Alliance for the Improvement of Maternity Services (AIMS)

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ACTIQ (fentanyl citrate)
Mnfr: ANESTA CORP
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 556
Actiq is approved by the FDA only for the treatment of persistent cancer pain. See package insert for Black Box warning. For more information from the manufacturer call or write:
Anesta Corp.
4745 Wiley Post Way
Salt Lake City, UT 84116
Direct inquiries to: (801) 595-1405

ACULAR (ketorolac tromethaline)
Mnfr: ALLERGAN, INC.
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 510
Ophthalmic solution administered to relieve itching of the eyes For more information from the manufacturer call or write:
Allergen, Inc.
2525 Dupont Drive
Irvine, CA 92623
Direct Inquiries to: (714) 246-4500

ALFENTANIL HCl (Alfentanil HCl)
Mnfr: BAXTER PHARM. PRODUCTS
Not FDA approved for pregnancy, labor, delivery or lactation. ALL INFORMATION HAS BEEN OMITTED FROM THE PDR.
For information from the manufacturer call or write:
Baxter Pharmaceutical Prod. Inc.
96 Spring St.
New Providence, NJ 07974
Direct inquiries to: (800) 262-3784

AMINO-CERV CREME (amino-Acid/Urea)
Mnfr: MILEX PRODUCTS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2063
For cervical treatment for mild cervicitis, postpartum cervicitis, postpartum cervical tears, post surgical cervical procedures and to aid in the dissolving of dead or burned tissue. The Indications section of this drug does not mention its use during lactation.
For more information from the manufacturer call or write:
Milex Products, Inc.
4311 No. Normandy
Chicago, Ill. 60634
Direct Inquiries to: (800) 621-1278

ANECTINE (succinylcholine chloride)
Mnfr: GLAXO WELLCOME
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 1352
Succinylcholine is commonly used to provide muscle relaxation during delivery by cesarean section. A skeletal muscle relaxant for intravenous administration, and mechanical ventilation. FDA labeling carries warning regarding the risk of cardiac arrest from hyperkalemic rhabdomyolysis.
For more information from the manufacturer call or write:
Glaxo Wellcome Inc.
Five Moore Drive
Research Triangle Park, NC 27709
Direct inquiries to: (800) 334-0089

ASTRAMORPH/PF (morphine sulfate inj.)
Mnfr: ASTRAZENECA LP
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 563
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

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".
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

BREVIBLOC INJECT (esmolol HCl)
Mnfr: BAXTER PHARM.PROD. INC.
Not FDA approved for pregnancy, labor, delivery or lactation.PDR PG 822
"There are no adequate and well-controlled studies in pregnant women. Use of esmolol in the last trimester of pregnancy or during labor and or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. Brevibloc should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus".
For more information from the manufacturer call or write:
Baxter Pharmaceutical Prod. Inc.
96 Spring St.
New Providence, N.J.07974
Direct inquiries to: (800) 262-3784

CATAPRES-TTS (clonidine hcl)
Mnfr: BOEHRINGER INGELHEIM
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 968
Clonidine stimulates alpha-adrenoreceptors in the brain stem. Clonidine is indicated in the treatment of hypertension, but not in pregnancy. The package insert cautions, "No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed"
For more information from the manufacturer call or write:
Boehringer Ingelheim Pharm. Inc
900 Ridgebury Road/P.O. Box 368
Ridgefield, CT 06877
Direct inquiries to: (800) 542-6257

COMPAZINE (prochlorperazine)
Mnfr: SMITHKLINE BEECHAM
Not FDA approved for use in pregnancy, labor, delivery or lactation. PDR pg. 3077
Safety for the use of compazine during pregnancy has not been established. Therefore Compazine is not recommended for use in pregnant patients except in cases of severe nausea and vomiting that are so serious and intractable that in the judgement of the physician, drug intervention is required and (the) potential benefits outweigh (the) possible hazards." Hazards include prolonged jaundice, extrapyramidal signs (loss of neurologic control of speech and hands), hyperflexia, or hyporeflexia in newborn infants whose mothers received the drug. The package insert mentions that there are fetal risks involved in the use of Compazine but does not define those risks.
For more information from the manufacturer call or write:
SmithKline Beecham Pharmaceuticals
One Franklin Plaza
Philadelphia, PA 19101
Direct inquiries to:(800) 355-8900 ext. 5231

