Is droperidol safe in pregnancy

From the Guidelines

Droperidol is not safe in pregnancy.

Safety Concerns

• The provided evidence does not specifically address the safety of droperidol in pregnancy, but it does highlight several safety concerns, including hypotension, prolongation of the QTc interval, and extrapyramidal signs 1.
• These side effects are significant and could potentially harm both the mother and the fetus.
• Additionally, the FDA has added a black-box warning to the product label, indicating that droperidol should be used only when first-line drugs are unsuccessful, due to the potential for sudden cardiac death at high doses 1.

Pregnancy Considerations

• In the context of real-life clinical medicine, it is generally recommended to err on the side of caution when it comes to medication use in pregnancy.
• Without specific evidence supporting the safety of droperidol in pregnancy, it is best to avoid its use in pregnant women.
• Instead, alternative sedation options should be considered, and the risks and benefits of each option should be carefully weighed on a case-by-case basis.

From the FDA Drug Label

Droperidol administered intravenously has been shown to cause a slight increase in mortality of the newborn rat at 4.4 times the upper human dose. At 44 times the upper human dose, mortality rate was comparable to that for control animals. Following intramuscular administration, increased mortality of the offspring at 1. 8 times the upper human dose is attributed to CNS depression in the dams who neglected to remove placentae from their offspring. Droperidol has not been shown to be teratogenic in animals. There are no adequate and well-controlled studies in pregnant women. Droperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

The safety of droperidol in pregnancy is not established due to lack of adequate and well-controlled studies in pregnant women. Potential risk to the fetus exists, and droperidol should only be used during pregnancy if the potential benefit justifies the potential risk 2. Key considerations include:

• Increased mortality of newborn rats at high doses
• No evidence of teratogenicity in animals
• Insufficient human data to support safe use in pregnancy

From the Research

Safety of Droperidol in Pregnancy

• The safety of droperidol in pregnancy is a topic of discussion, with some studies suggesting that it may be effective but with insufficient safety data to recommend it as a first-line agent 3.
• A study from 1991 found that droperidol was effective as a prophylactic anti-emetic in day case termination of pregnancy, with no significant difference in efficacy between doses of 2.5 mg, 1.25 mg, and 0.25 mg 4.
• Another study from 1998 investigated the use of droperidol to alleviate side effects of epidural morphine after cesarean section, and found that i.v. droperidol reduced the incidence and severity of nausea and vomiting, but did not prevent itching 5.
• A more recent review from 2023 suggests that droperidol is effective and safe, despite a boxed warning issued by the FDA, and can be used as a sedative, anxiolytic, analgesic, and antiemetic medication in various clinical indications, including in patients who are opioid-tolerant 6.
• A study from 1987 found that low dose droperidol (0.25 and 0.5 mg) was effective in reducing postoperative nausea and vomiting after prostaglandin administration for day case termination of pregnancy, without delaying immediate recovery or discharge home 7.

Efficacy of Droperidol as an Antiemetic

• Droperidol has been found to be effective in reducing nausea and vomiting in various clinical settings, including after cesarean section 5 and after prostaglandin administration for day case termination of pregnancy 4, 7.
• A review from 2023 suggests that droperidol has equal or greater efficacy in reducing nausea and vomiting than ondansetron and metoclopramide, with similar adverse effects 6.

Use of Droperidol in Pregnancy-Related Procedures

• Droperidol has been used as a prophylactic anti-emetic in day case termination of pregnancy, and has been found to be effective in reducing nausea and vomiting 4, 7.
• The medication has also been used to alleviate side effects of epidural morphine after cesarean section, with i.v. droperidol reducing the incidence and severity of nausea and vomiting 5.