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Class ⬇

Antidote (Cholinesterase Reactivator)

PREGNANCY RECOMMENDATION:Limited Human Data—No Relevant Animal Data (Maternal Benefit May Outweigh Any Potential Embryofetal Risk)

BREASTFEEDING RECOMMENDATION:Potential Toxicity (Hold Breastfeeding)

Pregnancy Summary ⬆ ⬇

Two reports describing the use of pralidoxime in three human pregnancies have been located. Exposures occurred during the second and third trimesters in treating organophosphate poisoning. Three healthy infants were born. The drug will probably cross the placenta, so some fetal exposure will likely occur. Therefore, the absence of human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal reproduction studies have not been conducted. Using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure. Given the indication for use, the maternal benefit clearly outweighs any concern regarding embryofetal toxicity.

Breastfeeding Summary ⬆ ⬇

No reports describing the use of pralidoxime during human lactation have been located. The drug will likely be excreted into human breast milk, so some infant exposure will probably occur. The emergency nature of pralidoxime use suggests that nursing is unlikely when it might be indicated. However, the maternal benefit is clear, and breastfeeding can be held for about 6 to 7 hours (about five half-lives) after a dose is administered. If the clinical decision is to use this drug while breastfeeding, the infant should be monitored for the most common reported adult side effects of dizziness, headache, nausea, and blurred vision (all leading to irritability), tachycardia, increased blood pressure, hyperventilation, and lethargy.

Reference ⬆

  1. Prescribing Information. Protopam chloride. Baxter Healthcare Corporation; 2018.
  2. KarallieddeL, SenanayakeN, AriaratnamA. Acute organophosphorus insecticide poisoning during pregnancy. Hum Toxicol . 1988;7:363-364.
  3. KamhaAA, Al OmaryIYM, ZalabanyHA, et al. Organophosphate poisoning in pregnancy: a case report. Basic Clin Pharmacol Toxicol . 2005;96:397-398.