Approvals for COVID-19 vaccines, epinephrine nasal spray

Recalls and warnings

A class I recall of the NIM vital nerve monitoring system due to the potential for false-negative response. During procedures, the device may fail to issue an electromyography tone when the probe is placed on a nerve. The use of the product may cause serious adverse health consequences, including nerve damage, facial nerve damage, nerve weakening, and nerve paralysis. There have been 10 reported injuries and no reports of death.

A class I recall of CADD-Solis and CADD-Solis VIP ambulatory infusion pump software by Smiths Medical due to multiple issues that may occur when using these infusion pumps without the latest software versions (any before v4.3). The problems include failure to alarm when there is an upstream occlusion, no audible alarm sound, and unresponsive stop and power keys, among others. There has been one reported injury and no reports of death.

A recall of 8,186 Vivo 45 LS ventilator devices by Breas Medical due to the potential for formaldehyde exposure to users under specific conditions. The company has not received any reports of injuries or adverse effects related to the issue.

A recall of two lots (J2L763 and J2L764) of 0.9% sodium chloride for injection USP 1,000 mL in E3 containers by B. Braun Medical Inc. due to the potential for particulate matter and fluid leakage.

A recall of one lot (N008235) of heparin sodium in 0.9% sodium chloride injection by Baxter due to the potential for elevated endotoxin levels. Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multiorgan failure, and death. Baxter has not received any reports of related adverse events.

A recall of the Volara system single-patient use circuit ventilator by Baxter due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. There have been no injuries reported.

A recall of one lot (550147301) of clonazepam orally disintegrating tablets, USP (C-IV), by Endo USA, Inc., due to mislabeling. On the cartons of some packs, the product strength is shown as 0.125 mg and not 0.25 mg. No adverse events have been reported.

A recall of one lot (24070381) of acetaminophen injection, 1,000 mg/100 mL (10 mg/mL), by Hikma Pharmaceuticals USA, Inc., because the overwrap that is labeled acetaminophen injection may actually include dexmedetomidine HCl injection (400 mcg/100 mL). The company has received one report of an adverse event.

A recall of one lot (AC2523005A) of Healthy Living Migraine Relief tablets, acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg, by Aurobindo Pharma USA, Inc., because the product is missing the manufacturer label. There is significant risk of misuse that could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient. To date, the company has not received any reports of adverse drug events related to this recall.

Miscellaneous

An update about the ongoing evaluation of quality and performance issues related to plastic syringes made in China, including an additional warning letter to Jiangsu Shenli Medical Production Co., Ltd., for quality system violations for syringe products. A warning letter was also issued to Jiangsu Caina Medical Co. Ltd. for quality system violations. Users should immediately transition away from using enteral syringes manufactured by Jiangsu Shenli unless use of these syringes is absolutely necessary.

A warning to health care professionals that the FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. The FDA encourages health care professionals and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe. Health care professionals should also be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available.

Approvals

Approval and emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2. The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals six months through 11 years of age.

Epinephrine nasal spray (Neffy) for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 30 kg. Approval was based on four studies of 175 healthy adults without anaphylaxis, which showed comparable epinephrine blood concentrations and increases in blood pressure and heart rate as epinephrine injection products. The single-dose spray is administered in one nostril and carries a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption. Common side effects include feeling jittery, tingling sensation, and fatigue, among others.

Guardant Health, Inc., Shield, a blood test intended to screen for colorectal cancer (CRC). The test is used for CRC screening in individuals at average risk for the disease who are 45 years of age or older. Patients with positive test results should have a colonoscopy since the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. It has limited detection (55% to 65%) of stage I CRC and does not detect 87% of precancerous lesions.

The first nalmefene hydrochloride auto-injector (Zurnai) for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The product delivers 1.5 mg of nalmefene under the skin or into muscle. It is a single-dose, prefilled auto-injector and is available only by prescription. Common adverse reactions include feeling hot, dizziness, nausea, headache, chills, and vomiting, among others.

Marketing authorization of DiaSorin Molecular LLC's Simplexa C. auris Direct, a molecular-based assay intended to detect Candida auris DNA from a skin swab of the armpit or groin from patients suspected of C. auris colonization. Test results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory information available to the clinician. The test is not intended to diagnose or monitor treatment for C. auris infection.

Norethindrone acetate and ethinyl estradiol (Femlyv), the first orally disintegrating tablet approved for the prevention of pregnancy. The drug has been approved for the prevention of pregnancy as a swallowable tablet since 1968. Common adverse reactions include a, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

Palopegteriparatide (Yorvipath) injection for subcutaneous use in adults with hypoparathyroidism. The treatment received an orphan drug designation. Effectiveness was evaluated in a placebo-controlled trial that enrolled 82 adults with hypoparathyroidism and found that 69% of the patients in the treatment group maintained calcium levels in the normal range versus 5% of the placebo group. The drug's label includes warnings about unintended changes in serum calcium levels. Adverse reactions included injection-site reactions, vasodilatory signs and symptoms, and headache.

Dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer. Dostarlimab-gxly was previously approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair-deficient or microsatellite instability-high. In a randomized placebo-controlled trial, median overall survival was 44.6 months and 28.2 months in the dostarlimab-gxly and placebo arms, respectively. Adverse reactions included anemia, increased creatinine levels, and peripheral neuropathy, among others.

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant.

First-time generic drug approvals

Palbociclib tablets, 75 mg, 100 mg, 125 mg, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy or fulvestrant in patients with disease progression following endocrine therapy. (Brand name: Ibrance)

Avanafil tablets, 50 mg, 100 mg, 200 mg, for the treatment of erectile dysfunction. (Brand name: Stendra)

0.9% sodium chloride irrigation USP, 1,000-mL, 2,000-mL, 3,000-mL single-dose containers, for all general irrigation, washing, rinsing, and dilution purposes that permit use of a sterile, nonpyrogenic electrolyte solution.

Phentermine and topiramate extended-release capsules, 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. (Brand name: Qsymia)

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