Medications Considered Safe for use During Pregnancy



Medications Considered Safe for Use During Pregnancy

W hether you have been exposed to a chest x-ray, an infection, a chemical, or a drug during pregnancy you may find some comfort in the knowing that the majority of such exposures do not result in birth defects or other risks to the fetus. Nonetheless, you should be aware that most drugs cross the placenta, and that there is little information about the first-trimester effects for many drugs in human pregnancy. Therefore make sure to ask your doctor before starting a medication during pregnancy. Also make sure to ask your doctor before you stop taking a medication such as levothyroxine (Synthroid, Levoxyl) or insulin, since untreated illnesses can have a harmful effect on your pregnancy.

Medications and Potential Teratogens in Pregnancy

An agent that causes a birth defect to occur at a higher rate than expected is called a teratogen. The agent may be a chemical, a drug, an infection, radiation, or a maternal condition such as diabetes. It is often difficult to determine whether a bad outcome was related to a specific external agent since there may be many factors responsible including a mother’s underlying illness .

Most teratogens produce their effect during the sensitive 5th to the 10th week (embryonic period) of development when the major organs are forming . For example, thalidomide causes limb defects when taken during the the 21st to the 36th day after conception, and tetracyclines do not produce their effects until after the first trimester when the skeletal system begins to form bone. However, some drugs such as ethanol may produce harmful effects on functional development throughout pregnancy.

Table 1. Gestational Age When Organ Systems are Most Sensitive to Birth Defects.

Developmental stage Embryonic Stage Fetal Stage Gestational Age (Months) 1 2 3 Gestational Age (Weeks) 1 2 3 4 5 6 7 8 9 10 11 12 13 Postconception Age (weeks) 0 0 1 2 3 4 5 6 7 8 9 10 11 Developing Organ(s) CNS* Heart Ear Eyes Limbs Lip Palate Teeth External genitals Weight ounces 1.3 1.6 2 2.6 grams 35 45 58 73 Length inches 0.16 0.39 0.63 0.91 1.22 1.61 2.13 2.64 centimeters 0.4 1 1.6 2.3 3.1 4.1 5.4 6.7

The red bars in the table show the gestational age when different organ systems are most sensitive to major birth defects in that organ system. The gray bars show the gestational age when different organ systems are sensitive to functional defects and minor malformations.

Some agents show a strong dose-response effect with less severe birth defects occurring at lower doses. For other agents such as radiation there appears to be a minimum threshold level (5 rads) below which exposure to the agent is not believed to cause birth defects.

Developmental Stage Calculator Find out how far along you were in pregnancy when you were exposed to an agent.

The Food and Drug Administration (FDA) created the following rating system in 1979 to categorize the potential risk to the fetus for a given drug.

Category A: Controlled human studies have demonstrated no fetal risk Category B: Animal studies indicate no fetal risk, but no human studies OR adverse effects in animals , but not in well- controlled human studies Category C: No adequate human or animal studies, OR adverse fetal effects in animal studies, but no available human data. Category D: Evidence of fetal risk, but benefits outweigh risks. Category X: Evidence of fetal risk. Risks outweigh any benefits.

Unfortunately this system oversimplifies the issues relevant to prescribing a medication to a pregnant patient. For example, the FDA system does not adequately address the risk of not treating a disease versus the risks of the medication, and t here is a tendency to assume that a category B drug is safer for human use than a category C drug when there may be no human studies available to support the assumption. In addition the system is not easy to apply to combination prescription drugs with many active ingredients and the potential for drug interactions. Despite its shortcomings the FDA rating system (and others like it) will most likely continue to be used as a rapid “first screen” on the the potential risk to the fetus for a given drug. See proposed changes to FDA Pregnancy and Lactation Labeling

Table 2 below is a list of some medications that appear to have demonstrated no significant fetal risk in human studies [1-16]

Table 2. Some Medications Considered Safe for Use During Pregnancy

Condition

Medication

Asthma

  • Budesonide inhaled or nasal spray (Pulmicort, Rhinocort )

Bladder infection (UTI)

  • Nitrofurantoin (Macrobid) – Avoid in patients with possible G6PD deficiency

Cough

  • Dextromethrophan ( Robitussin DM sugar free )

Constipation

  • Metamucil , Citrucel,
  • Docusate (Colace, Ducolax )
  • Milk of magnesia.
  • Polyethyelene glycol (Miralax)

Diabetes

  • Insulin
  • Glyburide (Micronase)
  • Metformin (Glucophage)

Diarrhea

  • Loperamide (Imodium A-D )

Gas

  • Simethicone (Gas-X , Mylicon , Phazyme )

Gastroesophageal reflux disease (GERD),

  • Ranitidine (Zantac)
  • Cimetidine (Tagamet)

Hayfever, sneezing, runny nose, itchy watery eyes

  • Chlorpheniramine (Chlor-Trimeton ,Efidac , Teldrin )
  • Diphenhydramine (Benadryl ) Clemastine (Tavist Allergy )

Headache or fever:

  • Acetaminophen (APAP,Paracetamol,Panadol, Tylenol)

