Drugs should be given only if the potential benefit justifies the potential risk to the fetus. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk e. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. Information from Collins E. Maternal and fetal effects of acetaminophen and salicylates in pregnancy. The controversy surrounding indomethacin for tocolysis. Am J Obstet Gynecol ;— Oral decongestant of choice 10 , possible association with gastroschisis 9. Food and Drug Administration. First trimester maternal medication use in relation to gastroschisis.
Teratology ;—7, and The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol ;— Salicylates have been associated with increased perinatal mortality, neonatal hemorrhage, decreased birth weight, prolonged gestation and labor, and possible birth defects. Pregnant women should use salicylates only under the guidance of a medical professional.
Physicians may employ indomethacin during pregnancy to treat pain from degenerating leiomyomata, or as a tocolytic agent. Unfortunately, indomethacin use during pregnancy may result in oligohydramnios, premature closure of the fetal ductus arteriosus with subsequent persistent pulmonary hypertension of the newborn, fetal nephrotoxicity, and periventricular hemorrhage. However, an analysis 8 of 50 pregnant patients who overdosed on ibuprofen revealed no evidence of fetal abnormalities.
Because of the possibility of adverse effects of NSAIDs on the fetus, it is our opinion that these medications should be used sparingly during pregnancy. Women commonly use cold medications during pregnancy. These medications, like most of the other OTC drugs, have not been studied well in pregnancy Table 3.
The most commonly used cold medications include decongestants and expectorants such as pseudoephedrine Novafed , guaifenesin Humibid L. The use of vasoconstrictive agents such as pseudoephedrine may activate alpha-adrenergic receptors, elevating blood pressure or causing vasoconstriction in the uterine arteries, and potentially adversely affecting blood flow to the fetus. This process could explain the reported association between the use of pseudoephedrine in the first trimester and the development of gastroschisis.
Diphenhydramine is widely used in pregnancy as a sedative, an antihistamine, and an anti-nausea drug, although few data confirm its safety during pregnancy. The drug has been shown to have oxytocin-like effects, especially in high dosages. For example, one study 13 showed a significant increase in fetal morbidity when diphenhydramine was taken in combination with temazepam Restoril.
In , the American College of Obstetricians and Gynecologists and the American College of Allergy, Asthma, and Immunology released a position statement 10 regarding the use of asthma and allergy medications, including antihistamines and oral decongestants. Chlorpheniramine and tripelennamine PBZ were recommended as antihistamines of choice.
Pseudoephedrine was recommended as the oral decongestant of choice, based on animal studies and a large prospective human experience with the drug during pregnancy. However, because pseudoephedrine may be associated with gastroschisis and because other choices are available, it may be prudent to avoid using this medication during the first trimester unless the benefit outweighs the risk.
Dextromethorphan has been associated with birth defects in chicken embryos. The Collaborative Perinatal Project 14 monitored 50, pregnant women, of whom were exposed to dextromethorphan in the first trimester.
Birth defects did not increase above the baseline rate. Another study 15 of 59 women who had used dextromethorphan in the first trimester documented one malformation. Thus, sufficient evidence indicates a lack of adverse effects of dextromethorphan use during pregnancy.
When used during the first trimester in the presence of a febrile illness, guaifenesin has been associated with an increased risk of neural tube defects. The safety of the various agents is outlined in Table 4.
A possible association has been identified between the ingestion of clays containing kaolin and the development of iron deficiency anemia. Loperamide has not been found to be teratogenic in animals. However, at least one study 4 involving first-trimester exposure in humans showed a possible increase in fetal cardiac malformation. Several antacids are available in OTC forms, including preparations that contain alginic acid, aluminum, magnesium, and calcium. All of these preparations generally are regarded as safe in pregnancy Table 5.
There have been sporadic reports of fetal maldevelopment and injury associated with prolonged use of high dosages of aluminum-containing antacids during pregnancy. Magnesium compounds contain magnesium sulfate, a known tocolytic agent. Despite the minimal magnesium absorption that occurs with antacid ingestion, some clinicians prefer the use of calcium-containing preparations.
