What Are the Effects of Taking Ibuprofen in Pregnancy?

Fetal malformations often result from genetic factors, as any distortion is accompanied by chromosomal changes. But a considerable number of malformations are due to poor medication during pregnancy. Many drugs and their metabolites can be teratogens, but not every teratogen can cause fetal malformations. Malformations can be manifested not only in the morphology and structure of various tissues and organs, but also in physiological functions, biochemical reactions, and behavioral activities. Although due to the characteristics of fetal development at different stages of pregnancy, the preparation of drugs also varies, but in general, the first three months of pregnancy due to fertilized eggs are in the stage of sequential differentiation, the systems have not been fully formed, at this time pregnant women Medication is easy to affect and cause fetal malformations.

Fetal malformations often result from genetic factors, as any distortion is accompanied by chromosomal changes. But a considerable number of malformations are due to poor medication during pregnancy. Many drugs and their metabolites can be teratogens, but not every teratogen can cause fetal malformations. Malformations can be manifested not only in the morphology and structure of various tissues and organs, but also in physiological functions, biochemical reactions, and behavioral activities. Although due to the characteristics of fetal development at different stages of pregnancy, the preparation of drugs also varies, but in general, the first three months of pregnancy due to fertilized eggs are in the stage of sequential differentiation, the systems have not been fully formed, at this time pregnant women Medication is easy to affect and cause fetal malformations.

The US Food and Drug Administration (FDA) classifies drugs into A, B, C, D, and X categories according to the effects of animal experiments and clinical experience on fetal teratogenesis.

The safety of medications during pregnancy for mothers and children has always been of concern to doctors and pregnant women. It is inevitable that pregnant women do not use drugs during pregnancy. According to statistics, up to 80% of women use drugs during pregnancy, so not only obstetricians and gynecologists, but also internal and external surgeons should know whether the drugs commonly used in each department can be used during pregnancy and how use.

FDA FDA pregnancy drug classification

Helps doctors prescribe safe medications for pregnant women based on the US Food and Drug Administration's (FDA) drug pregnancy risk classification.

FDA 5 FDA pregnancy drug classification

There are several ways to classify the drug safety for pregnant women during pregnancy. Among them, the standards formulated by the US Food and Drug Administration (FDA) are clear, scientific and objective, so they are widely accepted by doctors in various countries. The FDA divides the safety of drugs into five categories: A, B, C, D, and X. Some drugs have two different risk levels, one is a commonly used dose level, and the other is an extraordinary dose level. ^[1]

1.Class A

In a drug study with a control group, women in the first 3 months of pregnancy did not see any signs of harm to the fetus (and there was no evidence of harm in the next 6 months). Little impact. ^[2]

There are very few drugs classified as Class A. Vitamins belong to this class of drugs, such as various vitamins B and C, but vitamin A in the normal range is a class A drug, while large doses of vitamin A have a daily dose of 20,000 IU. Can be teratogenic and become class X drugs.

2.Class B

In animal reproduction studies (no controlled studies of pregnant women), no adverse effects of the drug on the fetus have been seen. Or, side effects of the drug were found in animal reproductive studies, but these side effects have not been confirmed in control women in the first 3 months of pregnancy (and there is no evidence of harm in the next 6 months).

There are not many drugs in category B. The good news is that antibiotics for daily use fall into this category. For example, all penicillin families and most cephalosporins are Class B drugs. Ampicillin, cefradine, ceftriazine, and ceftazidime for rescue in severe infections are all Class B drugs. In addition, jiemycin, clindamycin, erythromycin, and furantoin are also Class B drugs.

It is well known that metronidazole is a medicine for treating trichomoniasis, but it is also an excellent medicine for treating anaerobic infections. Although it can be teratogenic to rodents in animal experiments, a large amount of clinical data accumulated for a long time in humans has proven that although applied in early pregnancy, metronidazole did not increase the teratogenicity of the fetus. Therefore metronidazole is placed in class B in the F DA pregnancy drug classification.

Among anti-tuberculosis drugs, ethambutol is a Class B drug. Among the commonly used antipyretic and analgesics, indosucin, diclofenac, and ibuprofen are all class B drugs. However, it should be noted that after 32 weeks of pregnancy, taking indosucin may cause arterial narrowing or occlusion of the fetus, which may cause fetal death. Therefore, indosucin should not be taken after 32 weeks. ^[1]

Among the cardiovascular system drugs, digitalis, digoxin, and saponin are all class B drugs. Prednisone, a corticosteroid that is harmful to the fetus, is also a Class B drug.