CORTROSYN (cosyntropin)
Mnfr. ORGANON INC.
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 2259
Administered to screen for adrenal cortical insufficiency and administered off-label for treatment of postdural headache. For more information from the manufacturer call or write:
Organon Inc.
375 Mt. Pleasant Ave.
West Orange, NJ 07052
Direct Inquiries to: (972) 325-4500

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

DECADRON (dexamethasone)
Mnfr. MERCK
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 1914
For information from the manufacturer call or write:
Merck & Co., Inc.
West Point, PA 19486
Direct inquiries to: (800) 672-6372

DILANTIN (phenytoin)
Mnfr: PARKE-DAVIS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2425
Phenytoin is an antiepileptic drug that helps in the control of seizures. The reports suggesting a higher incidence of birth defect in children of drug treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. The great majority of mothers on antiepileptic medication delivery apparently normal infants. In addition to the reports of increased incidence of congenital malformations, such as cleft lip/palate and heart malformation in children of women receiving phenytoin and other antiepileptic drugs, there have more recently been reports of a fetal hydantoin syndrome.
For more information from the manufacturer call or write:
Parke-Davis
201 Tabor Road
Morris Plains, NJ 07950
Direct inquiries to: (800) 223-0432

DILAUDID (hydromorphone HCl)
Mnfr: KNOLL LABORATORIES
Not FDA approved for use in pregnancy, labor, delivery, or lactation. PDR pg. 1618
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

DIPRIVAN 1% (propofol)
Mnfr. ASTRAZENECA LP
Not FDA approved for pregnancy, labor, delivery or lactation PDR pg. 620
Diprivan is an IV sedative-hypnotic agent for both induction and maintenance of anesthesia for surgery. FDA specifically recommends against the use of the drug for obstetrics, including cesarean section deliveries.
For more information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800) 236-9933

DURAGESIC (fentanyl transdermal system)
Mnfr. JANSSEN PHARM.PROD.
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 1573
Duragesic is not recommended for analgesia during labor and delivery.
For more information from the manufacturer call or write:
Janssen Pharmaceutica Products, L. P.
1125 Trenton-Harbourton Rd.
Titusville, NJ 08560
Direct inquiries to: (800) 526-7736

DURAMORPH (morphine sul. Inj.)
Mnfr: ELKINS-SINN, INC.
Not FDA approved for use in pregnancy, labor, delivery, or lactation. PDR pg. 1195
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

DURANEST (etidocaine)
Mnfr. ASTRAZENECA
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 566
Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity.
For more information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800) 236-9933

FLUOTHANE (halothane)
Mnfr: WYETH-AYERST PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 3374
Fluothane is an inhalation anesthetic. Induction and recovery are rapid and depth of anesthesia can be readily altered. The drug progressively depresses respiration. Pharyngeal and laryngeal reflexes are rapidly blunted. It causes bronchodilation. Hypoxia, acidosis, or apnea may develop during deep anesthesia. Fluothane increases cerebrospinal-fluid pressure. Fluothane is not recommended for obstetric anesthesia except when uterine relaxation is required. The uterine relaxation obtained with Fluothane, unless carefully controlled, may fail to respond to ergot derivatives and oxytocic drugs. It is not known whether this drug is excreted in breast milk. Among the adverse reactions listed by the manufacturer of Fluothane are mild, moderate, and severe hepatic dysfunction (including hepatic necrosis); cardiac arrest; hypotension; respiratory arrest; cardiac arrhythmias; hyperpyrexia; shivering; nausea; and emesis. Some studies have show Fluothane to be teratogenic, embryotoxic, and fetotoxic in the mouse, rat, hamster and rabbit at subanesthetic and/or anesthetic concentrations. There are no adequate and well-controlled studies in pregnant women. Fluothane should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
For more information from the manufacturer call or write:
Wyatt-Ayerst Pharmaceuticals
Division of American Home Products Corporation
P.O. Box 8299
Philadelphia, PA 19101
Direct inquiries to: (610) 688-4400

FORANE (isoflurane)
Mnfr. BAXTER PHARM.PRODUCTS
ALL INFORMATION HAS BEEN OMITTED FROM THE PDR. Not FDA approved for pregnancy, labor, delivery or lactation.
For information from the manufacturer call or write:
Baxter Pharmaceutical Prod. Inc.
96 Spring St.
New Providence, NJ 07974
Direct inquiries to: (800) 262-3784

GLUCOVANCE (Glyburide)
Mnfr. BRISTOL-MYERS SQUIBB
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 3477
Used to improve glycemic control in patients with Type II diabetes. There are no adequate and well controlled studies in pregnant women with glucovance or its individual components.
For more information from the manufacturer call or write:
Bristol-Myers Squibb
P.O. Box 4500
Princeton, NJ 08543
For Medical information : (800) 321-1335
Adverse drug reporting: (609) 818 3737

