Demetria Clark
Doula Services
48 Commonwealth Ave.
Springfield VT 05156

Common OTC Drugs and Pregnancy
The Food and Drug Administration (FDA) uses the following rating system 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.
Tylenol (Acetaminophen)-
Category B - drugs that have been used a lot during
pregnancy and do not appear to cause major birth defects or other problems. Tylenol
does appear to cross the human placenta. Three studies involving more than 10,000
newborns exposed to acetaminophen during the first trimester did not find an associa-
tion between acetaminophen and major malformations. Tylenol should not be used over
the long term.
Ibuprofen– Some common brands are Advil and Motrin. This drug is a class B until the
3rd trimester, then it is a class D. Borderline association with gastroschisis [1].
All NSAIDs used near term may cause premature closure of the ductus arteriosus, and
inhibit labor. Oligohydramnios after prolonged use is a common complication with
NSAIDs as a class. There are no adequate studies of ibuprofen in pregnant women.
Therefore, ibuprofen is not recommended during pregnancy. [2]
Benadryl (diphenhydramine hydrochloride)– Category B in third trimester. But in
the 1st and 2nd trimester Diphenhydramine has been used extensively in pregnant
women; the incidence of fetal malformations is the same as that which would be ex-
pected in women who are not taking medications. Diphenhydramine may cause uterine
irritability or contractions near term when used in high doses (greater than 50mg) [4,5]
Sudafed (pseudoephedrine) Class C in pregnancy. It is recommended that one
doesn’t use it because of some associated problems that occur along with gastroschisis
are preterm birth, intrauterine growth restriction and cardiac problems. If you feel that
you need this or a similar type of drug, please visit you physician.[6, 7]
Cough Syrup– There are a variety of honey based natural cough syrups on the market
and others in drug stores, please read the bottle before using about contraindications.
Check this product's ingredient list for phenylpropanolamine (PPA). The FDA has issued
warnings regarding PPA side effects. Do not use if Dextromethorphan is present it is
the focus of a recent controversy, following a report that dextromethorphan induced
miscarriage and malformations, such as open neural tube defects, in chick embryos in-
Demetria Clark
jected with dextromethorphan. [8]. Contact your health care provider about the specific
brand.An increased incidence of inguinal hernias was noted in a retrospective study of 197
women with first trimester exposure to guaifenesin [9]. Other retrospective studies have
not, however, found an increased incidence of malformations associated with guaifenesin
exposure during the first trimester. [10] Overall, the teratogenic risk of guaifenesin is
thought to be low.
Alka Seltzer (Buffered Aspirin Product)- Class D product for pregnancy. Possible Tet-
rogenic actions, linked to prolonged gestation, readily crosses the placenta, post partal
hemorrhage and linked to low birth weight, increased intracranial hemorrhage, stillbirth
and neonatal death. [11]
Tums (Calcium carbonate)- Class D in pregnancy. Extended heavy use of calcium ant-
acids (20 grams or more daily for a prolonged period) may cause excess calcium in the
blood, which can lead to kidney stones and reduced kidney function. People who already
have impaired kidneys may develop milk-alkali syndrome (causing symptoms such as
nausea, vomiting, mental confusion, and loss of appetite) with as little as 4 grams a day.
Mylanta (Aluminum and Magnesium Hydroxide w/or without Simethicone) -
Class C in pregnancy. There have been sporadic reports of fetal maldevelopment and in-
jury associated with prolonged use of high dosages of aluminum-containing antacids dur-
ing pregnancy.

With any herbs or drugs know what you are taking. Ask your physician or look the drug
up, some places online that are good resources are:
1.Torfs et al.Teratology 54:84,1996
2, 3, 11. .Karch, Amy , M. 2005 Lippincott’s Nursing Drug Guide. Lippincott Williams and Wilkins.
New York. 2005
4. Hara GS et al. J Kans Med Soc. 1980;81:134-6,155. MEDLINE
5. Brost BC, Diphenhydramine overdose during pregnancy: lessons from the past. Am J Obstet Gy-
necol. 1996;175:1376-7. MEDLINE
6.Werler MM, et al Maternal medication use and risks of gastroschisis and small intestinal atresia.
Am J Epidemiol. 2002;155:26-31
7.Hoyme HE, et al. ;The vascular pathogenesis of gastroschisis: intrauterine interruption of the
omphalomesenteric artery.J Pediatr. 1981;98:228-31
8. Andaloro VJ et al. (1998) Ped Res 43:1-7.
9.Heinonen OP et al: Birth Defects and Drugs in Pregnancy, Littleton
10. Aselton et al. (1985) Obstet Gynecol 65:451-5.
11.Gilbert-Barness E, Barness LA, Wolff J, Harding C. Aluminum toxicity. Arch Pediatr Adolesc Med

Source: http://www.birtharts.org/otcdrug.pdf


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