Pregnancy Safety Ratings for Medications: Bismuth and Dicyclomine - Pharmacology

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Pregnancy Drug Categories


Hello, the doctor prescribed medication for my gastrointestinal discomfort, but I couldn't find the pregnancy category for two of the medications.
Could you please help me? Thank you! 1.
Bismuth tablet 324 mg 2.
Coochil (dicyclomine) 10 mg

Sabrina, 30~39 year old female. Ask Date: 2023/04/20

Dr. Wu Junhao reply Pharmacology


Hello, based on the drug information you inquired about, the pregnancy classifications are as follows:
1.
Bismuth tablet 324mg: B2 (AUS) - This medication has been used by a limited number of pregnant women and women of childbearing age, with no observed increase in the frequency of malformations or other direct or indirect harmful effects on human fetuses.
Animal studies are insufficient or may be lacking, but available data indicate no evidence of an increased incidence of fetal injury.
2.
Coochil (dicyclomine) 10mg: Fetal risk cannot be ruled out (MDX) - Current evidence is inconclusive or insufficient to determine the fetal risk associated with use during pregnancy.
This information is provided for your reference.
Thank you.
(Source: Micromedex®)

Reply Date: 2023/04/20

More Info


When it comes to the safety of medications during pregnancy, understanding the FDA pregnancy categories is crucial. The two medications you mentioned, Bismuth tablets and Dicyclomine (Coochil), have different safety profiles based on available research and clinical data.

1. Bismuth Tablets (324 mg): In Australia, Bismuth is classified as a Category B2 medication. This classification indicates that there is limited data on its use in pregnant women, but studies have not shown an increase in fetal malformations or other harmful effects on the human fetus. Animal studies are either insufficient or lacking, but available data suggest that there is no evidence of increased fetal injury. Bismuth compounds, such as Pepto-Bismol, are often used to treat gastrointestinal discomfort, including diarrhea and upset stomach. While the data is reassuring, it is always best to use caution and consult with your healthcare provider before taking any medication during pregnancy.

2. Dicyclomine (Coochil, 10 mg): Dicyclomine is classified as Category C by the FDA. This means that risk to the fetus cannot be ruled out. Animal studies may have shown adverse effects, but there are no well-controlled studies in pregnant women. Dicyclomine is an anticholinergic medication commonly used to treat irritable bowel syndrome and other gastrointestinal disorders. Given its Category C classification, it is essential to weigh the benefits against the potential risks when considering its use during pregnancy. If the medication is necessary for managing severe gastrointestinal symptoms, your healthcare provider may decide that the benefits outweigh the risks.


Additional Considerations
- Consultation with Healthcare Providers: It's crucial to have open communication with your healthcare provider about any medications you are taking or considering during pregnancy. They can provide personalized advice based on your medical history and the specifics of your pregnancy.

- Alternative Treatments: If there are concerns about the safety of these medications, your healthcare provider may suggest alternative treatments that are considered safer during pregnancy. Lifestyle modifications, dietary changes, and non-pharmacological interventions may also be effective in managing gastrointestinal discomfort.

- Monitoring and Follow-Up: If you have already taken these medications and are concerned about their effects, your healthcare provider may recommend additional monitoring, such as ultrasounds or other assessments, to ensure the well-being of you and your baby.

- General Advice for Pregnant Women: Pregnant women should always be cautious about taking any medications, including over-the-counter drugs and herbal supplements. It is advisable to avoid self-medication and to consult healthcare professionals for guidance.

In summary, while Bismuth tablets appear to have a relatively reassuring safety profile during pregnancy, Dicyclomine carries a potential risk that should be carefully considered. Always consult with your healthcare provider before starting or continuing any medication during pregnancy to ensure the best outcomes for both you and your baby.

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