The use of medications in pregnancy is common, especially those that are over-the-counter (OTC). Most medications are safe in pregnancy, but there are exceptions. The main categories of OTC drugs are cough, cold, runny nose, sinus, sore throat, gastrointestinal (nausea, heartburn, constipation, diarrhea), allergies, and pain.
The respiratory medications include antihistamines (allergies), decongestants (sinus), antitussives (cough), and expectorants (mucus). Prescription medications and vaccines are also given during pregnancy and largely depend on the safety profile, symptom severity, and seriousness of the condition. The safety profile is assessed for both maternal and fetal well-being and each drug is placed into a category based on fetal risk, primarily (A, B, C, D, and X) TABLE 1.
Conditions such as hypertension, asthma, diabetes, and cardiac disease warrant ongoing treatment with appropriate medications in pregnancy, primarily to avoid complications or worsening of the disease. Whereas, pregnancy-related symptoms include nausea and vomiting, allergies, and bacterial infections such as urinary tract infections that can require either OTC or prescription medications.
FDA Classification System for Drugs in Pregnancy
Table 1. FDA Drug Risk Classification (References 2-5)
| Category | Description |
|---|---|
| A | Controlled studies in humans show no risk to the fetus |
| B | No controlled studies have been conducted in humans; animal studies show no risk to the fetus |
| C | No controlled studies have been conducted in animals or humans |
| D | Evidence of human risk to the fetus exists; however, benefits may outweigh risks in certain situations |
| X | Controlled studies in both animals and humans demonstrate fetal abnormalities; the risk in pregnant women outweighs any possible benefit |
The data for TABLE 1 is taken from animal studies and data from humans are based on drug post marketing surveillance reports. Ethically, it is difficult to test new drugs on pregnant women. Limitations of the above classification are:
- New FDA-approved medications are all classified as Category C
- No FDA regulations require additional studies, making reclassification rare.
Drugs that May Cause Birth Defects
Overall, 20-30% of common drugs are teratogens (can cause birth defects) while 7% of 1000 medications in the Physician’s Desk Reference are Category X and should never be used. Specific drugs that are unsafe in pregnancy are warfarin (blood thinner), isotretinoin (acne drug), valproic acid (anti-seizure), and all types of tetracyclines (antibiotic). Risk to the fetus is dependent on the timing of the exposure with the first trimester being the most vulnerable.
OTC Drugs for the Common Cold
There are other options besides drugs to treat common viral infections such as humidifiers, saline sprays or netty pots. TABLE 2 shows the common OTC cold, cough, and allergy drugs. Some allergy drugs can be used for morning sickness.
Table 2. OTC Cough, Cold, and Allergy Medications in Pregnancy ( Source: Reference 1.)
| Drug (Brand) | FDA Pregnancy Category | Drug Class | Crosses Placenta? | Clinical Consideration |
|---|---|---|---|---|
| Chlorpheniramine (Chlor-Trimeton) | B | Antihistamine | Unknown | Oral antihistamine of choice |
| Diphenhydramine (Benadryl) | B | Antihistamine | Yes | Possible oxytocin effects at higher doses |
| Pseudoephedrine (Sudafed) | C | Decongestant | Unknown | Oral decongestant of choice but avoid during first trimester |
| Dextromethorphan (Delsym) | C | Antitussive | Unknown | Appears to be safe in pregnancy |
| Guaifenesin (Mucinex) | C | Expectorant | Unknown | May be unsafe in first trimester |
The first two preferred choices are chlorpheniramine (Chlor-Trimeton), and diphenhydramine (Benadryl); both are Category B. However, they are very sedating.
The second-generation antihistamines, which are non-sedating are loratadine (Claritin), fexofenadine (Allegra), and cetirizine (Zyrtec), and have not been well studied. Cetirizine is the best choice if the first-line choices are not tolerated.]
Inhaled and oral decongestants can be used in pregnancy. Pseudoephedrine (Sudafed) and phenylephrine (Sudafed PE) are commonly used as oral OTC decongestants. Pseudoephedrine should be avoided during the first trimester, however. Inhaled decongestants such as oxymetazoline (Afrin) and phenylephrine (Neo-Synephrine) are both Category C and are considered safe in pregnancy.
Dextromethorphan (Delsym) is the best cough medication to use in pregnancy. Guaifenesin (Mucinex) is an expectorant that helps expel phlegm or mucus associated with viral respiratory infections. It should be avoided in the first trimester.