Simethicone Mylanta Gas is not absorbed. The histamine H 2 -receptor blockers are effective in treating symptoms of heartburn and gastroesophageal reflux disease in pregnancy, 20 but these drugs readily cross the placenta. Studies of these agents generally have shown significant improvement of symptoms with no significant adverse effects.
Animal studies also fail to show an increased fetal risk with the use of these medications in pregnancy, the notable exception being nizatidine Axid. The OTC doses are one half of the prescription strength. Although studies have indicated that there is probably no increased risk of fetal morbidity or mortality, few studies have evaluated first-trimester use of H 2 blockers.
Therefore, most investigators recommend avoiding these drugs in the first trimester. The most common antifungal medications available as OTC drugs include the imidazole agents clotrimazole Mycelex , butoconazole Femstat , miconazole Monistat , and tioconazole Vagistat Table 6 23 , 24 describes the safety of various OTC antifungal agents in pregnancy. One of the largest studies 24 to date investigated the teratogenicity of clotrimazole. The population-based, case-control study of 18, case pregnancies and 32, control pregnancies did not show an association between fetal malformations and the use of clotrimazole.
Several small trials have indicated that butoconazole and miconazole are likely to be safe during the second and third trimesters. Insufficient data are available regarding the safety of tioconazole in pregnancy. Many clinicians use oral fluconazole Diflucan to treat vulvovaginal candidiasis. A study 26 of women exposed to fluconazole during the first trimester of pregnancy revealed that patients taking fluconazole were no more likely than unexposed control patients to experience miscarriage, stillbirth, or congenital anomalies.
Ketoconazole Nizoral , flucytosine Ancobon , and griseofulvin Grisactin may be teratogenic or embryotoxic in animals.
The Centers for Disease Control and Prevention recommends using only topical vaginal antifungal agents including butoconazole, clotrimazole, miconazole, and the prescription medications terconazole [Terazol] and nystatin [Mycostatin] in pregnancy. Nicotine replacement therapy presents an interesting clinical dilemma.
Researchers believe that nicotine and its metabolic byproduct, cotinine, are harmful to the developing fetus because smoking is known to cause harmful fetal effects, including intrauterine growth retardation, premature birth, hyperviscosity in the newborn, spontaneous abortion, fetal neurotoxicity, and pulmonary defects, and an increased risk of sudden infant death syndrome. The primary mechanism of these deleterious effects is believed to be uteroplacental insufficiency.
Reduced perfusion of oxygenated blood through the placenta at various stages of development may cause the various manifestations of fetal maldevelopment and injury.
Safe in second and third trimesters human trials , 24 first trimester probably safe Information from Lagace E. Safety of first trimester exposure to H 2 blockers. No teratogenic effect after clotrimazole therapy during pregnancy. Epidemiology ;— They should be taken starting at least six weeks prior to conception. Your doctor will suggest that you continue throughout the pregnancy and until three months after delivery.
Learn more: The ABCs of vitamins in pregnancy. Tylenol acetaminophen , , mg every 4 hours as needed. Do not take more than 4, mg in 24 hours. Tavist Allergy, 1 tab every 12 hours Benadryl mg every hours Sudafed pseudoephedrine 1 tab every hours after 12 weeks gestation Claritin 10 mg daily Zyrtec 10 mg daily Clor-Trimetron chlorpheniramine. Cepacol Maximum Strength sore throat spray or Sucrets dyclonine hydrochloride Chloraseptic lozenges benzocaine or spray phenol Halls or Robitussin lozenges menthol Vicks Lozenges with honey dextromethorphan hydrobromide.
Gynazole-1 butoconazole Gyne-Lotrimin clotrimazole Monistat-7 vaginal cream miconazole. Written by Jeffrey Boyle, MD.
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Pregnant or planning a pregnancy? Reporting side effects Data sources Disclaimer What it is used for Fast, long lasting relief from the burning pain of heartburn , indigestion and gastric reflux.
How to take it The way to take this medicine is: Oral. This medicine is taken by mouth. Store below 30 degrees Celsius Shelf lifetime is 2 Years. Always read the label.
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