Recalls and warnings
A warning to consumers not to purchase and immediately stop using certain over-the-counter eyedrops due to the potential risk of eye infections that could lead to partial vision loss or blindness. FDA investigators found unsanitary conditions in manufacturing facilities and positive bacterial test results from environment samples in the facilities. Affected products include those from CVS Health, Cardinal Health, Rite Aid, Target, Velocity Pharma, and Walmart.
A class I recall of the Olympus High Flow Insufflation Unit because it may overinflate air into the body with no warning or alarm. Malfunction of the device, which is used during laparoscopic or endoscopic surgeries, may cause serious adverse health consequences, including air embolism, arrythmias, collapsed lung, kidney or urinary problems, lack of oxygen to organs, and air trapped under the skin. There have been reports of 21 malfunctions, 10 serious injuries, and one death.
A new warning on antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS), which may start as a rash but can quickly progress, resulting in injury to internal organs, hospitalizations, and death. Thirty-two serious cases of DRESS following treatment with levetiracetam have been reported worldwide along with 10 for clobazam.
A warning to monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA received medical device reports associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people were using the machines. Between Aug. 1, 2023, and Nov. 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 reports received in the previous three years.
A class I recall of Monoject Disposable Syringes due to incompatibilities with syringe pumps. Single-use Luer lock syringes, 1, 6, 12, 20, 35, and 60 mL, have been recalled due to dimensional changes between these devices and the devices previously branded “Covidien Monoject syringes.” The company has received 15 reports of delayed therapy and 13 reports of inaccurate volume/rate dispensing. Relatedly, there is a Class I recall of Alaris infusion pumps due to compatibility issues with Cardinal Health Monoject Syringes. Use of incompatible syringe sizes can result in inaccurate fluid delivery, delayed generation of occlusion alarms, and other potential problems. There have been 13 reported injuries and no reports of death.
A class I recall of Sanxin Single-Use Syringes due to blood or heparin leaking back or from the syringe. There have also been reports of an unknown black material inside the syringe. Use of the affected syringes can cause bloodstream infections, loss of blood due to leakage, and incorrect heparin dosages that may lead to blood clotting, embolism, and death. Thirty-seven incidents have been reported, with no injuries or deaths.
A class I recall of Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues, which may cause the pumps to fail to detect air in the line when running on battery power. There are no reports of injury or death associated with this issue.
A class I recall of the Infusomat Space Large Volume Pump, Wireless, and Infusomat Space Large Volume Pump, Non-Wireless, battery pack due to a faulty occlusion alarm that may sound when no occlusion exists on certain models. There have been 51 complaints, one reported injury, and one death related to this recall.
A class I recall of pressure injectable catheter kits from Teleflex and Arrow International for mislabeling due to the presence of chlorhexidine. The product code and name are incorrectly listed as non-chlorohexidine coated on the lids of affected kits.
A class I recall of V60 and V60 Plus ventilators from Philips Respironics because their power management printed circuit board assemblies do not meet ventilator standards. Use of the affected ventilators may cause serious adverse health consequences, including loss of ventilator function and death. There have been no reports of death or injuries related to this recall.
A class I recall of some hemodialysis machines from Fresenius Medical Care's 2008 Series because patients may be exposed to non-dioxin-like polychlorinated biphenyl acids that leach from some silicone tubing in the machine and dialysate lines. Because the levels of these chemicals decrease over the first month during routine clinical use, the company is updating machines that may not have been used for at least 36 days. The use of affected machines may cause serious consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems, and male infertility.
A class I recall of McGRATH MAC video laryngoscopes due to stolen defective products. Covidien LLC is recalling the devices to remove stolen defective models that have been offered for sale illegally on social media platforms. No injuries or deaths have been reported.
A class I recall of Baxter Novum IQ Syringe Pump for potential underdosing. The problem has been traced to a software error that may miscalculate volume after the pump detects a blockage. The recall is a correction, not a product removal, and the firm is developing a software fix. There have been no reports of serious injuries or death associated with the problem.
A class I recall of Asensus Senhance Surgical System due to malfunctions with unintended movement of the robotically assisted surgical device. There has been no patient impact or harm that has occurred due to this issue; however, the potential for critical tissue trauma is possible.
A class I recall of several lots of VariSoft infusion sets due to damage to the connector piece causing unexpected disconnections. The sets are manufactured by Unomedical A/S and are used with Tandem insulin pumps in patients with diabetes. The defect could lead to hyperglycemia if a disconnection is not detected and reconnected promptly. One injury has been reported.
A recall and warning of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP by Nurse Assist, LLC, due to potential nonsterility.
A recall of 8.4% sodium bicarbonate injection, USP, 50 mEq/50 mL, midazolam in 0.8% sodium chloride injection, 100 mg/100 mL, and ELCYS (cysteine hydrochloride injection), USP 500 mg/10 mL, by Exela Pharma Sciences, LLC, due to the presence of silicone particulate matter observed during routine inspection.
