First rapid-acting insulin biosimilar approved

Recalls and warnings

An alert that Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Company, has issued a letter to affected customers providing updated instructions for use for Rotarex atherectomy systems. The helix portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure. Use of the device in certain anatomy and lesion types, as well as certain procedural factors, may cause the helix to fracture or break, requiring retrieval of a broken catheter and/or device fragment. The company has reported 30 serious injuries and four deaths associated with this issue, in addition to 115 cases requiring additional intervention following helix fracture and/or breakage.

A voluntary advisory notice from Olympus Corporation for the forceps/irrigation plug (isolated type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory. The company assessed the issue after receiving reports of adverse events involving patient injuries and one death.

A class I recall of certain models of single-use guide sheath kits by Olympus due to reports that the radiopaque tip of the guide sheath component fell off into the patient. Olympus's preliminary findings show that the tip detaches from the guide sheath when excessive force is applied as instruments are inserted into the guide sheath and/or if there is damage to the distal end of the sheath. The use of affected product may cause serious adverse health consequences, including bleeding and death. There have been 26 serious reported injuries and no deaths.

A class I recall of Tack Endovascular Systems by Philips due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the tack implant. All customers should stop using the endovascular system immediately. Philips will no longer distribute this system for use. There have been 20 reported injuries and no deaths.

A class I recall of Becker and Exacta external drainage and monitoring systems due to a risk for cracks and/or leaks in device stopcocks. The use of affected product may cause serious adverse health consequences, including leaks of cerebrospinal fluid, infections, and death. There have been 15 reported injuries and no deaths.

A class I recall to update use instructions for Allura and Azurion system patient tables by Philips after the company identified some situations that may result in the patient falling from the table. Use of the affected products may cause serious adverse health consequences, including contusions, hematoma, scratches, skin abrasions, stiffness, intracranial hemorrhage, lacerations, and death. There have been five reported injuries and no deaths.

A class I recall updating use instructions for Biosense Webster's Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack seen in the first 132 procedures after FDA approval in November 2024. Of 132 patients treated with the device during the U.S. external evaluation, four patients (about 3%) had a stroke or mini-stroke shortly after the surgery. Biosense Webster has reported four serious injuries associated with this issue.

A class I recall by Baxter Healthcare Corporation correcting the Life2000 ventilator system due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable. Use of the affected product may cause serious adverse health consequences, including deterioration in respiratory status leading to hypoxia with resulting cognitive impairment, lethargy, changes in blood pressure and heart function, or potential coma and death. There have been no reported injuries.

A class I recall of the JMC5A Ni/TruAire-5 oxygen concentrator by Jiangsu Jumao X-Care Medical Equipment Co., Ltd., due to incidents of melting and fire during use. The cause remains under investigation. Use of the affected products may cause serious adverse health consequences, including burns and possibly death. There have been no reported injuries.

A class I recall of integrated arterial catheters by Medline Industries, LP, due to a manufacturing issue that caused excess material to be present on the catheter hub. If a catheter with excess material at the hub is used, that material could detach, potentially entering the body at the place it is inserted or entering the bloodstream. Use of the affected product may cause serious adverse health consequences, including embolism and death. There have been no reported injuries.

A class I recall of Phasitron breathing circuit kits by Sentec/Percussionaire after the company received a customer report that the venturi component of the kit stopped oscillating during use. Use of the affected product may cause serious adverse health consequences, including acute respiratory failure, hypoxia, hypercapnia, potential brain damage, heart complications, increased risk of pneumonia, and death. There have been no reported injuries.

A class I recall updating instructions of the Impella RP with SmartAssist and Impella RP flex with SmartAssist by Abiomed Inc. due to a risk that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment, or removal. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop. This may trigger alarms and cause a loss of certain heart and blood pressure readings. There have been no reported injuries.

A class I recall of the vaporizers sevoflurane Maquet filling and sevoflurane quick-fil by Getinge after receiving reports of discoloration and/or corrosion after use with low-water-content sevoflurane manufactured by Piramal or Baxter. Sevoflurane used in the vaporizer may degrade to hydrogen fluoride. This toxic and hazardous acid may present a risk to both patients and health care professionals if it is inhaled or comes into contact with the skin. This is an expansion of an earlier recall. There have been no reported injuries.

A recall of one lot of fentanyl transdermal system patches to the consumer level by Alvogen, Inc., because patches could be multistacked, adhered one on top of the other, in a single product pouch. Application of a multistacked 25 mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. The company has received a report of one serious adverse event related to this recall.

A recall of one lot each of potassium chloride injection bags with overwrap labels, 10 mEq, packaged in cases of potassium chloride injection, 20 mEq, by ICU Medical, Inc., to the user level. The company has received a customer report that bags of potassium chloride injection, 20 mEq, have incorrect overwrap labels reading 10 mEq. If health care professionals mistakenly calculate the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride.

