Is Bromazepam safe while breastfeeding?

Summary of use during breastfeeding

Bromazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Three partially breastfed infants were apparently not adversely affected by bromazepam in milk. However, the death of a newborn infant breastfed by a mother who was apparently using bromazepam was reported. If a mother of an older infant requires bromazepam, it is not a reason to discontinue breastfeeding; however, because of its relatively long half-life, an alternate drug is preferred, especially when nursing a newborn, preterm or sick infant.

Effects on the breastfed infant

A 4-week-old infant with a 5-day history of near-miss sudden infant death syndrome was brought to the emergency room with asystole and unresponsive pupils. Despite resuscitation, the infant died. The infant’s serum contained a plasma concentration of 0.38 mcg/mL of “diazepam equivalents” and the infant’s urine was positive for bromazepam. The mother appeared to have been taking sedatives over the last few days, while partially breastfeeding, because of nervousness and sleeplessness.[2] Bromazepam probably contributed to the infant’s death.[3]

Three infants whose mothers were taking bromazepam during pregnancy and postpartum in dosages of 1 or 2 mg three times daily were partially breastfed. No abnormalities were found at the 1-month and the 3-month checkups of any of the infants.[1]

Effects on milk supply

Relevant published information was not found as of the revision date.

Levels in milk

Maternal Levels. Three women who were partially breastfeeding their infants were taking bromazepam during pregnancy and postpartum in dosages of 1 or 2 mg three times daily. Random milk samples were obtained mostly in the first few days postpartum, but some samples were taken as long as the 40th day postpartum. Milk concentrations ranged from 4.2 to 53.4 mcg/L and single-point RID values ranged from 1.1 to 3.9%.

Infant Levels. Three infants whose mothers were taking bromazepam during pregnancy and postpartum in dosages of 1 or 2 mg three times daily were partially breastfed. In the first infant (maternal dose 1 mg 3 times daily), serum concentrations of 44.5 and 48.8 mcg/L in the first day postpartum probably represent placental transfer. In the second infant (maternal dose 2 mg 3 times daily), a level of 54.8 mcg/L in the first 0.1 day postpartum probably also represents placental passage. A second sample of 43.9 mcg/L taken 2.6 days postpartum at 65.2 hours after the mother’s last dose may reflect both transplacental and breastmilk passage. Three serum samples of 2.1. 3.1, and 16.1 mcg/L on the 40th day postpartum may reflect breastmilk passage better than other reported values among these three infants. In the third infant (maternal dose 2 mg 3 times daily), serum concentrations of 13 to 32.7 mcg/L between days 3 and 5 postpartum might reflect both transplacental and breastmilk passage.[1]

Alternatives LactMed lists

• Oxazepam
• Temazepam