On October 10, to commemorate ‘Pregnant Women’s Day’, the Ministry of Food and Drug Safety (led by Director Oh Yu-kyung) in conjunction with the Korea Institute of Drug Safety and Risk Management (led by Director Son Soo-jung) announced the revision and publication of the “Safe Use of Medicines for Pregnant Women Guidebook (for Professionals)” to assist in the safe use of medication during pregnancy.
This revised edition is a practical guide compiling the latest medication approvals and treatment guidelines for experts such as doctors and pharmacists to use in medical settings, ensuring pregnant women and their families can receive safer treatment.
The information book includes the pharmacological characteristics of drugs used by pregnant women, drug therapy for major diseases, and domestic approval details. It also covers safe medication choices for common symptoms experienced during pregnancy, such as colds, morning sickness, constipation, and heartburn. Moreover, it provides the latest safety information on recently popular medications like obesity treatments, and offers guidance on adjusting medication for women with chronic conditions such as hypertension, heart disease, and thyroid issues when they plan to become pregnant.
The revised edition thoroughly details the latest safety information for 250 commonly used drug components for pregnant women. It includes tables on the efficacy, dosage, and precautions for each ingredient, enabling medical professionals to easily reference them during patient consultations or drug guidance.
The Ministry of Food and Drug Safety explained that the effects and risks of drugs during pregnancy vary according to physiological changes over time. During pregnancy, the increase in plasma volume, cardiac output, and uterine blood flow affects the absorption, distribution, metabolism, and excretion of drugs, so comprehensive consideration of the administration timing, dosage, and duration is necessary.
Detailed precautions for the use of medications for major symptoms are also provided. Rest and fluid intake are primarily recommended for cold or fever symptoms, but if a fever over 38 degrees persists, acetaminophen-based antipyretics may be taken. For a runny or stuffy nose, medications with cetirizine or chlorpheniramine can be used, and for coughing, dextromethorphan-based medications are available.
To relieve headaches or pain, acetaminophen can be taken, but the daily intake should not exceed 4,000 mg. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen should be used in minimum doses only between 20-30 weeks of pregnancy and avoided after 30 weeks.
For constipation, adequate fluid intake and lifestyle adjustments are prioritized, but if symptoms persist, medications containing lactulose or ispaghula can be taken.
Additionally, diet supplements intended for weight loss during pregnancy are prohibited. Particularly, medications containing topiramate should be avoided as they can cause fetal malformations.
The Ministry emphasized that “the use of drugs during pregnancy should be decided only after consultation with experts such as doctors or pharmacists,” stressing the importance of thoroughly reviewing the efficacy and risk of medications due to their direct impact on the health of the mother and fetus.
This revised guidebook is available for review on the Ministry of Food and Drug Safety’s main website under ‘Legal Information > Data Room > Guides’ or on the Korea Institute of Drug Safety and Risk Management’s website under ‘Education and Promotion > Data Room’.
Lastly, the Ministry expressed its hope that this guidebook will help ensure the safe use of medications by pregnant women in medical practice, assisting pharmaceutical professionals in providing accurate drug guidance based on the latest information. The Ministry promised to continue providing safety information to protect the health of pregnant women and their babies.