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Professional Birth & Postpartum Doula
Cindy lou Burgess C.D. & C.B.E.

Specializing in all birth options and covering all of Connecticut

Benefits of using a Doula
L&D drugs


Commonly used Obstetric Drugs
Many are not approved by the FDA

First, Do No Harm

Listed here are several commonly used drugs used in U.S. hospitals today. Many have not been approved by the FDA and have not undergone any or adequate testing to be used on laboring or lactating women or their neonates. It is wise not to be too cavalier about the common practice of "off-label" use. Administering some of these drugs is actually "anti-label". Fully informed consent should be obtained in writing.

Terbutaline
BRETHINE (terbutaline sulfate)
Mnfr: NOVARTIS PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 2150
Terbutaline sulfate has not been approved by the FDA and should not be used for tocolysis (to stop or slow contractions) and warns "Serious adverse reactions may occur after administration of terbutaline sulfate to women in labor". "Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration."
For more information from the manufacturer call or write:
Novartis Consumer Health, Inc.
560 Morris Avenue
Summit, NJ 07901
Direct inquiries to: (800) 635-2801

Toradol
TORADOL (ketorolac tromethamine)
Mnfr: ROCHE PHARMACEUTICALS
Not approved for pregnancy, labor, delivery or lactation.
The use of toradol is contraindicated in labor and delivery because through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
For more information from the manufacturer call or write:
Roche Pharmaceuticals
340 Kingsland Street
Nutley, NJ 07110
Direct inquiries to: (800) 526-6367

Duramorph
DURAMORPH (morphine sul. Inj.)
Mnfr: ELKINS-SINN, INC.
Not FDA approved for use in pregnancy, labor, delivery, or lactation.
Controlled clinical studies have shown that epidural administration has little of no effect on the relief of labor pain. Morphine produces a wide spectrum of pharmacologic effects, including analgesia, dysphoria, euphoria, somnolence, respiratory depression, diminished gastrointestinal motility Morphine administered intravenously, epidural and intrathecal readily passes into the fetal circulation and may result in respiratory depression in the neonate. Intravenous morphine may reduce the strength, duration and frequency of uterine contractions resulting in prolonged labor. The FDA approved label (package insert) for Duramorph specifies "Naloxone injection and resuscitative equipment should be immediately available for administration in case of life-threatening or intolerable side effects and whenever Duramorph therapy is being initiated." Patient monitoring should be continued for at least 24 hours after each dose since delayed respiratory depression may occur. Urinary retention: Urinary retention may persist 10 to 20 hours following administration of a single dose of Duramorph. Morphine is excreted in maternal milk. Effects on the nursing infant or the delayed long term development of the offspring exposed in utero to the drug are not known. Infumorph 200/500 is a preservative free morphine sulfate.
For more information from the manufacturer call or write:
Elkins-Sinn, Inc.
2 Esterbrook Lane
Cherry Hill, NJ 08003
Direct inquiries to: (800) 934-5556

Cytotec
CYTOTEC (misoprostol)
Mnfr: G.D. SEARLE & CO.
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2991
The Company warns that Cytotec should not be used by pregnant women. In 2000 the FDA and the manufacturer of Cytotec have issued warnings to health care providers that Cytotec is not approved by the FDA for the induction of labor and delivery or abortion. Under the heading of Labor and Delivery the package insert of Cytotec (misoprostol) warns: "Cytotec is not approved for the induction of labor and delivery or abortion. Cytotec is a synthetic analog of prostaglandin E1, and as such can induce or augment uterine contractions. Cytotec has been used outside of its (FDA) approved indication, as a cervical ripening agent for the induction of labor or abortion, in spite of specific contraindications to its use during pregnancy." Serious adverse events reported following off-label use of Cytotec for cervical ripening and/or induction of labor include maternal and fetal death; uterine hyperstimulation, perforation, or rupture requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy (excision of a uterine tube and ovary); amniotic fluid embolism; severe vaginal bleeding; retained placenta; shock; fetal bradycardia; and pelvic pain. There is an increased risk of uterine rupture when Cytotec is used in patients who have had prior Cesarean delivery or major uterine surgery.
For more information from the manufacturer call or write:
G.D. Searle & Co.
Chicago, Illinois 60680-5110
Direct inquiries to: (800) 323-1603

Fentanyl
ACTIQ (fentanyl citrate)
Mnfr: ANESTA CORP
Not FDA approved for pregnancy, labor, delivery or lactation.
Actiq is approved by the FDA only for the treatment of persistent cancer pain.
For more information from the manufacturer call or write:
Anesta Corp.
4745 Wiley Post Way
Salt Lake City, UT 84116

Dilaudid
DILAUDID (hydromorphone HCl)
Mnfr: KNOLL LABORATORIES
Not FDA approved for use in pregnancy, labor, delivery, or lactation.
Hydromorphone, a hydrogenated ketone of morphine, is a narcotic analgesic. It is believed to relate to the existence of opiate receptors in the central nervous system. Like morphine, adequate doses will relieve even the most severe pain. Nausea and vomiting occur infrequently. Dilaudid affects brain centers that control respiratory rhythm, and may produce irregular and periodic breathing. Limitations are imposed by the adverse effects of the drug resulting from high doses. Dilaudid is contraindicated in the presence of an intracranial lesion associated with increase intracranial pressure and when ever ventilatory function is depressed.
For more information from the manufacturer call or write:
Knoll Laboratories
3000 Continental Drive North
Mount Olive, New Jersey 07828-1234
Direct inquiries to: (800) 240-3820

Nubain
NUBAIN (nalbuphine hydrochloride)
Mnfr. Endo Pharmaceuticals
When used in labor and delivery, fetal bradycardia (with permanent neurological damage), RD at birth, apnea, cyanosis, hypotonia have been observed. Data suggests that Nubain is excreted in maternal milk. Caution should be exercised when Nubian is administered to a nursing woman.

