SUMMARIES OF "DEAR HEALTH PROFESSIONAL"
LETTERS AND OTHER SAFETY NOTIFICATIONS

Reusable Devices -- FDA's Center for Devices and Radiological Health warns of a potential infection problem with medical devices that are rented or leased by health care facilities. Recommendations are provided to help ensure that reusable (nondisposable) medical devices rented or leased from third parties are properly cleaned, disinfected, and/or sterilized. [April 17, 1997 (letter) - FDA]

Sucostrin (succinylcholine) -- Bristol-Myers Squibb calls attention to two life-threatening events that may occur with the use of succinylcholine: (1) Cardiac Arrest in Children and Adolescents Receiving Succinylcholine - There have been several reports of cardiac arrest following administration of succinylcholine to apparently healthy children and adolescents who were subsequently found to have undiagnosed myopathies. Because children and adolescents are more likely than adults to have such undiagnosed myopathies, a non-depolarizing neuromuscular blocking drug should be used for routine elective surgery in these patients; and (2) Succinylcholine-induced Hyperkalemia - Except when used for emergency tracheal intubation or in instances where immediate securing of the airway is necessary, succinylcholine is contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury because administration to such individuals may result in severe hyperkalemia, which may lead to cardiac arrest. The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk depends on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known. [April 3, 1997 (letter) - Apothecon]

Lamictal - New warnings in the labeling for the antiepileptic lamotrigine (Lamictal) pertain to reports of severe, potentially life-threatening rash, including Stevens-Johnson syndrome, and, rarely, toxic epidermal necrolysis, reported in association with the use of lamotrigine. A boxed warning emphasizes that lamotrigine is not indicated for use in patients below the age of 16 years. Reports from clinical trials suggest that as many as 1 in 100 to 1 in 50 pediatric patients treated with lamotrigine develop a potentially life-threatening rash, as compared with approximately 1 in 1,000 adults. Before receiving lamotrigine, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. [March 1997 (letter) - Glaxo Wellcome, Inc.]

Devices for Direct Detection of Group B Streptococcal Antigen - FDA alerts health professionals of potentially fatal misdiagnoses when using test kits to detect group B streptococcal (GBS) antigen and provides guidelines on how to use these tests appropriately. Antigen tests for GBS have produced false negative results from specimens from pregnant women and infants who subsequently died from GBS disease. These tests have also produced false positive results that may lead to inappropriate antibiotic therapy and prolonged hospitalization. Clinicians need to understand the limitations of these devices. Antigen tests are an adjunct to diagnosis and are NOT an appropriate substitute for properly performed bacterial culture in the diagnosis of GBS. [March 24, 1997 (safety alert) - FDA]

Infant Formula (Homemade) - There may be serious safety concerns about the use of a homemade infant formula based on a recipe from two doctors in Shippensburg, PA. Prolonged use of the formula, particularly if it is the sole source of nutrition, could be hazardous to the health of an infant. Among the concerns are hypochloremia, hypokalemia, hypermanganesmemia, metabolic acidosis, vitamin deficiencies, and failure to thrive. [February 26, 1997 (letter) - FDA]

Gamma Acid (GHB) - FDA reissues its warning against the use of GHB, a chemical that has been promoted as a steroid alternative for bodybuilding and other uses for several years. Recently it has gained favor as a recreational drug because of its intoxicating effects. Numerous cases of GHB-related illness have been reported. Symptoms include vomiting, dizziness, tremors, and seizures. Many of those injured required hospitalization, and some deaths have been linked to the use of GHB. GHB is NOT approved for sale as a medical product in the United States. [February 18, 1997 (talk paper) - FDA]

FDA/Website Management Staff