Which herbal substance is considered an opioid by the FDA? What is the first blood test approved to aid in the diagnosis of concussion? Scroll through the slides for questions and answers in this FDA quiz.
Discussion: Kratom (Mitragyna speciose) is sometimes used to treat symptoms of opioid withdrawal. In February, 2018, FDA commissioner Scott Gottlieb, MD, issued a statement about the FDA’s recent scientific analysis, providing strong evidence that kratom contains opioid compounds and highlighting its potential for abuse and dependence. The statement said that “no reliable evidence” supports the use of kratom for treating opioid use disorder, and emphasized significant safety issues associated with the supplement, including seizures and respiratory depression. To date, 44 reported deaths have been associated with kratom. The FDA also issued a public health advisory warning consumers not to take kratom.
Discussion: In February 2018, the FDA approved the Brain Trauma Indicator (Banyon Biomarkers Inc), the first blood test designed to evaluate blood biomarkers for mild traumatic brain injury, or concussion, in adults. The test measures blood levels of two proteins, ubiquitin C-terminal hydrolase and glial fibrillary acidic protein, that are released into the blood and can be measured within 12 hours of traumatic brain injury. The test may help doctors determine which patients need CT scans, and which can be spared unnecessary radiation exposure.
Discussion: The FDA recently issued a safety communication advising caution with the use of clarithromycin in patients with heart disease, because of increased risk of heart problems and death. This warning was added to the label of the antibiotic, and it urges providers to consider other antibiotics in patients with heart disease. The warning follows release of 10-year follow-up results from the CLARICOR clinical trial showing an unexpected spike in mortality among patients with coronary heart disease after a 2-week course of clarithromycin.
Discussion: In February 2018, Embrace (Empatica Inc) became the first smart watch to receive FDA clearance for tracking seizures in epilepsy. The device uses advanced machine learning, monitors electrodermal activity to measure the “fight-or-flight” response, and sends alerts to caregivers when help is needed. In a clinical trial involving 135 inpatients continuously monitored for seizure activity over 272 days, Embrace detected 100% of seizures. Embrace has been approved in Europe for seizure monitoring since 2017.