Recalls and alerts
A class I recall of the Cortrak*2 Enteral Access System by Avanos Medical due to the risk of misplaced enteral tubes causing patient harm. There have been 60 injuries and 23 patient deaths related to misplaced tubes while using the system since 2015. Adverse events reported include respiratory failure, pneumothorax, perforation, pneumonia, and pleural effusion. The recall includes 629 devices distributed from April 1, 2016, to Jan. 1, 2022.
A class I recall of the Dragonfly OpStar Imaging Catheter by Abbott Medical because the proximal marker band may become loose and separate from the catheter during use. There have been five incidents, one injury, and no deaths related to this issue. The recall includes 4,800 devices.
A class I recall of the iCast Covered Stent System by Atrium Medical Corporation due to the potential for balloon or catheter hub separation that may cause patient harm. There have been 75 complaints, nine injuries, and no deaths related to this issue. The recall includes 68,812 devices distributed from Dec. 31, 2018, through March 31, 2022.
A class I recall of the Sara Plus floor lift by ArjoHuntleigh Polska due to risk of smoke or fire when the lift is used with a depleted battery. There have been 44 complaints, no injuries, and no deaths related to this issue. The recall includes 1,929 devices and spare parts intended for use in hospitals, nursing homes, and other health care facilities.
Amended emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines for the prevention of COVID-19 in children as young as age 6 months. The FDA determined that the known and potential benefits of the vaccines outweigh the known and potential risks in the pediatric populations authorized for their use. For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of the vaccine in individuals ages 6 months through 4 years. The vaccine had been authorized for use in individuals ages 5 years and older. For the Moderna vaccine, the FDA amended the EUA to include use of the vaccine in individuals ages 6 months through 17 years. The vaccine had been authorized for use in adults ages 18 years and older.
A class I recall of the Accula SARS-CoV-2 Test by Mesa Biotech because certain lots have increased risk for false-positive results due to contamination at the manufacturing facility. The recall includes 6,177 tests distributed from Jan. 19 to Feb. 8, 2022.
EUA of the first COVID-19 test available without a prescription that also detects influenza and respiratory syncytial virus. The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test allows an individual to self-collect a nasal swab sample at home and send it to Labcorp for testing for influenza A and B, respiratory syncytial virus, and SARS-CoV-2. Results are delivered through an online portal, with follow-up from a clinician for positive or invalid test results.
An amended EUA for the Pfizer-BioNTech COVID-19 Vaccine. A single booster dose is now authorized for administration to individuals ages 5 through 11 years at least five months after completion of a primary series with the vaccine.
Tirzepatide injection (Mounjaro) to improve blood glucose control in adults with type 2 diabetes, as an addition to diet and exercise. The first-in-class medicine, which activates the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, is administered subcutaneously once weekly, with the dose adjusted as tolerated to meet blood glucose goals. Three different doses (5 mg, 10 mg, and 15 mg) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines. Side effects include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. The drug is not indicated for use in type 1 diabetes and has not been studied in those with a history of pancreatitis. It causes thyroid C-cell tumors in rats; it is unknown whether it causes such tumors, including medullary thyroid cancer, in humans.
A new indication for dupilumab (Dupixent) to treat eosinophilic esophagitis in adults and pediatric patients ages 12 years and older who weigh at least 40 kg. The drug is the first FDA-approved treatment for patients with eosinophilic esophagitis. It was originally approved in 2017 to treat moderate-to-severe atopic dermatitis in adult and pediatric patients ages 6 years and older whose disease is not adequately controlled by topical prescription therapies or when those therapies are not advisable. Efficacy and safety of the drug in treating eosinophilic esophagitis were studied in a randomized controlled trial, which included two 24-week treatment periods. The most common side effects associated with the drug include injection-site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. The drug label carries warnings and precautions, including those addressing potential development of allergic reactions, conjunctivitis, keratitis, or joint pain; use in patients with certain parasitic infections; and use in conjunction with live vaccinations.
Note: The FDA states that drugs are not always commercially available immediately after approval.