytologists and pathologists and considered with the patient's screening history, other risk factors, and professional guidelines.

First-time generic drug approvals

Teriparatide injection USP, 600 mcg/2.4 mL (250 mcg/mL) single-use prefilled pens, for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who cannot tolerate or have not responded to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who cannot tolerate or have not responded to other available osteoporosis therapy; and treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who cannot tolerate or have not responded to other available osteoporosis therapy. (Brand name: Forteo Injection)

Bromfenac ophthalmic solution, 0.07%, for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. (Brand name: Prolensa Ophthalmic Solution)

Note: The FDA states that drugs are not always commercially available immediately after approval.