Heartburn

  • TUMs

Hemorrhoids

  • Tucks
  • Preparation H
  • Anusol

High blood pressure

  • Methyldopa (Aldomet)

Hyperprolactinemia

  • Bromocriptine (Parlodel)
  • Carbergoline (Dostinex)

Hypothyroidism

  • Thyroid hormone
  • Levothyroxine (Synthroid , Levoxyl )

Infection

  • Acyclovir (Zovirax )
  • Azthitromycin (Zithromax )
  • Cepaholosporins examples: Cephalexin (Keflex), Cefazolin (Ancef ), cefaclor (Ceclor)
  • Clindamycin (Cleocin)
  • Erythromycin
  • Penicillins example Amoxicillin (Amoxil), Amoxicillin Clavulanate (Augmentin), methicillin, carbenicillin
  • Metronidazole (Flagyl)

Insomnia

Motion sickness

  • Dimenhydrinate (Dramamine )

Nasal congestion

  • Pseudoephedrine (Sudafed ) -Avoid in first trimester.

Nasal congestion, sneezing, runny nose, itchy watery eyes

  • Actifed Cold and Allergy
  • Ingredients: Triprolidine, Pseudoephedrine -Avoid in first trimester.

Nasal congestion, sneezing, runny nose, itchy watery eyes, fever, and headache

  • Actifed Cold and Sinus
  • Ingredients: Acetaminophen, Chlorpheniramine, Pseudoephedrine- Avoid in first trimester.

Nausea

  • Ginger
  • Pyridoxine 25 mg PO TID WITH
  • Unisom Sleep Tabs (Doxylamine Succinate 25 mg) 1/2 tablet TID
  • Metoclopramide (Reglan
  • )

Preeclampsia

  • Magnesium sulfate

Vaginal yeast infection

  • Clotrimazole cream (Gyne-Lotrimin)

Printable Table

SEE ALSO:Medications and Diagnostic Agents in Pregnancy

REFERENCES:

1. Schatz M, Zeiger RS, Harden K, Hoffman CC, Chilingar L, Petitti D. The safety of asthma and allergy medications during pregnancy. J Allergy Clin Immunol. 1997 100:301-6. 1997. PubMed

2. Briggs GG, Freeman RK, Yaffee FJ. Drugs in Pregnancy and Lactation: Reference Guide to Fetal and Neonatal Risk. 7th ed. Baltimore: Williams & Wilkins; 2005.

3. Martinez-Frias ML, Rodriguez-Pinilla E. Epidemiologic analysis of prenatal exposure to cough medicines containing dextromethorphan: no evidence of human teratogenicity. Teratology, 63:38-41. 2001 PubMed

4. Einarson A, Lyszkiewicz D, Koren G. The safety of dextromethorphan in pregnancy : results of a controlled study. Chest. 119:466-9. 2001 PubMed

5. Shaw GM, Todoroff K, Velie EM, Lammer EJ: Maternal illness, including fever, and medication use as risk factors for neural tube defects. Teratology 57:1-7, 1998. PubMed

6. Aselton P, Jick H, Milunsky A, Hunter JR, Stergachis A. First-trimester drug use and congenital disorders. Obstet Gynecol. 65:451-5. 1985. PubMed

7. Limitations of Pregnancy Risk Categories . Ob.Gyn. News 01 March 2001

8. Reproductive Toxicology Center. Bethesda, Md. Available at http://reprotox.org. Accessed 11/1/ 07.

9. Czeizel AE,Augmentin treatment during pregnancy and the prevalence of congenital abnormalities: a population-based case-control teratologic study. Eur J Obstet Gynecol Reprod Biol. 2001 Aug;97(2):188-92. PMID: 11451547

10 .Czeizel AE,Nitrofurantoin and congenital abnormalities.Eur J Obstet Gynecol Reprod Biol. 2001 Mar;95(1):119-26. PMID: 11267733

11. Czeizel AE,Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: a population-based, case-control study.Am J Obstet Gynecol. 2001 May;184(6):1289-96. PMID: 11349204

12. Czeizel AE, et al. A population-based case-control teratologic study of oral erythromycin treatment during pregnancy.Reprod Toxicol. 1999 Nov-Dec;13(6):531-6. PMID: 10613401

13. Nrgrd B,Population-based case control study of the safety of sulfasalazine use during pregnancy. Aliment Pharmacol Ther. 2001 Apr;15(4):483-6. PMID: 11284776

14. Czeizel AE and Vargha P.,A case-control study of congenital abnormality and dimenhydrinate usage during pregnancy. Arch Gynecol Obstet. 2005 Feb;271(2):113-8. Epub 2004 Oct 23. PMID: 15517327

15. Rockenbauer M,et al. Recall bias in a case-control surveillance system on the use of medicine during pregnancy. Epidemiology. 2001 Jul;12(4):461-6. PMID: 11416783

16. Czeizel AE,et al.No teratogenic effect after clotrimazole therapy during pregnancy. Epidemiology. 1999 Jul;10(4):437-40. PMID: 10401880

Created: 12/18/2002 Mark A Curran, M.D. Update: 11/2/2004

Update: 8/24/2006 Update: 12/4/2007 Update: 12/12/2007 Update: 12/12/2008

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