HEPARIN Sodium
Mnfr. WYETH-AYERST
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 3376
Anticoagulant therapy and prophylaxis for venus thrombosis. It is not known whether Heparin Sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal and human reproduction studies have not been conducted with Heparin Sodium.
For more information from the manufacturer call or write:
Wyatt-Ayerst Pharmaceuticals
Division of American Home Products Corporation
P.O. Box 8299
Philadelphia, PA 19101
Tel: (610) 688-4400
Direct inquiries to: (800) 934-5556

LOVENOX (enoxaparin sodium)
AVENTIS PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 713.
For the prevention of deep vein thrombosis which may lead to pulmonary embolism. There are no adequate and well controlled studies in pregnant women. There have been a few spontaneous fetal deaths when pregnant women received enoxaparin.
For more information from the manufacturer call or write:
Aventis Pharmaceuticals
399 Interpace Parkway
P.O. Box 663
Parsippany, NJ 07054
Direct inquiries to: (800)663-1610

MEPERGAN (meperidine HCl/prometh HCl)
Mnfr: WYETH-AYERST PHAR
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 3403
Mepergan is a combination of meperidine HCl and promethazine HCl. Meperidine HCl is a narcotic analgesic with multiple actions similar to those of morphine. When used as an obstetrical analgesic Meperidine crosses the placental "barrier" and can produce respiratory depression in the newborn: resuscitation may be required. Among the major hazards of meperidine are respiratory depression, circulatory depression, respiratory arrest, shock and cardiac arrest. Affect on the Central Nervous System includes Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movement, transient hallucination and disorientation, visual disturbance and rarely, an extrapyramidal reaction (the loss of neurologic control of speech and hand movements). Phenergan promethazine HCl is a phenothiazine derivative that has several properties including antihistaminic, sedative and antiemetic actions Mepergan, like all pain relieving drugs has the potential to elevate cerebrospinal-fluid pressure, which can be exaggerated in the presence of intracranial pressure. The label (package insert) carries the typical "cop out" warning/assurance" which reads Meperidine should not be used in pregnant women prior to the labor period, unless in the judgement of the physician the potential benefits outweigh the possible hazards, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development. Meperidine appears in the milk of nursing mother receiving the drug.
For more information from the manufacturer call or write:
Wyeth-Ayerst Pharmaceuticals
Div. American Home Prod. Corporation
P.O. Box 8299
Philadelphia, PA 19101
Direct inquiries to: (800) 34-5556

METOCLOPRAMIDE INJ.
Mnfr: BAXTER PHARM. PROD. INC.
ALL INFORMATION HAS BEEN OMITTED FROM THE PDR
Not FDA approved for pregnancy, labor, delivery or lactation.
For information from the manufacturer call or write:
Baxter Pharmaceutical Prod. Inc.
96 Spring St.
New Providence, NJ 07974
Direct inquiries to: (800) 262-3784

NARCAN Inj. (naloxone)
Mnfr: ENDO PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 1206
Narcan (naloxone HCl) is an opioid antagonist. It is a synthetic congener of oxymorphone. It is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids. The patient who has satisfactorily responded to Narcan should be kept under continued surveillance, and repeated doses of Narcan should be administered as necessary, since the duration of action of some opioids may exceed that of Narcan's action. There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Narcan should be used during pregnancy only if clearly needed. It is not known if Narcan affects the duration of labor and/or delivery, or if the drug is excreted in human milk. The safety and effectiveness of Narcan in the treatment of hypotension in neonates with septic shock have not been established. The abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest that may result in death. Narcan should not be administered to the newborn unless the newborn's depression is related to drug exposure. Narcan can intensify depression when that depression is unrelated to drug exposure.
For more information from the manufacturer call or write:
Endo Pharmaceuticals Inc.
223 Wilmington West Chester Pike
Chadds Ford, PA 19317
Direct inquiries to: (800) 877-3636

NESACAINE (chloroprocaine hcl)
Mnfr. ASTRAZENECA LP
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 583
For information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800) 236-9933