3.Class C

Animal studies have proven that the drug is harmful to the fetus (teratogenic or embryonic death, etc.), or there have not been controlled pregnant women, or pregnant women and animals. This class of drugs should only be used after weighing the benefits to the pregnant woman over the harm to the fetus.

Class C drugs are more common. This class of drugs has not been available for a long time or is rarely used in pregnant women. It has not been reported whether early pregnancy can cause damage to the fetus, so it is difficult to draw a more accurate conclusion. Take the antibiotic quinolone as an example. Of these drugs, ofloxacin has been found to cause osteochondral damage in animal experiments. In humans, more than 600 cases of taking this drug in early pregnancy have been reported. There were 6 cases with pain in the legs, etc., but the symptoms disappeared shortly afterwards, none of which left sequelae, so the argument of this data is still safe. However, clinical reports still have to wait for more reports to confirm its harmlessness.

Be cautious about the use of Class C drugs. If there is a drug that can be replaced, use an alternative drug. Otherwise, after weighing the advantages and disadvantages, explain to the patient or the patient's family the reasons for choosing the drug. Take tuberculosis as an example: since only commonly used antituberculosis drugs are ethambutol, a type B drug, and antituberculosis treatment is often combined with several drugs, it is necessary to consider the application of C drugs such as sodium aminosalicylate and isoniazid. Medicine, if the patient is in early pregnancy with tuberculosis, the patient should be informed.

Most antiviral drugs belong to the C category, such as acyclovir, acyclovir and zidovudine for the treatment of AIDs. Some anti-epileptic drugs and sedatives such as ethosuximide, non-amylester, barbiturate, pentobarbital, etc. Among the autonomic nervous system drugs, choline-like drugs and anticholinergics are all in category C; as for some epinephrine-like drugs, they are in category C, such as epinephrine, ephedrine, and dopamine. Methyldopa, prazosin, and all commonly used vasodilators in antihypertensive drugs, such as phenantramine, an azozoline, and pentaerythritol, are all class C drugs, furiamide and mannitol in diuretics All are Class C drugs. Among the adrenal corticosteroids, betamethasone and dexamethasone are both class C drugs.

4.Class D

There is clear evidence that the drug is harmful to the human fetus, but nevertheless, pregnant women are definitely beneficial after taking the drug (such as using the drug to save the life of the pregnant woman or treating serious diseases that are not effective with other safer drugs).

Due to the experimental and clinical evidence, drugs classified as D are not used as much as possible during pregnancy, especially during early pregnancy. The tetracycline family is typical among antibiotics. Tetracycline or oxytetracycline is used during pregnancy, which destroys the fetal tooth enamel and turns yellow teeth in adults. This is the consequence of using tetracycline family drugs. Aminoglycosides are not used during pregnancy as much as possible, such as streptomycin. They may damage the eighth pair of cranial nerves and cause hearing loss.

As for antitumor drugs, they are almost all Class D drugs. Taking methotrexate as an example, in the late 1940s, people realized that the use of MTX in leukemia with pregnancy can cause villus necrosis and cause miscarriage, so Hertz in the early 50s After the germination of the idea of using MTX to treat choriocarcinoma and success, MTX has been widely used to treat diseases related to trophoblasts, such as ectopic pregnancy, placenta implantation, etc .; other anti-tumor drugs such as cisplatin, Fluorouracil and others have joined the ranks. Therefore, anti-tumor drugs are contraindicated during pregnancy.

Among the central nervous system drugs, analgesics are used in small doses, and in large doses, they are classified as D, especially for long-term use, which is harmful to the fetus. The main manifestations are fetal dysplasia and drug addiction after delivery Sex, irritability, crying, etc. Many of the antiepileptic drugs are Class D drugs. For example, epileptic ketones and trimethionone have teratogenic effects. It should be noted that the rate of malformation of the fetus after pregnancy in epilepsy patients is higher than that of the general population. Medicine can increase the distortion rate, especially when several anti-epileptic drugs are applied to difficult-to-control seizures, it also increases the fetal distortion rate. This is necessary to explain to patients and their families when diagnosing and treating epilepsy with pregnancy.

Diazepam, clozazol, meprobamate, and norhydroxylazepam are sedatives and hypnotics. They are all Class D drugs. If pregnant women have early pregnancy reactions and insomnia during early pregnancy, they cannot be given.

