From the FDA Drug Label
- 1 Pregnancy Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
- Insufficient data exists to determine the safety of Famotidine during pregnancy.
- The drug label states that available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes 1.
- Therefore, no conclusion can be drawn about the safety of Famotidine during pregnancy.
From the Research
Safety of Famotidine During Pregnancy
- The safety of famotidine during pregnancy is a concern, as with many other medications, due to the potential teratogenicity of medications 2.
- However, studies have shown that famotidine, a H2-receptor antagonist, is commonly used to treat heartburn and gastroesophageal reflux disease during pregnancy, and information on its pharmacokinetics in pregnant patients is limited 3.
- A physiologically based pharmacokinetic (PBPK) model for famotidine in non-pregnant and pregnant populations was developed and evaluated, and the results suggested that famotidine exposure was predicted to be decreased by 24% in mid-pregnancy and 20% in late pregnancy compared to non-pregnant populations 3.
- Preclinical safety studies with famotidine have been performed, and no evidence of teratogenic, mutagenic, or carcinogenic effects or alterations of reproductive function have been seen 4.
- However, it is essential to note that current reference guides for the safe use of drugs during pregnancy are less scientific and reliable, and there are considerable discrepancies in recommendations from different reference guides concerning drug use during pregnancy 5.
Recommendations for Use
- Antacids, alginates, and sucralfate are the first-line therapeutic agents for treating heartburn during pregnancy, and if symptoms persist, any of the H2 RAs, including famotidine, can be used except for nizatidine 6.
- The management of heartburn during pregnancy and lactation begins with lifestyle modifications, and medical providers must discuss risks and benefits of these medicines with the patient in detail 6.
- The use of famotidine during pregnancy should be discussed with the primary physician if symptomatically necessary, and the benefits and risks of treatment should be carefully considered 2, 6, 3.