PARLODEL (bromocriptine mesylate)
Mnfr. NOVARTIS
ALL INFORMATION HAS BEEN OMITTED FROM THE PDR
Parlodel, once approved by the FDA for use in obstetrics, has been removed from the market. In 1997 Parlodel was produced by Sandoz Pharmaceuticals. The company did not note in the package insert that the drug was indicated for the suppression of lactation. However, the text of the package insert mentioned the postpartum use of the drug several times in the Indications section, without warning that 30 cases of stroke had been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated.
For more information from the manufacturer call or write:
Novartis Pharmaceuticals
59 Route 10
East Hanover, NJ 07936
Medical Information(888) 669-6682

PHENERGAN (promethazine inj)
Mnfr: WYETH-AYERST
NOT Approved by FDA for obstetric sedation during labor. PDR pg. 3416
Promethazine relieves the nausea and vomiting caused by the administration of meperidine or other powerful pain relievers. Promethazine is thought to potentiate the effects of pethidine by allowing less of the latter drug to be used; however, the drug is not without risk. The manufacturer warns that Phenergan injection received within two weeks of delivery may inhibit platelet aggregation in the newborn. Research by Corby has shown that promethazine markedly impairs platelet aggregation in the fetus and newborn, a condition which can cause bleeding within the brain of the fetus and newborn without similar effect in the mother.
For more information from the manufacturer call or write:
Wyeth-Ayerst Pharmaceuticals
Div. of American Home Products Corporation
P.O. Box 8299
Philadelphia, PA 19101
Direct inquiries to: (610) 688-4400

PROSTIGMIN (neostigmine methysulfate)
Mnfr. ICN PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 1543
The drug is used to treat postoperative distention and urinary retention. Because of the potential for serious adverse reactions from Prostigmin in nursing infants a decision should be made whether to discontinue the nursing or to discontinue the drug.
For more information from the manufacturer call or write:
ICN Pharmaceuticals
3300 Hyland Ave
Costa Mesa, CA 92626
Direct inquiries to: (800) 548-5100 x 3531

PROSTIN E2 (dinoprostone)
Mnfr: PHARMACIA & UPJOHN
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2638
The manufacturer warns "Prostin E2 vaginal suppository should not be used for cervical ripening"- (a process in which the drug causes the cervix to soften, efface and dilate). "Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities." In the patients studied, temperature elevations in excess of 2*F (1.1*C) were observed in approximately half of the patients on the recommended dosage. Temperature returned to normal on discontinuation of therapy. Other adverse effects noted by the manufacturer, listed in decreasing order of frequency, are vomiting, diarrhea, nausea, fever, headache, chills or shivering, backache, joint inflammation or pain (new or exacerbated, flushing or hot flashes, dizziness, arthralgia, vaginal pain, chest pain, dyspnea, endometritis , syncope or fainting, vaginitis or vulvitis, weakness, muscle cramp or pain, tightness in chest, nocturnal leg cramps, uterine rupture, breast tenderness, blurred vision, coughing, rash, myalgia, stiff neck, dehydration, tremor, paresthesia, hearing impairment, urine retention, pharyngitis, laryngitis, diaphoresis, eye pain, wheezing, cardiac arrhythmia, skin discoloration, vaginismus, and tension.
For more information from the manufacturer call or write:
Pharmacia & UpJohn
100 Route 206
North Peapack, New Jersey 07977
Direct inquiries to: (888) 768-5501

PROZAC (fluoxetine HCl)
Mnfr: DISTA PRODUCTS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 1127
Prozac is an antidepressant for oral administration. It is also an antiobsessive-compulsive, and an antibulimic. Prozac crosses the placenta and enters the fetal circulatory system. Therefore may have adverse effects on the newborn. Prozac should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness in pediatric patients have not been established.
For more information from the manufacturer call or write:
Dista Products Company
Direct inquiry to: Lilly Research Laboratories
Lilly Corporate Center
Indianapolis, Indiana 46285
Tel: (800) 545-5979

RAPLON (rapacuronium bromide)
Mnfr: ORGANON
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2284
Withdrawn from market March 29, 2001 following five deaths due to bronchospasm. Administered as an adjunct to general anesthesia to facilitate tracheal intubation.
For more information from the manufacturer call or write:
Organon Inc.
375 Mt. Pleasant Ave.
West Orange, NJ 07052
Direct Inquiries to: (972) 325-4500

REGLAN (metoclopramide)
Mnfr: A.H.ROBINS COMPANY
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 2713
Reglan is indicated for the relief of symptoms associated with acute and recurrent heartburn and delay in gastric emptying. Reglan injectable is given intramuscularly near the end of surgery to prevent postoperative nausea and vomiting. There are no adequate and well-controlled studies in pregnant women.
For more information from the manufacturer call or write:
A.H. Robins Company
1407 Cummings Drive
Richmond, Virginia 23220
Direct inquiries to: (610) 688-4400

