Impact of Long-term Medication on Pregnancy: A Liver Health Perspective

Q: Impact of Long-term Medication on Pregnancy: A Liver Health Perspective

Hello, Xiao J： Thank you for your inquiry. <br>According to the drug package insert, Entecavir is classified as Category C for use during pregnancy, indicating that there are no adequate and well-controlled studies in pregnant women. <br>When pregnant rats and rabbits were admini

Liver medication consultation

Hello, Doctor.
I was diagnosed with elevated liver enzymes at the end of 2013.
I received interferon treatment to lower the enzyme levels, and due to high viral load, my doctor prescribed Baraclude (entecavir) for treatment.
I took it continuously for one year, then switched to the same class of medication, Viread (tenofovir), and continued for another year.
At the beginning of this year, my enzyme levels were normal, but my doctor did not mention stopping the medication, so I have been taking one pill daily until now.
I have been considering having a second child in the past few months.
I would like to know if long-term use of these medications could affect the fetus.
If I truly want to conceive, do I need to stop the medication for more than six months? Additionally, I have been taking antibiotics for enlarged tonsils this past week; could this medication also have an impact?

Xiao J, 30~39 year old female. Ask Date: 2016/03/03

Dr. Huang Shenggang reply Pharmacology

Hello, Xiao J: Thank you for your inquiry.
According to the drug package insert, Entecavir is classified as Category C for use during pregnancy, indicating that there are no adequate and well-controlled studies in pregnant women.
When pregnant rats and rabbits were administered Entecavir at doses equivalent to 28 times and 212 times the maximum human exposure levels, respectively, no evidence of embryotoxicity was observed.
However, since animal reproduction studies may not predict human responses, Entecavir should only be used during pregnancy if clearly needed and after careful consideration of the risks and benefits.
Embryotoxicity studies have been conducted in rats and rabbits.
When pregnant rats and rabbits were exposed to Entecavir at approximately 28 times (rats) and 212 times (rabbits) the maximum human exposure level (based on the maximum recommended human dose of 1 mg/day), no embryotoxic effects were noted.
In rats, maternal toxicity, embryonic-fetal toxicity (resorption), lower fetal weight, tail and spinal deformities, reduced ossification (in the spine, sternum, and phalanges), and additional lumbar and rib bones were observed when the maternal exposure was 3100 times that of humans.
In rabbits, when maternal exposure was 883 times that of humans, embryonic-fetal toxicity (resorption) and reduced ossification (of the hyoid bone) as well as an increased incidence of the 13th rib were noted.
In studies conducted at birth and postnatally, when the oral exposure dose of Entecavir in rats exceeded 94 times that of humans, no adverse reactions were observed in the offspring.
Currently, there are no adequate and well-controlled studies in pregnant women.
There have been no studies on labor and delivery in pregnant women, nor is there data on the effects of Entecavir on vertical transmission of HBV from mother to child.
Therefore, appropriate interventions should be taken to prevent neonatal HBV infection.
It is currently unclear whether Entecavir is excreted in human breast milk; however, it is known to be secreted in the milk of lactating rats.
Since many drugs are excreted into human breast milk and due to the potential for serious adverse reactions from Entecavir during breastfeeding, the decision to discontinue breastfeeding or to stop using Entecavir should be made after considering the importance of hepatitis B treatment for the mother and the known benefits of breastfeeding.
Drug interactions have been evaluated in vitro and in vivo regarding the metabolism of Entecavir.
Entecavir is not a substrate, inhibitor, or inducer of the cytochrome P450 (CYP450) enzyme system.
I am not sure which antibiotic you are taking, but you may consult your pharmacist when picking up your medication.

Reply Date: 2016/03/03

More Info

When considering the impact of long-term medication on pregnancy, particularly in the context of liver health, it is essential to evaluate both the specific medications involved and the overall health of the mother. In your case, you have been on antiviral medications for hepatitis B, specifically Entecavir (known as Baraclude) and Adefovir (known as Hepsera), which are commonly prescribed for managing chronic hepatitis B infection.

Impact of Antiviral Medications on Pregnancy
1. Entecavir (Baraclude): This medication is classified as Category C for pregnancy. This means that while animal studies have shown no evidence of harm to the fetus, there are no well-controlled studies in pregnant women. The decision to use Entecavir during pregnancy should be made only if the potential benefits justify the potential risks to the fetus. The available data suggest that at therapeutic doses, the risk of teratogenic effects is low, but caution is advised.

