Pregnancy and Medication: Assessing Risks of Common Gastro Drugs

Medications during pregnancy

Hello, doctor! My wife was unaware that she was pregnant and experienced stomach discomfort, so she went to a gastroenterology clinic and took medication for three days.
After three days, she returned for a follow-up and was prescribed more medication but only took one packet.
Feeling something was off, she took a pregnancy test and found out she was pregnant.
She immediately went to an obstetrics and gynecology clinic, where a transvaginal ultrasound showed she was 5 weeks and 4 days along, but there was only a gestational sac without a heartbeat.
The obstetrician advised us to return in a week to check for a heartbeat.
After a week, an abdominal ultrasound detected a heartbeat.

I would like to ask if the following medications could have a significant impact on the fetus:
1.
Aluzane Tablets - Ingredients: Oxethazaine, Polymagal
2.
Suwell Tablets "Everest" - Ingredients: Aluminum Hydroxide Dried Gel, Magnesium Hydroxide, Simethicone (Active Dimethicone)
3.
Promeran F.C.
Tablets 3.84mg - Ingredients: Metoclopramide (HCl H2O)
4.
Ulstop F.C.
Tablets 20mg "C.H." (Famotidine) - Ingredients: Famotidine
5.
Spasmotin Tablets “Sinphar” - Ingredients: Hyoscyamine Sulfate
The above medications were taken continuously for three days, and the following medications were taken for one packet:
6.
Aluzane Tablets - Ingredients: Oxethazaine, Polymagal
7.
Ulstop F.C.
Tablets 20mg "C.H." (Famotidine) - Ingredients: Famotidine
8.
Spasmotin Tablets “Sinphar” - Ingredients: Hyoscyamine Sulfate
9.
Dosin Tablets 10mg - Ingredients: Domperidone
10.
Fucole Paran Tablets - Ingredients: Acetaminophen (Equivalent to Paracetamol)
11.
Stomaccus - Indication: Gastrointestinal medication; I could not find information on this medication.
I am very concerned about whether these ingredients could affect the fetus.
I am worried about the possibility of D or X category drugs and their potential impact on the fetus!
- 2018/11/17 to 11/19: Took gastroenterology medication for three days
- 2018/11/19: Took one packet of gastroenterology medication
- 2018/11/19: Transvaginal ultrasound showed approximately 5 weeks and 4 days with no heartbeat
- 2018/11/29: Abdominal ultrasound showed approximately 7 weeks and 5 days with a heartbeat.

Zhang, 30~39 year old female. Ask Date: 2019/01/10

Dr. Zhang Kunmin reply Obstetrics and Gynecology

Hello, the pregnancy medication categories for the mentioned drugs are as follows:
- ALUZAINE TABLETS: Unknown
- SUWELL: Category C
- METOCLOPRAMIDE: Category B
- FAMOTIDINE: Category B
- HYOSCYAMINE: Category C
- DOMPERIDONE: Category C
- FUCOLE: Category B
- STOMACCUS: Not available
Category A: These medications have no risk of teratogenic effects and are considered safe.
They have been studied in controlled trials involving humans, and the potential harm to the fetus is minimal.
Vitamins fall into this category.
There are very few medications in this category, and research involving pregnant women is rare.
Category B: Animal studies indicate no risk to the fetus, but controlled studies in pregnant women have not been conducted.
Some animal studies show adverse effects on the fetus, but controlled studies in pregnant women have not confirmed harm to the fetus.
Common medications in this category include acetaminophen (the active ingredient in Tylenol).
Category C: Animal studies indicate adverse effects on the fetus, but controlled studies in pregnant women have not been conducted.
Some medications have not undergone animal or human trials.
Medications in this category should only be used if the potential benefits to the fetus outweigh the potential risks based on clinical judgment.
Caution is advised when using antipsychotic medications such as Lorazepam and Haloperidol.
Category D: There is sufficient evidence showing risk to the fetus, but if the benefits to the pregnant woman are deemed significant, these medications may be used despite the risks to the fetus.
Examples include antiepileptic drugs such as Carbamazepine and Phenytoin.
Category X: Both animal and human studies indicate that these medications can cause fetal abnormalities and pose a risk to the fetus.
These medications are absolutely contraindicated in pregnant women.
Examples include isotretinoin (for acne), thalidomide, and certain cholesterol-lowering medications.
Categories A and B are generally considered safe, while Category C poses more challenges due to insufficient human trial evidence, making it difficult for physicians to provide specific recommendations based on the risks the pregnant woman is willing to accept.
Generally, there are few reported cases of side effects from medications taken by pregnant women.
It is advisable to discuss any unknown or unverified medications with the prescribing physician and the obstetrician.
Thank you! Wishing you safety and health.
Dr.
Zhang

Reply Date: 2019/01/10

More Info

When it comes to medication during pregnancy, it is crucial to understand the potential risks and classifications of various drugs. The FDA categorizes medications into five categories (A, B, C, D, and X) based on their safety for use during pregnancy. Here’s a breakdown of the medications you mentioned and their potential effects on the fetus.

1. Aluzine Tablets (Oxethazaine, Polymag): Oxethazaine is a local anesthetic used to relieve pain in the gastrointestinal tract. It is classified as Category C, which means that while animal studies may show adverse effects, there are no adequate and well-controlled studies in pregnant women. Therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.

2. SuWell Tablets (Aluminum Hydroxide, Magnesium Hydroxide, Simethicone): This combination is generally used as an antacid and is considered relatively safe during pregnancy. Aluminum hydroxide and magnesium hydroxide are classified as Category B, indicating that they have not shown any risk in human studies. Simethicone, which helps relieve gas, is also considered safe.

3. Promeran F.C. Tablets (Metoclopramide): Metoclopramide is used to treat nausea and gastroparesis. It is classified as Category B, meaning it has not shown any risk to the fetus in human studies. However, it should still be used with caution and under medical supervision.

4. ULSTOP F.C. Tablets (Famotidine): Famotidine is a histamine-2 blocker used to reduce stomach acid. It is classified as Category B, indicating that it is generally considered safe during pregnancy.

5. Spasmotin Tablets (Hyoscyamine Sulfate): Hyoscyamine is an anticholinergic used to treat various gastrointestinal disorders. It is classified as Category C, meaning that while there may be some risks, it can be used if the benefits outweigh the risks.

6. Dosin Tablets (Domperidone): Domperidone is used to treat nausea and vomiting. It is classified as Category C, indicating that its safety during pregnancy has not been established.

7. FUCOLE PARAN Tablets (Acetaminophen): Acetaminophen is widely used for pain relief and is classified as Category B, making it one of the safer options for pain management during pregnancy.

8. STOMACCUS: Unfortunately, without specific information on the active ingredients, it's difficult to assess its safety. However, it is advisable to consult with a healthcare provider regarding any unknown medications.

In summary, the majority of the medications you mentioned fall into Category B or C, which means they are generally considered safe or can be used with caution during pregnancy. The key is to always consult with a healthcare provider before taking any medication, especially during pregnancy, to ensure that the benefits outweigh any potential risks.
Given that you are now approximately 7 weeks and 5 days pregnant and have confirmed a heartbeat, it is essential to continue monitoring your health and that of your baby. If you have any concerns about the medications taken during the early weeks of pregnancy, discussing them with your obstetrician or a maternal-fetal medicine specialist would be prudent. They can provide personalized advice based on your specific situation and health history.

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