Among the diuretics, hydrochlorothiazide, itanilic acid, and benzeprazine are all class D drugs, and they should not be used during pregnancy. As for the antipyretic and analgesics, aspirin, salicylic acid and sodium salicylate are Class C drugs when used in small doses, but sometimes they are even addictive when taken in large doses for a long time, which is not good for the fetus and becomes a Class D drug.

In fact, there are tens of thousands of drugs available for people to use, and there are B, C, and D drugs in various drugs, so people can choose either B drugs or C drugs instead of D drugs. .

5.X grade

Drug research on animals and humans or human experience shows that drugs are harmful to the fetus, and that pregnant women are not benefited from using these drugs, so they are contraindicated in pregnant or likely pregnant patients.

There are not many such drugs in common drugs, but because of high teratogenicity or great harm to the fetus, it is contraindicated in the pre-pregnancy period and during pregnancy. The most famous of these is thalidomide (thalidomide, reaction stop). Women in the late 1950s and early 1960s near the European Union station took this medicine during the first trimester to reduce the pregnancy response, and later found many The fetus was born with short upper limbs, and its lower limbs merged into a seal-like shape, so it was called a seal-like malformation, which is a class X drug that people have known in earlier times. Diethylstilbestrol, a sex hormone commonly used in the past, was used to treat threatened abortion in the early 1950s. It was found that offspring women can develop vaginal adenopathy or clear vaginal cell carcinoma between the ages of 6 and 26. It is serious, so it belongs to class X medicine. These are two well-known cases of drug teratogenicity.

Vitamin A can be teratogenic in large doses and is also a class X drug. Vitamin A derivative retinoic acid is a drug for treating skin diseases and is also a class X drug. However, it is often neglected that people drink a lot of alcohol, such as drinking a lot during early pregnancy, ingesting a large amount of ethanol, 150mL or more a day can cause fetal dysplasia or malformation. Therefore, alcohol in the FDA classification is less classified as Class D, and higher amounts are classified as Class X. In addition, sedatives fluoxetine and flunazepam are both class X drugs, and the antineoplastic drug aminopterin is also a class X drug.

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FDA pregnancy drug classification

1. Drugs used during pregnancy. Avoid multiple drug prescriptions and choose Class B drugs whenever possible.

2. Don't just think about medication, you should focus on disease, because disease can bring more danger to mother and fetus.

3. Not only drugs can cause teratogenicity, but also pay attention to other possibilities of teratogenicity. Patients should be explained carefully when using the drug.

4. It should be noted that early pregnancy is the stage of differentiation of fetal body parts and organs. Teratogenicity of drugs is likely to occur at this stage. The safety of medications for intermediate and late pregnancy increases, but certain drugs, such as ethanol, are particularly harmful to the fetus The nervous system runs through the entire pregnancy. ^[4]

FDA FDA pregnancy drug classification

Medications without a pregnancy rating are not meant to be completely safe for pregnant women. You should refer to the "Medications for pregnant and lactating women" section of the complete drug information. For example, most topical drugs are not classified during pregnancy because, in general, only small amounts of topical drugs can be absorbed into the body transdermally. However, if a topical drug is used over a long period of time, the drug content in the body will increase. ^[2]

Other Chinese medicinal materials, proprietary Chinese medicines, and decoction pieces also have no pregnancy classification, but they must also be paid enough attention during pregnancy. ^[5-6]

FDA FDA pregnancy drug grading

Recently, the United States Food and Drug Administration (FDA) issued a rule that prescription drug labels should more clearly clarify the risks of taking drugs for pregnant and lactating women. As part of the reform, letters are no longer used to describe risk.

Current drug safety labels are terrible for pregnant and lactating women, causing physicians to look for relevant risk information from other sources.

Beginning in 2008, the program's new rules will replace some of the current labels labeled "pregnancy," "birth," and "lactation" with "pregnancy." Reproductive possibilities for men and women discusses information about pregnancy tests, birth control, and medications that can affect fertility. Although this information can be found on the label, it is very casual. Kweder thinks this information is hard to find and should be put together.

New pregnancy and breastfeeding will consist of three parts: risk summary, clinical considerations, and data. These will provide prescribers with more detailed information on human and animal studies, adverse events, and information on dosage adjustments during and after pregnancy. The new labeling requirements (not applicable to over-the-counter drugs) will take effect on June 30, 2015. After that, FDA-approved prescription drugs and biologicals must immediately use the new format for drug manufacturers. For previously approved drugs, manufacturers must gradually bring them into compliance within the next few years. ^[7]