Phenergan
PHENERGAN (promethazine hydrochloride)
Mnfr. Wyeth Laboratories
It is not known whether promethazine is excreted in human milk.
Caution should be exercised when promethazine is administered to a nursing woman.

Stadol
STADOL (butorphanol tartrate)
Mnfr. BRISTOL-MYERS SQUIBB COMPANY
Not FDA approved for pregnancy, labor, delivery or lactation.
Stadol is an analgesic, forty times more potent that Demerol. The analgesia provided by 2 mg of Stadol NS is equivalent to 10 mg of morphine, 40 mg pentazocine and 80 mg meperidine. When administered to the woman during labor the drug crosses the placenta and enters the blood, brain and other fetal organs within minutes. The central nervous system effects include depression of spontaneous respiratory activity and cough reflex, stimulation of the emetic center affecting nausea, and sedation. Other effects of Stadol include alterations in cardiovascular and lung function, and alterations in gastrointestinal, motor, and bladder sphincter activity. Stadol, like other mixed agonist-antagonists with a high affinity for the K-receptor, may produce unpleasant psychotic-like effects. Two mg of butorphanol IV and 10 mg of morphine sulfate IV depress respiration to a comparable degree. The label points out that 2 mg of butorphanol IV and 10 mg of morphine sulfate IV depressed respiration to the same degree in individuals without significant respiratory dysfunction. The duration of action of Stadol injection was 3-4 hours. The manufacturer advises the user that neurobehavioral testing of infants exposed to Stadol injection during labor showed no significant differences from infants in other drug treatment groups 18.6 hours after birth. The label does not mention the type of test used to evaluate the neurologic state of the infants. No information given as to how the infants in the Stadol group compared with infants that were not exposed to an epidural block.
For more information from the manufacturer call or write:
Bristol-Myers Squibb Company
345 Park Avenue
New York, New York 10154
Direct Inquiries to: (800) 468-7746

Vicodin
VICODIN (hydrocodone bitartrate and acetaminophen)
Mnfr: Knoll Laboratories
It is not known whether hydrocodone is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Vicodin a discussion should be made to discontinue nursing or discontinue the drug.

Morphine
ASTRAMORPH/PF (morphine sulfate inj.)
Mnfr: ASTRAZENECA LP
Not FDA approved for pregnancy, labor, delivery or lactation.
Astramorph/PF is a systemic narcotic analgesic for administration by intravenous, epidural or intrathecal routes. Please Note: Even though Astramorph/PF has NOT been approved by the FDA for use in obstetrics, the FDA has allowed the labeling to include the following paragraph: "Labor and Delivery: Intravenous morphine readily passes into the fetal circulation and may result in respiratory depression in the neonate. Naloxone and resuscitative equipment should be available for reversal of narcotic indeed respiratory depression the neonate. In addition, intravenous morphine may reduce the strength, duration and frequency of uterine contractions resulting in prolonged labor. Epidural and intrathecal administered morphine readily passes into the fetal circulation and may result in respiratory depression of the neonate. Controlled clinical studies have shown that epidural administration has little or no effect on the relief of labor pain. Close observation should be carried out for 24 hours following exposure".

For more information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800) 236-9933

Duramorph
DURAMORPH (morphine sul. Inj.)
Mnfr: ELKINS-SINN, INC.
Not FDA approved for use in pregnancy, labor, delivery, or lactation.
Controlled clinical studies have shown that epidural administration has little of no effect on the relief of labor pain. Morphine produces a wide spectrum of pharmacologic effects, including analgesia, dysphoria, euphoria, somnolence, respiratory depression, diminished gastrointestinal motility Morphine administered intravenously, epidural and intrathecal readily passes into the fetal circulation and may result in respiratory depression in the neonate. Intravenous morphine may reduce the strength, duration and frequency of uterine contractions resulting in prolonged labor. The FDA approved label (package insert) for Duramorph specifies "Naloxone injection and resuscitative equipment should be immediately available for administration in case of life-threatening or intolerable side effects and whenever Duramorph therapy is being initiated. Patient monitoring should be continued for at least 24 hours after each dose since delayed respiratory depression may occur. Urinary retention: Urinary retention may persist 10 to 20 hours following administration of a single dose of Duramorph. Morphine is excreted in maternal milk.
"
Effects on the nursing infant or the delayed long term development of the offspring exposed in utero to the drug are not known. Infumorph 200/500 is a preservative free morphine sulfate.
For more information from the manufacturer call or write:
Elkins-Sinn, Inc.
2 Esterbrook Lane



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