A recall of one lot of Vitrakvi (larotrectinib) oral solution 20 mg/mL in 100-mL glass bottles by Bayer due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
A recall of two lots of sandimmune oral solution (cyclosporine oral solution, USP), 100 mg/mL, due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. Novartis has not received any reports of adverse events.
A safety communication on the risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The FDA received reports from clinical trials and/or postmarketing adverse event data sources of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The FDA notes the overall benefits of the immunotherapies outweigh their potential risk and is evaluating the need for regulatory action.
A labeling update for Becton, Dickinson and Company surgical mesh products to include updated warnings and precautions. The safety and effectiveness of surgical mesh in breast surgery, including in augmentation and/or reconstruction, has not been determined by the FDA. The FDA does not recommend reoperation or removal of implanted surgical mesh in asymptomatic patients.
A safety communication that the FDA is evaluating the potential for device failures, including leaks, breakage, and other problems, with plastic syringes manufactured in China. The issue does not include glass syringes, prefilled syringes, or syringes used for oral or topical purposes.
A new indication for tirzepatide (Zepbound) to be used for chronic weight management in adults with obesity or overweight and at least one weight-related condition. The dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist injection should be used in conjunction with a reduced calorie diet and increased physical activity. Tirzepatide is already approved to treat type 2 diabetes.
Marketing authorization for the first at-home chlamydia and gonorrhea tests. The Simple 2 Test is marketed by LetsGetChecked and is available over the counter.
Ustekinumab-auub (Wezlana), a biosimilar to ustekinumab (Stelara), for adult patients with inflammatory disease, including moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis.
The first vaccine to prevent disease caused by chikungunya virus (Ixchiq) for adults at risk of exposure to the virus. The vaccine, which received accelerated approval, was deemed safe based on results of two clinical studies carried out among 3,500 participants who received an injection. The prescribing information includes a warning that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.
Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter.
ReCor Medical's Paradise Ultrasound Renal Denervation System, the first designated device to treat patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
Marketing authorization for Control-IQ Technology, a device intended for use with compatible integrated continuous glucose monitors and alternate controller-enabled insulin pumps to manage type 1 diabetes. The technology can automatically increase, decrease, and suspend delivery of basal insulin based on integrated continuous glucose monitor readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
New indications for pembrolizumab (Keytruda). One is for its use with platinum-containing chemotherapy as neoadjuvant treatment and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable non-small-cell lung cancer (NSCLC). The most common adverse reactions were nausea, fatigue, neutropenia, anemia, constipation, decreased appetite, decreased white blood cell count, musculoskeletal pain, rash, cough, vomiting, diarrhea, and dyspnea. The second is for its use with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer. The third is with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Toripalimab-tpzi (Loqtorzi) with cisplatin and gemcitabine for the first-line treatment of metastatic or recurrent, locally advanced nasopharyngeal carcinoma.
Adzynma, the first recombinant protein product indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura. The most commonly reported side effects in trials were headache, diarrhea, migraine, and abdominal pain, among others. The treatment received an orphan drug designation.
Capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor (EGFR) 2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alteration, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Fruquintinib (Fruzaqla) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor therapy, and, if RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor therapy. Two trials found median overall survival was significantly greater in treatment arms compared with placebo arms. Common adverse reactions included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
Enzalutamide (Xtandi) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Repotrectinib (Augtyro) for locally advanced or metastatic ROS1-positive NSCLC. It is the first FDA approval including patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naive.
Nirogacestat (Ogsiveo) tablets for adult patients with progressing desmoid tumors who require systemic treatment. The treatment is the first drug approved for patients with desmoid tumors. Approval is based on a trial of 142 adult patients with progressing desmoid tumors not amenable to surgery. The most common side effects were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection, and dyspnea. It received an orphan drug designation.
First-time generic drug approvals
Tofacitinib oral solution, 1 mg/mL, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. (Brand name: Xeljanz)
Spironolactone oral suspension, 25 mg/5 mL, for the treatment of class III to IV heart failure, as an add-on therapy for the treatment of hypertension, and for the management of edema in adult patients with cirrhosis who are not responding to fluid and sodium restrictions. (Brand name: CaroSpir)
Gadobutrol injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) imaging bulk package, for use with MRI to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system; to assess the presence and extent of malignant breast disease; to evaluate known or suspected supra-aortic or renal artery disease; and to assess myocardial perfusion (stress, rest) and late gadolinium enhancement (Brand name: Gadavist)
Fluorescein injection USP, 500-mg/5-mL (100-mg/mL) and 500-mg/2-mL (250-mg/mL) single-dose vials, indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature (Brand name: AK-FLOUR Injection)
Iopamidol injection USP, 41% single-dose vial, for angiography throughout the cardiovascular system; coronary arteriography and ventriculography; pediatric angiocardiography; selective visceral arteriography and aortography; peripheral venography; adult and pediatric IV excretory urography; and IV adult and pediatric contrast enhancement of computed tomographic head and body imaging (Brand name: Isovue-200 Injection)
Note: The FDA states that drugs are not always commercially available immediately after approval.