Accidental Flibanserin Ingestion in Children Causing Acute Respiratory and Central Nervous System Depression: What Health Care Professionals Need to Know.

This commentary serves to raise awareness for health care professionals about the potential risks of accidental ingestion of flibanserin tablets by children. Flibanserin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of acquired generalized hypoactive sexual desire disorder in premenopausal women. Since its approval in 2015, the FDA has identified five reports of serious accidental ingestion by toddlers. All five children, boys with ages ranging from 18 months to 2 years, presented with central nervous system and respiratory depression, and two of them required intubation. A combination of hypertension, hyperthermia, and seizure-like activity was also seen in four of the five children. The clinical manifestation resembles serotonin syndrome (eg, tachycardia, hypertension, and muscle stiffness). As flibanserin use increases, greater awareness by health care professionals regarding the risk of accidental pediatric ingestion is needed to facilitate preventative counseling for patients with young children.

Domperidone for Lactation: What Health Care Providers Need to Know.

This commentary serves to raise health care provider awareness about the regulatory status and available evidence regarding domperidone for insufficient lactation. Breastfeeding provides significant health benefits for mothers and infants, and insufficient milk production remains the most common reason for early weaning. Domperidone, a dopamine receptor antagonist that may increase milk production, is not approved for any human use in the United States. It is approved in some countries for certain gastrointestinal disorders, but is not approved in any country for lactation enhancement. Domperidone is associated with serious cardiac arrhythmias. The U.S. Food and Drug Administration (FDA) issued an import alert in 2004, updated in 2012, explaining that the importation of domperidone is illegal with limited exceptions, including when imported pursuant to an investigational new drug application. The FDA also issued a public safety warning regarding the use of domperidone for lactation. Nonetheless, domperidone is sometimes being obtained illegally and used in attempts to increase milk production in lactating mothers. There is limited quality evidence for the effectiveness of domperidone for lactation enhancement. In contrast, considerable information exists on domperidone's cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death, including among lactating women. In light of limited efficacy data that do not offset safety concerns from a public health perspective, we continue to caution against using domperidone for lactation enhancement. Research and drug development are needed to address the significant unmet medical need for lactation disorders.