A recall of one lot (24020027) of phenylephrine hydrochloride injection, USP, 10 mg/mL (pharmacy bulk package), at the hospital/institutional level by Provepharm Inc. based on a customer report from a pharmacy about visible black particulate matter in a single-sealed vial of the product.

A recall of one lot (3200240) of ChloraPrep clear 1-mL applicators by BD due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. There have been no reported adverse events associated with this issue.

A recall of one lot (024122661A1) of SinuCleanse soft-tip squeeze-bottle nasal wash system due to confirmed contamination with Staphylococcus aureus. Use of the contaminated system can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries caused by nasal irrigation. No adverse events have been reported related to this recall.

A recall of three lots of phenylephrine, 40 mg, added to 0.9% sodium chloride, 250 mL, in 250-mL excel bags. The product is being recalled to the hospital level because Central Admixture Pharmacy Services was notified by their raw material supplier that visible black particulate matter was detected in a single sealed vial of phenylephrine hydrochloride. The company has not received any reports of adverse events or injuries associated with this recall.

Miscellaneous

An alert to health care professionals to inform patients and their caregivers that people who rely on smartphone-compatible diabetes devices should periodically check smartphone settings to ensure that they can receive critical alerts and confirm that diabetes devices still provide alerts as expected through their smartphones after making any hardware or software updates or connecting external hardware.

An alert on the safety and effectiveness of breast implants that includes information on medical device reports received through June 30, 2024, for systemic symptoms in women with breast implants and breast implant-associated anaplastic large-cell lymphoma.

An update to the Risk Evaluation and Mitigation Strategies (REMS) program for clozapine, a schizophrenia treatment, stating that the FDA does not expect prescribers, pharmacies, and patients to participate in the REMS program for the drug or to report results of absolute neutrophil count (ANC) blood tests before dispensing. The FDA still recommends that prescribers monitor patients' ANC according to the frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing boxed warnings.

An additional clearance for Tandem Diabetes Care, Inc.'s, control-IQ+ technology. The software-only, prescription use device is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. This clearance allows the device to be used to manage type 1 diabetes in individuals ages 2 years and older and type 2 diabetes in those ages 18 years and older. The prior version was approved only for type 1 diabetes.

Approvals

Insulin aspart-szjj (Merilog) as a biosimilar to insulin aspart (Novolog) to improve glycemic control in patients with diabetes. The rapid-acting human insulin analog is the first rapid-acting insulin biosimilar product to gain approval.

Chenodiol (Ctexli) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Chenodiol is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. Efficacy was evaluated in a randomized controlled trial. At 24 weeks, chenodiol, 250 mg three times per day, resulted in significant reduction in plasma cholestanol and urine 23S-pentol levels compared to placebo. The treatment carries a warning for liver toxicity in all patients and increased risk for liver damage in patients with pre-existing liver disease or bile duct abnormalities. Common side effects include diarrhea, headache, abdominal pain, constipation, hypertension, muscular weakness, and upper respiratory tract infection. The treatment received an orphan-drug designation.

Vimseltinib (Romvimza), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant-cell tumor for which surgical resection could cause worsening functional limitation or severe morbidity. A double-blind multicenter trial found an overall response rate of 40% in the vimseltinib arm versus 0% in the placebo arm at week 25, along with statistically significant improvements in active range of motion, patient-reported physical functioning, and patient-reported pain in the vimseltinib arm. Common adverse reactions included increased alanine and aspartate aminotransferase levels, periorbital edema, fatigue, rash, increased cholesterol levels, peripheral edema, facial edema, decreased neutrophils, decreased leukocytes, and pruritus.

Mirdametinib (Gomekli), a kinase inhibitor, for patients 2 years of age and older with neurofibromatosis type 1 and symptomatic plexiform neurofibromas not amenable to complete resection. The confirmed overall response rate was 41% for adults and 52% in the pediatric cohort in a multicenter single-arm trial. Common adverse reactions included rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. The treatment received an orphan-drug designation.

Brentuximab vedotin (Adcetris) in combination with lenalidomide and a rituximab product for adults with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL] not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma) after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem-cell transplantation or CAR T-cell therapy. The treatment demonstrated a statistically significant improvement in overall survival, progression-free survival, and objective response rate in a randomized, double-blind, placebo-controlled trial. Common adverse reactions included fatigue, diarrhea, peripheral neuropathy, rash, pneumonia, and COVID-19.

Treosulfan (Grafapex), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem-cell transplantation in patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). A randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation found hazard ratios for overall survival with treosulfan of 0.67 in the randomized population, 0.73 in patients with AML, and 0.64 in patients with MDS. Common adverse reactions included musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting.