First Ebola vaccine approved; FDA enforcement on e-cigs

Recalls, warnings, and alerts

A class I recall of the VNS Therapy SenTiva Generator System by LivaNova due to an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy. The manufacturer has received 14 reports of such errors, and four patients have required early revision surgery for failed devices. No related deaths have been reported.

An alert regarding cybersecurity vulnerabilities in certain Clinical Information Central Stations and Telemetry Servers by GE Healthcare. The manufacturer has issued instructions for risk mitigation and how to find software updates or patches when they become available. Clinicians should work with staff at their facilities to determine if a medical device used by patients may be affected and, if so, how to reduce associated risk.

An alert that clinical trial results have shown a possible increased risk of cancer with lorcaserin (Belviq, Belviq XR). The cause of cancer is uncertain, and the FDA cannot conclude that the weight management medicine contributes to cancer risk. The agency is continuing to evaluate the results and will communicate its final conclusions and recommendations after completing its review.

A recall of LemonPrep, PediaPrep, and Wave Prep 4-ounce tubes and single-use cups and Cardio Prep single-use cups by Mavidon due to potential contamination with Burkholderia cepacia. Hospitals, distributors, and clinics that have any of these products should immediately stop using them and quarantine them.

A recall of all unexpired sterile drug products by FUSION IV Pharmaceuticals Inc. (doing business as AXIA Pharmaceutical) due to a lack of sterility assurance. Recalled products have been found to be inconsistent with federal guidelines.

Miscellaneous

A final enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children. The policy applies to e-cigarette flavors including fruit and mint but does not apply to tobacco or menthol flavors. The FDA also expanded its youth e-cigarette prevention campaign to include stories from teenagers addicted to nicotine.

Seizure of 44 websites advertising the sale of illicit vaping cartridges containing tetrahydrocannabinol, the primary psychoactive component of cannabis. The action, conducted by the FDA and the Drug Enforcement Administration as part of Operation Vapor Lock, reflects ongoing work by authorities to investigate the supply chain of vaping products associated with recent lung injuries and deaths.

Approvals

The first vaccine (Ervebo) approved for the prevention of Ebola virus disease caused by Zaire ebolavirus. The vaccine is administered as a single-dose injection to adults and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus.

Ubrogepant (Ubrelvy) tablets for the acute treatment of migraine with or without aura in adults. The drug is the first in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine. The drug is contraindicated for coadministration with strong CYP3A4 inhibitors. It is not indicated to prevent migraine.

Fam-trastuzumab deruxtecan-nxki (Enhertu) to treat adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The HER2-directed antibody and topoisomerase inhibitor conjugate is indicated for patients who have received two or more prior anti-HER2-based regimens in the metastatic setting.

Teprotumumab-trbw (Tepezza), the first drug approved to treat adults with thyroid eye disease. The rare disease is associated with outward bulging of the eye that can cause a variety of symptoms, such as eye pain, double vision, light sensitivity, or difficulty closing the eye.

Tazemetostat (Tazverik) to treat adults and adolescents ages 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Patients treated with the drug are at increased risk of secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.

First-time generic approvals

Mirabegron extended-release tablets (25 mg) to treat overactive bladder with symptoms of urge incontinence, urgency, and urinary frequency. (Brand name: Myrbetriq)

Diazoxide oral suspension (50 mg/mL) to manage hypoglycemia due to hyperinsulinism associated with certain conditions. (Brand name: Proglycem)

Penicillamine tablets (250 mg) to treat Wilson's disease, cystinuria, and severe, active rheumatoid arthritis that has failed to respond to an adequate trial of conventional therapy. (Brand name: Depen)

Ziprasidone mesylate for injection (20 mg [base]/mL in single-dose vials) for the acute treatment of agitation in patients with schizophrenia. (Brand name: Geodon)

Alvimopan capsules (12 mg) to accelerate the time to upper and lower GI system recovery following partial large- or small-bowel resection surgery with primary anastomosis. (Brand name: Entereg)

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