2. Adefovir (Hepsera): Similar to Entecavir, Adefovir is also classified as Category C. Animal studies have indicated potential risks, but human data is limited. The use of Adefovir during pregnancy should also be carefully considered, weighing the benefits against the risks.

3. General Recommendations: For women planning to conceive, it is generally recommended to discuss medication management with a healthcare provider. If possible, it is often advised to stop antiviral medications at least six months prior to attempting to conceive to minimize any potential risks to the fetus. However, if the mother’s health is at risk due to hepatitis B, the benefits of continuing treatment may outweigh the risks.

Considerations for Antibiotic Use
Regarding your recent use of antibiotics for tonsillitis, the impact of antibiotics on pregnancy varies widely depending on the specific antibiotic prescribed. Many antibiotics are considered safe during pregnancy, while others may pose risks. For example:
- Penicillins (like Amoxicillin): Generally considered safe during pregnancy.

- Macrolides (like Azithromycin): Also typically safe.

- Tetracyclines: Should be avoided as they can affect fetal development.

It is crucial to inform your healthcare provider about your pregnancy when being prescribed any medication, including antibiotics, to ensure that the chosen treatment is safe for both you and your developing baby.

Conclusion and Recommendations
In summary, while the long-term use of antiviral medications for hepatitis B can have implications for pregnancy, the specific risks depend on the medication and the individual health circumstances of the mother. It is essential to have an open dialogue with your healthcare provider about your desire to conceive and the medications you are currently taking. They may recommend monitoring your liver health closely and possibly adjusting your treatment plan as you approach pregnancy.

If you are considering pregnancy, it is advisable to have a thorough discussion with your hepatologist or a maternal-fetal medicine specialist. They can provide personalized recommendations based on your health status, the medications you are taking, and the latest research on their safety during pregnancy. Additionally, if you are currently on antibiotics, ensure that your healthcare provider is aware of your pregnancy to avoid any potential risks associated with those medications.

Similar Q&A

Impact of Liver Medication on Pregnancy: What to Know for a Healthy Baby

I would like to ask: My husband has been taking Hepatoprotective medication for a year and has switched to another liver support medication for 6-7 months (he is still taking it now). I am currently five weeks pregnant. What is the impact on the fetus, and is it safe for the chil...

Dr. Zhuang Zhijian reply Obstetrics and Gynecology
Hello, thank you for your question. I would like to respond to your inquiry and provide the following advice: In reality, it will not have an impact. If it were to affect sperm quality, it generally would not lead to deterioration or affect embryo implantation. Wishing you peace ...

Effects of Long-Term Medication Use During Pregnancy on Fetal Health

Hello doctor, I am currently 21 weeks pregnant. The doctor has prescribed Adalat 5 mg, 2 tablets per dose, and Ritodrine, 1 tablet per dose, to be taken every 6-8 hours. I would like to ask if long-term use of these medications will have any effects on the fetus?

Dr. Zhang Kunmin reply Obstetrics and Gynecology
Hello, the medication Adalat is used for the treatment of hypertension and angina, and it is classified as a Category C drug for use during pregnancy. Animal studies have shown adverse effects on the embryo, but there have been no studies conducted on pregnant women. Therefore, i...

Early Pregnancy: Dietary Concerns and Medication Safety

Hello Dr. Chuang: The first day of my last menstrual period was April 8, and I am currently about four weeks pregnant. During this time, I took an allergy medication that contained: Decadolone 0.5 mg, Tellwell, AlOH 334 mg, Prinate 3 mg, and Buclizine 25 mg. Will this affect my f...

Dr. Zhuang Zhijian reply Obstetrics and Gynecology
1. Taking it only once should not cause significant issues; it is recommended to minimize usage during this period. 2. It should be fine. 3. Currently, there are no research reports indicating that it is necessary to "stay away from the computer."

Long-Term Birth Control Pills: Do You Need Liver and Kidney Function Tests?

Hello Doctor: Due to having polycystic ovary syndrome, my doctor recommended that I purchase birth control pills to regulate my menstrual cycle. I have been taking the birth control pills for almost 2 years without stopping, and aside from experiencing migraine symptoms, I have n...

Dr. Zhang Kunmin reply Obstetrics and Gynecology
Hello, the common side effects of oral contraceptives include: headaches, dizziness, heavy or irregular menstrual bleeding, nausea, vomiting, edema, increased cervical mucus, cervical hypertrophy, increased appetite, weight gain, skin itching, acne, fatigue, depression, flushing,...