ROBINUL Inj. (glycopyrrolate inj.)
Mnfr: A.H. ROBINS COMPANY
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2017
Robinul Injectable is used to reduce the volume of gastric secretions. It is a synthetic anticholinergic that inhibits the action agent.
For more information from the manufacturer call or write:
A.H. Robins Company
1407 Cummings Drive
Richmond, Virginia 23220
Direct inquiries to: (610) 688-4400

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 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

SUBLIMAZE (sufentanil citrate)
Mnfr: TAYLOR PHARMACEUTICALS
ALL INFORMATION HAS BEEN OMITTED FROM THE PDR.
Not FDA approved for pregnancy, labor, delivery or lactation
For more information from the manufacturer call or write:
Taylor Pharm.: An Akorn Comp.
942 Calle Negocio, Ste.150
San Clemente, CA 92673
Direct inquiries to: (800) 223-9851

THIOPENTAL SODIUM
Mnfr: BAXTER PHARMACEUTICAL
ALL INFORMATION HAS BEEN OMITTED FROM THE PDR
Not FDA approved for pregnancy, labor, delivery or lactation.
For information from the manufacturer call or write:
Baxter Pharmaceutical Prod. Inc.
96 Spring St.
New Providence, NJ 07974
Direct inquiries to: (800) 262-3784

TORADOL (ketorolac tromethamine)
Mnfr: ROCHE PHARMACEUTICALS
Not approved for pregnancy, labor, delivery or lactation. PDR pg. 2789
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

TOPROL-XL (metoprolol succinate)
Mnfr: ASTRAZENECA LP
Not approved for pregnancy, labor, delivery or lactation.PDR pg. 606
Used to treat hypertension.
For more information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800)236-9933

VALIUM (diazepam)
Mnfr: ROCHE PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2814
Valium (diazepam) is indicated for the management of anxiety disorders or for the short-term symptoms of anxiety. It is not FDA approved for use in obstetrics. An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. For more information from the manufacturer call or write:
Roche Pharmaceuticals
340 Kingsland Street
Nutley, NJ 07110
Direct inquiries to: (800) 526-6367

VISTARIL (hydroxyzine HCl)
Mnfr: PFIZER
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2541
Vistaril (hydroxyzine HCl is a rapid-acting drug that includes a calming effect in anxious, tense, pre and postpartum patients to permit reduction in narcotic dosage and control vomiting. The potentiating action of hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, barbiturates, and alcohol. Rare, cardiac arrests and death have been reported in association with the combined use of hydroxyzine hydrochloride IM and other CNS depressant. When CNS depressants are administered concomitantly with hydroxyzine their dosage should be reduced up to 50 per cent. Meperidine should be used with great caution and in reduced dosage in patients who are receiving other pre-and/or postoperative medications and in whom there is a risk of respiratory depression, hypotension, and profound sedation or coma occurring. Before using any medications concomitant with hydroxyzine, the manufacture's prescribing information should be read carefully.
For more information from the manufacturer call or write:
Pfizer Inc
235 East 42 Street
New York, New York 10017-5755
Direct inquiries to: (800)438-1985

XYLOCAINE (lidocaine hcl)
Mnfr: ASTRAZENACA
Not FDA approved for pregnancy, labor, delivery or lactation.PDR pg. 607
For more information from the manufacturer call or write:
AstraZeneca LP
Wilmington, DE 19850
Direct inquiries to: (800) 236-9933

ZOFRAN (ondansetron)
Mnfr: GLAXO WELCOME INC.
Not approved for pregnancy, labor, delivery or lactation. PDR pg. 1503
Administered postoperatively to prevent nausea and vomiting.
For more information from the manufacturer call or write:
Glaxo Wellcome Inc.
Five Moore Drive
Research Triangle Park, NC 27709
Direct inquiries to: (800) 334-0089


Special Notice: ACCUTANE (isotretinoin)
Mnfr: R0CHE PHARMACEUTICALS
Not FDA approved for pregnancy, labor, delivery or lactation. PDR pg. 2721
This drug has been approved by the FDA only for the treatment of cystic acne. Fetal exposure to the drug in utero may lead to significant birth defects, therefore the drug must be prescribed under stringent conditions that rule out the likelihood of pregnancy during treatment or within one month of discontinuing treatment.
For more information from the manufacturer call or write:
Roche Laboratories
340 Kingsland Street
Nutley, N.J.07110
Direct inquiries to: (800) 526-6367