Pain Relievers
For pain relief, acetaminophen is the most commonly used OTC drug in pregnancy, with at least 50% of women taking some time during their pregnancies, and it is considered a safe drug in pregnancy. This drug should be the drug of choice for high fevers since fevers have been associated with birth defects. It is not recommended that pregnant women use aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) because recent studies showed a moderate association with birth defects and miscarriages. NSAIDs can inhibit labor, damage the fetal kidneys, and cause the closure of the ductus arteriosus—a blood vessel that is necessary for fetal life. Opioids are considered safe in pregnancy for pain not relieved with acetaminophen. However, they are prescription only.
Nausea, Vomiting, and other GI Disturbances
Morning sickness can occur anytime during the day and is usually an indicator of a healthy pregnancy. The nausea and vomiting can become severe in rare cases, and is called hyperemesis gravidarum. Sometimes, hospitalization is required to treat dehydration and control ongoing symptoms. Table 3 lists the different medications for nausea and vomiting.
Heart burn or acid reflux occurs in 30-50% of pregnancies due to the relaxation of the esophageal sphincter and the enlarging uterus. OTC antacids such as Tums or Rolaids are considered the best. TABLE 3 also lists antacids for use in pregnancy.
Diarrhea and constipation are two other pregnancy-associated issues Constipation is more common due to slowed GI motility and from the iron in some prenatal vitamins. Bismuth subsalicylate (Pepto-Bismol, Kaopectate) are not to be used in pregnancy because the salicylate ingredient may increase perinatal mortality.
Table 3. Medications Used to Treat Common GI Problems During Pregnancy
| Class | Drug (Brand) | Clinical Consideration |
| Nausea and Vomiting | ||
| Antihistamines | Dimenhydrinate (Dramamine), diphenhydramine (Benadryl), doxylamine (Unisom), doxylamine/pyridoxine (Diclegis) | May cause drowsiness |
| Phenothiazines | Prochlorperazine (Compazine), promethazine (Phenergan) | Sedation, anticholinergic effects, EPS |
| Benzamides | Metoclopramide (Reglan) | EPS, agitation |
| Serotonin antagonists | Ondansetron (Zofran) | Headache |
| Acid Reflux | ||
| Antacids | Aluminum/magnesium hydroxide (Rolaids, Maalox), calcium carbonate (Tums) | Preferred |
| Mucosal protectants | Sucralfate (Carafate) | Minimal systemic absorption; considered low risk |
| H2 antagonists | Cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac) | Considered low risk; avoid first-trimester use; ranitidine is the most studied, making it the preferred agent |
| Proton pump inhibitors | Esomeprazole (Nexium), omeprazole (Prilosec), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex) | Increased risk of hypospadias has been reported |
| Diarrhea | ||
| Antidiarrheals | Alosetron (Lotronex), diphenoxylate/atropine (Lomotil), loperamide (Imodium) | Alosetron is only approved for use in patients with IBS-related diarrhea who have failed conventional therapy |
| Constipation | ||
| Osmotic laxatives | Lactulose (Enulose), magnesium citrate (Citroma), PEG (MiraLax) | Considered low risk |
| Stimulant laxatives | Bisacodyl (Correctol), Senna (Senokot) | Short-term use |
| Stool softener | Docusate (Colace) | Short-term use |
EPS: extrapyramidal symptoms; GI: gastrointestinal; IBS: irritable bowel syndrome; PEG: polyethylene glycol. References 14-17
Vaccines
The immunizations that cannot be given in pregnancy are live vaccinations, which include live-attenuated influenza vaccine (LAIV); measles, mumps, and rubella (MMR); varicella; and zoster. Recommended vaccines are non-live influenza vaccine and a few others that your doctor will discuss with you.
Conclusion
Seek your medical doctor's professional advice if you are unsure whether a medicine is okay to use while pregnant. Ask about recent studies as well because new findings may cause the labeling of pregnant medications to alter.
Key Takeaways
Never consume more than the recommended dose; only the smallest effective dose should be used. To verify dose information, read the label and speak with your healthcare professional.
Never stop using drugs that have been prescribed to you without first consulting your doctor.
Depression treatment is crucial throughout pregnancy. The majority of antidepressants are safe to use while expecting, but some others need to be explored with your psychiatrist and OB/GYN.
Particularly if used during the first trimester, phenylephrine and pseudoephedrine (DayQuil, Sudafed, Claritin-D) may cause gastrointestinal abnormalities or disrupt blood flow to the placenta.
In most cases, if your doctor gives you an antibiotic while you're pregnant, it's because the infection it's treating is more serious than any possible negative effects of taking the medication.
References
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