From the FDA Drug Label
Pregnancy - Pregnancy Category C:Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed. The use of Tesselon Perles (hyoscyamine) during pregnancy is categorized as Pregnancy Category C. This means that animal reproduction studies have not been conducted, and it is not known whether hyoscyamine sulfate can cause fetal harm. Therefore, hyoscyamine sulfate should be given to a pregnant woman only if clearly needed 1.
From the Research
Tesselon Perles (hyoscyamine) should be avoided during pregnancy unless the potential benefits clearly outweigh the risks. This medication is classified as FDA Pregnancy Category C, which means that animal studies have shown adverse effects on the fetus, but there are no adequate well-controlled studies in humans 2. Hyoscyamine is an anticholinergic medication that can cross the placenta and potentially affect fetal development. Pregnant women should avoid using this medication, especially during the first trimester when organ development occurs.
Some studies suggest that medications should be employed with caution in women of childbearing age who are pregnant or considering pregnancy 3. The use of any medication during pregnancy carries a risk for teratogenicity and careful risk/benefit assessment should be done before prescribing them. Women are aware of general risks associated with medication use but are often unable to articulate specific negative outcomes, and they need specific information to help them make decisions about medication use during pregnancy 4.
In general, the use of over-the-counter drugs during pregnancy can result in placental transfer and accumulation of these drugs in the fetus, and may produce deleterious effects in the fetus but not the mother 5. If you are pregnant or planning to become pregnant and currently taking Tesselon Perles, you should consult with your healthcare provider immediately to discuss alternative treatment options. Your doctor may recommend safer alternatives to manage your symptoms based on your specific medical condition. The risks associated with hyoscyamine during pregnancy include potential effects on fetal heart rate, decreased fetal movement, and other developmental concerns, which is why caution is strongly advised.
Key considerations for the use of Tesselon Perles during pregnancy include:
- The potential benefits of the medication must clearly outweigh the risks
- Alternative treatment options should be considered
- Pregnant women should consult with their healthcare provider before taking any medication
- The use of any medication during pregnancy carries a risk for teratogenicity and careful risk/benefit assessment should be done before prescribing them.