Small Class for Expectant Mothers | I used ofloxacin gel during pregnancy, what will happen to my baby?

A few days ago, an expectant mother came to the pharmacy consultation window for a consultation. She said that she had used ofloxacin gel to apply on the acne on her face many times in the early stages of her pregnancy. She had used it on and off for a long time. Now that she knew she was pregnant, she was very worried that it would affect her unborn baby.

Many people know that "ofloxacin" is almost a quinolone antibiotic when they see the word "ofloxacin". For example, moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin, norfloxacin, etc., are all quinolone antibiotics. Ofloxacin gel is an external preparation containing quinolone antibiotics, which is suitable for skin and soft tissue infections caused by sensitive bacteria, such as folliculitis, furuncle, impetigo, traumatic infection and eczema infection.

Antibacterial drugs should not be used casually, let alone by pregnant mothers! What should I do? Is it impossible to have a baby?

Don't worry, let Yaowa analyze it for you——

Learn about the classification of medication during pregnancy

In order to use drugs safely and rationally during pregnancy, many countries and regions have classified drugs according to the degree of harm they cause to the fetus and implemented a pregnancy drug classification system. The most authoritative is the five-level classification system developed by the U.S. Food and Drug Administration (FDA).

The FDA classifies drugs into five categories: A, B, C, D, and X, based on the level of harm they may cause to the fetus during pregnancy.

Category A: Controlled studies have shown no harm and the drug can be used safely by pregnant patients;

Category B: No evidence of harm to humans, use with caution when there is a clear indication;

Category C: Animal studies have shown that the drug is harmful to the fetus, or there are no controlled studies on pregnant women, or there are no studies on pregnant women and animals. It can only be used after weighing the benefits to pregnant women outweigh the risks to the fetus;

Category D: Harmful to the human fetus, avoid use, but use with caution under close observation when there is a clear indication for use and the benefits to the patient outweigh the possible risks;

Category X: Contraindicated during pregnancy.

Quinolone antibiotics are classified as Category C in the FDA's classification of drugs for use during pregnancy.

The instructions for use of domestic quinolone drugs (mainly referring to systemic medications, such as oral and intravenous medications) state that because the safety of the drug use in pregnant women cannot be ensured, it is prohibited for women who are pregnant or may become pregnant; it is also prohibited for breastfeeding women and minors under the age of 18. The harm to the fetus and adolescents is mainly the impact on muscle and bone development.

Therefore, it is not recommended for pregnant women or those who are already pregnant to use quinolone drugs.

What should I do if I use it accidentally?

If a pregnant mother accidentally uses quinolone drugs, does that mean she can no longer have the baby?

The answer is not necessarily!

The foreign document "Guidelines for Medication Use During Pregnancy and Lactation" clearly states that if a pregnant woman accidentally takes quinolone drugs in early pregnancy, there is no need to terminate the pregnancy, but a detailed ultrasound examination is required.

At the "9th China Forum on Drug-Induced Diseases and Safe Medication Use and Women and Children Forum" in 2017, a "21-year Special Survey on Quinolones in Pregnant Women's Safe Medication Use Consultation" was announced. The results of the survey showed that no adverse reactions to cartilage and joints were found in the babies born to 72 pregnant women who had used quinolones such as levofloxacin in early pregnancy. However, the safety evaluation of quinolones during pregnancy still requires large-scale follow-up investigations.

To summarize, quinolone drugs should not be used if you are planning to become pregnant or are already pregnant; if you are pregnant and have already used them, you need to stop taking the drugs, get checked, and observe.

As for the expectant mother who came for consultation as mentioned by Wen Shi, she was using the topical preparation ofloxacin gel. First, the topical dosage was small; second, the medication was used intermittently, not continuously in large quantities, and the amount entering the body was very small, so the expectant mother should relax and not worry too much, but still insist on regular prenatal checkups. If necessary, she can go to the hospital's prenatal diagnosis center for further examination and consultation.

Be cautious when taking medications during pregnancy. Read the drug instructions carefully or consult a doctor or pharmacist before taking the medication, and keep a happy mood!

Author: Liu Minmin, Chief Pharmacist of the Pharmacy Department of Huizhou Second Maternal and Child Health Hospital

Review expert: Ren Yanli, chief pharmacist of the Gynecology and Pediatrics Group of the Henan Pharmaceutical Association Hospital

Wei Guoyi, Chief Pharmacist, Beijing Anzhen Hospital, Capital Medical University