RSV vaccine news, Entresto generic approved

This column reviews recent recalls, alerts, and approvals.

Recalls and warnings

A class I recall of HeartMate 3 left ventricular assist system by Abbott for risk of blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff, which may lead to longer than expected surgery, bleeding, right-heart failure, or air embolism. The company has reported 81 incidents, including 70 injuries and two deaths.

A class I recall of specific lots of Route 92 Medical products containing Tenzing 7 delivery catheters for multiple instances of distal tip separation, which can cause delays in surgery, harm to blood vessels, or catheter fragments remaining in the body. There have been two reported injuries and one death.

A class I recall of version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 insulin pump with control-IQ technology by Tandem Diabetes Care, Inc. An issue with the software may cause a cycle in which the mobile app crashes and is automatically relaunched by the iOS operating system, which may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. There have been 224 reported injuries and no deaths.

A class I recall of the BioZorb Marker, an implantable radiographic marker used to mark soft tissue for future medical procedures, by Hologic, Inc., due to reported complications and adverse events, including pain, infection, rash, device migration, device erosion, seroma, discomfort, and the need to remove the device. There have been 71 reported injuries and no reports of death.

A class I recall of the VITEK 2 AST Kit by BioMérieux, Inc., due to a higher concentration of ceftriaxone in two wells. Use may cause serious adverse effects, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death. The recall is a correction, not a product removal. There have been no reports of injuries or deaths.

A class I recall of Trilogy Evo continuous ventilators by Philips Respironics Inc., due to a software-related risk of power malfunction. These ventilators can issue a "battery depleted" or "loss of power" alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms. Use of the affected devices may result in ventilators powering down and not delivering therapy to the patient, even though the battery is not depleted, which could cause serious adverse health consequences, including hypoventilation and death. There have been no reports of serious injury or death related to this issue.

A class I recall of the Optum Nimbus II Plus, also known as the Nimbus II–Optum Homecare Infusion, by OptumHealth Care Solutions, LLC, in response to an earlier recall by InfuTronix of related devices. Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier, interruptions or delays in therapy from unnoticed occlusions or leaks, and underdosing of vital medications and fluids. No additional injuries or deaths related to this issue beyond those in the original InfuTronix recall have been reported.

A safety communication about the need to stop using unauthorized plastic syringes made in China, including those by Jiangsu Shenli Medical Production Co. Ltd.


A respiratory syncytial virus (RSV) vaccine (mRESVIA) for prevention of lower respiratory tract disease caused by RSV in those 60 years of age and older. mRESVIA is an mRNA-based vaccine manufactured by Moderna.

An expanded indication for Arexvy, the RSV vaccine by GlaxoSmithKline Biologicals, to prevent lower respiratory tract disease caused by RSV in individuals ages 50 through 59 years who are at increased risk. The vaccine has been approved for patients ages 60 years of age and older since May 2023.

Lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle-cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The drug also received an accelerated approval for adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.

Accelerated approval of tarlatamab-dlle (Imdelltra) for extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was evaluated in 99 patients with relapsed/refractory ES-SCLC with disease progression following platinum-based chemotherapy who were enrolled in an open-label multicenter trial. The treatment carries a boxed warning for serious or life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.

Expansions to the indications for use of the Beckon, Dickinson and Co. Onclarity HPV Assay and the Roche Molecular Systems, Inc. cobas HPV Test. The expanded indications allow for the patient to self-collect a vaginal swab in a health care setting when the patient and clinician determine that it is not possible for the clinician to collect a cervical specimen.

The first two interchangeable biosimilars to aflibercept (Eylea), aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz). Aflibercept products work by inhibiting vascular endothelial growth factors (VEGF) and preventing new or abnormal blood vessel growth within the eye. By blocking VEGF, these products can help to slow down or reduce damage to the retina and preserve vision.

First-time generic drug approvals

Sacubitril/valsartan tablets indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients ages one year and older. (Brand name: Entresto).

Eribulin mesylate injection, 1 mg/2 mL (0.5 mg/mL) single-dose vial, for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease or those with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (Brand name: Halaven injection)

Nicardipine hydrochloride in 0.83% sodium chloride injection, 40 mg/200 mL (0.2 mg/mL), in single-dose containers and nicardipine hydrochloride in 0.86% sodium chloride injection, 20 mg/200 mL (0.1 mg/mL), in single-dose containers, for the short-term treatment of hypertension when oral therapy is not feasible. (Brand name: Cardene I.V. premixed injection)

Estradiol gel, 0.06%, for the treatment of moderate to severe vasomotor symptoms due to menopause and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. (Brand name: EstroGel)

Deflazacort oral suspension, 22.75 mg/mL, for the treatment of Duchenne muscular dystrophy in patients 5 years of age and older. (Brand name: Emflaza)

Midostaurin capsules, 25 mg, for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive and for those with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast-cell leukemia. (Brand name: Rydapt)

Metronidazole vaginal gel, 1.3%, for the treatment of bacterial vaginosis in females 12 years of age and older. (Brand name: Nuvessa Vaginal Gel)

Finasteride and tadalafil capsules, 5 mg/5 mg, to initiate treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks. (Brand name: Entadfi)

Valbenazine capsules, 40 mg, 60 mg, 80 mg, for the treatment of adults with tardive dyskinesia. (Brand name: Ingrezza)

Doxycycline capsules, 40 mg, for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. (Brand name: Oracea)

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