This commentary outlines the current drug labeling practices that potentially compromise the clinical care of pregnant women and their children. We highlight the need for drug manufacturers and lawmakers to change the status quo and consider practices and regulations that will provide much-needed guidance to clinicians on the safe administration of drugs to certain populations such as pregnant and nursing women. Current practices have de facto contributed to a situation in which evidence is inadequate for individual physicians and patients to weigh the risks and benefits of drug administration and make informed decisions for drug use during pregnancy and lactation.
“I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone”
We are 2 academic obstetric anesthesiologists who practice, teach, and research obstetric anesthesiology. Our professional goals include determining which labor analgesia and cesarean delivery anesthesia and analgesic regimens are for the good of our patients (which we define as regimens that are effective and safe in our daily clinical practice) and teaching these regimens (which include specific combinations of technique[s] and drug[s]) to trainees. Stated differently, our goal is to practice cutting-edge, evidenced-based obstetric anesthesia.
Our general clinical practice involves performing epidural or combined spinal epidural labor analgesia, administering neuraxial or general anesthesia for cesarean delivery, and providing effective post–cesarean delivery analgesia. We also routinely participate in the care of high-risk obstetric patients or those with complications of labor and delivery (eg, postpartum hemorrhage).
The anesthetic techniques and routine clinical care of the parturient require the administration of a number of drugs ( Table 1 ). These drugs, approved for use in the United States by the Food and Drug Administration (FDA), have been administered to thousands of our patients. If we speculate that most anesthesiologists in the United States follow similar anesthetic practices, then millions of women and their fetuses/neonates have been exposed to these drugs. We routinely use these drugs in this patient population because according to (our) judgment and (our) ability, we are prescribing them for the good of (our) patients.
| Drug | Pregnancy use | Obstetric setting | Indication for use |
|---|---|---|---|
| Propofol | Category B a | Cesarean delivery | Induction of general anesthesia |
| Etomidate | Category C b | Cesarean delivery | Induction of general anesthesia |
| Ketamine | Category B a | Cesarean delivery | Induction of general anesthesia analgesia |
| Midazolam | Category D c | Peripartum | Anxiolysis |
| Succinylcholine | Category C b | Cesarean delivery | Skeletal muscle relaxation |
| Rocuronium | Category C b | Cesarean delivery | Skeletal muscle relaxation |
| Ephedrine | Category C b | Peripartum | Treatment of hypotension |
| Phenylephrine | Category C b | Peripartum | Treatment of hypotension |
| Ondansetron | Category B a | Peripartum | Treatment of nausea and vomiting |
| Metoclopramide | Category B a | Peripartum | Treatment of nausea and vomiting |
| Ranitidine | Category B a | Peripartum | Decrease gastric volume and pH |
| Sodium citrate | Category C b | Cesarean delivery | Decrease gastric pH |
| Cefazolin | Category B a | Cesarean delivery | Antibiotic prophylaxis |
| Nitroglycerin | Category C b | Peripartum | Treatment of uterine tachysystole |
| Bupivacaine | Category C b | Labor and cesarean delivery | Neuraxial (epidural and intrathecal) analgesia and/or anesthesia |
| Ropivacaine | Category B a | Labor and cesarean delivery | Neuraxial analgesia and/or anesthesia |
| Lidocaine | Category B a | Labor and cesarean delivery | Neuraxial analgesia and/or anesthesia |
| Fentanyl | Category C b | Labor and cesarean delivery | Neuraxial and/or intravenous analgesia |
| Sufentanil | Category C b | Labor and cesarean delivery | Neuraxial and/or intravenous analgesia |
| Remifentanil | Category C b | Labor and cesarean delivery | Intravenous analgesia |
| Morphine | Category C b | Cesarean delivery | Neuraxial and/or intravenous analgesia |
| Hydromorphone | Category C b | Cesarean delivery | Neuraxial and/or intravenous analgesia |
| Oxycodone | Category B a | Peripartum | Analgesia |
| Acetaminophen | Category B a | Peripartum | Analgesia |
| Ibuprofen | Category C b | Postpartum | Analgesia |
| Ketorolac | Category C b | Postpartum | Analgesia |
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