From the FDA Drug Label
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Bentyl (dicyclomine) safety during pregnancy:
- The FDA drug label indicates that Bentyl is classified as Pregnancy Category B, meaning that adequate and well-controlled studies have not been conducted in pregnant women at the recommended doses.
- However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.
- Reproduction studies in rats and rabbits revealed no evidence of harm to the fetus due to dicyclomine.
- The drug label states that this drug should be used during pregnancy only if clearly needed 1.
- Therefore, Bentyl may be used during pregnancy if clearly needed, but it is essential to weigh the potential benefits against the potential risks.
From the Research
Bentyl (dicyclomine) is generally not recommended during pregnancy, especially during the first trimester, due to the lack of well-controlled studies in pregnant women and its potential anticholinergic effects on the developing fetus. The medication works by relaxing smooth muscles in the digestive tract to reduce spasms, but this effect could potentially affect the fetus. According to a study published in 2019 2, first-trimester exposure to certain medications has been associated with an increased risk of major congenital malformations, highlighting the need for caution when prescribing medications during pregnancy.
If you're pregnant and experiencing digestive issues like irritable bowel syndrome (IBS) that would typically be treated with Bentyl, you should consult your healthcare provider about safer alternatives. They may recommend lifestyle modifications (dietary changes, stress management), or medications with better established safety profiles during pregnancy, such as acetaminophen, which is generally considered safe during any trimester 3.
Some studies have investigated the safety of medications during pregnancy, including a meta-analysis of epidemiologic studies on Bendectin (Doxylamine/Dicyclomine/Pyridoxine) 4, which found no difference in the risk of birth defects between those infants whose mothers had taken Bendectin during the first trimester of pregnancy and those infants whose mothers had not. However, another study published in 2013 5 highlighted the critical gaps in information about fetal risk for many medications commonly used during pregnancy, emphasizing the need for careful consideration and consultation with a healthcare provider when making treatment decisions.
Key considerations for pregnant women taking Bentyl include:
- The potential risks of untreated severe symptoms versus medication exposure
- The need for careful weighing of benefits and risks on an individual basis
- The importance of consulting a healthcare provider to discuss specific situations and develop an appropriate treatment plan
- The availability of safer alternative treatments, such as lifestyle modifications or medications with better established safety profiles during pregnancy.