ALBUTEROL: Pregnancy: Teratogenic Effects: Pregnancy Category C. Albuterol sulfate has been shown to be teratogenic in mice . . . .cleft palate formation. A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 fetuses (37%) when albuterol sulfate was administered orally . . . In an inhalation reproduction study in New Zealand white rabbits, albuterol sulfate/HFA-134a formulation exhibited enlargement of the frontal portion of the fetal fontanelles. . . .A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. There are no adequate and well-controlled studies of VENTOLIN HFA or albuterol sulfate in pregnant women. VENTOLIN HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. . . .Use in Labor and Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Tocolysis: Albuterol has not been approved for the management of preterm labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol.
ATROVENT Inhalation Aerosol Category B should be used during pregnancy only if clearly needed.Pregnancy. . . . . .no adequate or well controlled studies have been
conducted in pregnant women. Because animal reproduction studies are not always
predictive of human response, ATROVENT Inhalation Aerosol should be used during
pregnancy only if clearly needed.
ANTI-COAGULANTS: Prenatal exposure to oral anticoagulants [warfarin/coumadin] during pregnancy may result in defective fetal development or life-threatening hemorrhage. Fetal exposure during the first eight weeks of pregnancy may cause abnormal development of the facial structures, hypoplastic digits, strippled epiphyses, and mental retardation. Midtrimester exposure may result in optic atrophy, faulty brain growth, and developmental retardation. Third-trimester exposure may produce fetal anticoagulation, predisposing the infant to life-threatening hemorrhage in the perinatal period. Anticoagulation with heparin sodium does not provide a clearly safe alternative, since this therapy has been associated with excessive fetal loss. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7359739&dopt=Abstract
Heparin: Pregnancy Category C. Animal reproduction studies have not been conducted with heparin sodium. It is also not known whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Nonteratogenic Effects: Heparin sodium does not cross the placental barrier.
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
http://www.aimsusa.org/ObstetricDrugs-NotApproved.htm
Risk assessment is an important part of prenatal care. You and your husband's autonomous decision should be based upon factual information. Both you and your husband are entitled to professional prenatal counseling. Most insurance plans cover the cost of prenatal counseling for "at-risk" pregnancies. Most obstetrical practices have genetic and prenatal counselors who provide information and assist the mother and father with risk assessment. This is your right and your duty to your two children and also to the fetus. Medical ethics is based upon the principles of beneficence, non-maleficence, and autonomy. Beneficence which means a physician should act in the best interest of his patient. Non-maleficence means a physician should "first, do no harm". Autonomy means that the patient has the right to refuse or choose their treatment. With respect to first trimester abortion, legally you are entitled to terminate your pregnancy due to risk to your life and well-being. You and your husband will have to live with your decision for the rest of your lives. It is a decision nobody can make for you. You must consider the consequences of your autonomous informed decision BEFORE you decide.
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