Recalls and alerts
A recall of one lot of midazolam injection USP (2 mg/2 mL packaged in 2-mL prefilled single-use glass syringes) by Fresenius Kabi USA due to mislabeling. Instead of midazolam, the syringes contain and are labeled as ondansetron injection USP (4 mg/2 mL).
An alert regarding an increase in reports of the occurrence of Type III endoleaks with the use of endovascular graft systems indicated for endovascular aneurysm repair. The FDA encourages continued reporting of endoleak events and is investigating the prevalence and contributing factors of the issue, as well as the risks and benefits of secondary interventions.
The Magnetom Terra, the first seven tesla (7T) MRI device cleared for clinical use in the U.S. Before the approval, the country's clinical MRI systems were available in field strengths of 3T and below. The FDA cleared the device after comparing it to a predicate device, obtaining sample clinical images, and reviewing manufacturer data. Radiologists who reviewed the data, which compared images of 35 healthy patients that were taken by the 7T device versus the 3T device, confirmed that the images taken by the 7T device were of diagnostic quality and were, in some cases, an improvement over the 3T images. The device is indicated for patients weighing more than 66 pounds and is limited to examinations of the head and extremities.
The Remedē System, an implantable device to treat patients with moderate to severe central sleep apnea. The device consists of a battery pack surgically placed under the skin of the upper chest and small, thin wires inserted in the chest near the phrenic nerve. During sleep, the system monitors respiratory signals and stimulates the nerve to move the diaphragm and restore normal breathing. The FDA reviewed data from 141 patients that showed that after six months, apnea hypopnea index (a measure of the frequency and severity of apnea episodes) was reduced by 50% or more in 51% of patients with the system, compared to 11% of patients without it. The most common adverse events were concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The device is contraindicated in patients with an active infection and those who require MRI. It is not indicated for patients with obstructive sleep apnea.
Abemaciclib (Verzenio) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The drug is approved to be administered in combination with fulvestrant in patients whose cancer grew on endocrine therapy or on its own in patients previously treated with endocrine therapy and chemotherapy after cancer metastasized. The combination treatment was studied in a randomized trial of 669 patients, where the median progression-free survival on combination therapy was 16.4 months compared to 9.3 months among patients taking placebo with fulvestrant. A single-arm trial tested the drug as a standalone treatment and found that 19.7% of 132 patients experienced complete or partial shrinkage of their tumors for a median 8.6 months. Common side effects include diarrhea, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache. Serious side effects include diarrhea, neutropenia, elevated liver blood tests, deep venous thrombosis, and pulmonary embolism.
The FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adults to make diabetes treatment decisions without blood sample calibration from a fingerstick. The system uses a small sensor wire inserted below the skin to continuously measure and monitor glucose levels. Patients can determine glucose levels by waving a dedicated, mobile reader above the sensor wire. After a 12-hour start-up period, the device can be worn for up to 10 days. Approval was based on a study that compared its readings to those obtained by an established laboratory method. Risks include hypoglycemia or hyperglycemia in cases where inaccurate information is provided by the device, as well as mild skin irritation around the insertion site. The device does not provide real-time alerts or alarms unless the user initiates an action. For example, it will not alert users to low blood glucose levels while they are asleep.
Axicabtagene ciloleucel (Yescarta) to treat adults with certain types of large B-cell lymphoma who have not responded to or have relapsed after at least two other kinds of treatment. In a multicenter trial of more than 100 adults, the complete remission rate after treatment with the cell-based gene therapy was 51%. The drug carries a boxed warning about cytokine release syndrome and neurologic toxicities, which can be fatal or life-threatening. Other side effects include serious infections, low blood cell counts, and a weakened immune system. The orphan drug was approved with a risk evaluation and mitigation strategy, and hospitals and their associated clinics must be specially certified to dispense it.
First-time generic approvals
Glatiramer acetate injection (40 mg/mL) to reduce the frequency of relapses in certain patients with relapsing-remitting multiple sclerosis. (Brand name: Copaxone)
Note: The FDA states that drugs are not always commercially available immediately after approval.