Therapeutic Problems in Pregnancy

Using the trade name , find the active ingredient of the medicine in the Australian Register of therapeutic Goods. Find the Product Information or Consumer Medicine Information documents of many prescription medicines registered in Australia, searching for the trade name or active ingredient.

The substance in a medicine that is biologically active and which due to its pharmacological activity is responsible for producing the desired effect on the structure or function of the body. A name used to identify a commercial product or service. One generic medicine can have multiple commercial names. Decrease the text size Increase the text size Print this page Share. Related information Updates to the Prescribing medicines in pregnancy database.

The Australian categorisation system for prescribing medicines in pregnancy The Australian categorisation system and database for prescribing medicines in pregnancy have been developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. What does the Australian categorisation system take into account? The categorisation system has taken into account the known harmful effects of medicines on the developing baby, including the potential to cause: Situations for which the pregnancy category may not be valid The pregnancy categorisation system only applies to recommended therapeutic doses in women.

It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as: Overdose Occupational exposure Other situations in which the recommended therapeutic dose has been exceeded Why do some products have more than one pregnancy category? While some medicines are genuinely teratogenic, and carry a category X, for most medicines the risk of developing birth defects is also dependent on: Systemic exposure of the mother Exposure of the fetus, which may be affected by: Dose Route of administration Dosing regimen Thus, a low dose, limited topical application of a medicine for a particular indication may have a less restrictive category such as A compared to a more restrictive category for the same medicine given long-term or at higher doses orally for a different indication.

Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories Subcategorisation of the B category is based on animal data The allocation of a B category does not imply greater safety than a C category Medicines in category D are not absolutely contraindicated during pregnancy e. Definitions of the Australian categories for prescribing medicines in pregnancy Category A Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

Category B1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. Category B2 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Category B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Category C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations.

Or No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. D Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. X Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant. Open in a separate window. FDA categorization of drugs for use in pregnancy.

Drug Comments Vitamin A and its derivatives including isotretinein, accutane and etretinate. Significant risk of spontaneous abortion[ 20 ] and risk of many significant anomalies[ 21 ] ACE inhibitors May cause kidney damage in the fetus when used in II and III trimester, decrease in the amount of amniotic fluid and deformities of face, limbs and lungs[ 7 ] Anticoagulants- warfarin Use during I trimester produces defects like nasal hypoplasia and a depressed nasal bridge; termed as Fetal warfarin Syndrome.

Estrogen and Androgens Genital tract malformations[ 8 ]. Thyroid preparations- Methimazole Overactive and enlarged Thyroid gland Carbimazole Overactive and enlarged Thyroid gland Radioactive iodine Underactive Thyroid gland in fetus Propylthiouracil Safe[ 7 ]. Anticonvulsants- Carbamazepine Risk of birth defects Phenytoin, Phenobarbitone Bleeding problem in the newborn which can be prevented if pregnant woman takes Vit. K by mouth every day for a month before delivery or if the newborn baby is given an injection of Vit. K soon after birth[ 7 ]. Risk of birth defects. Trimethadione Increased risk of miscarriage in the women Sodium valproate Increased risk of birth defects in fetus; including a cleft palate and abnormalities of the heart, face, skull, hands or abdominal organs[ 7 ].

Antidepressants- Lithium Birth defects mainly of the heart , lethargy, decreased muscle tone, underactivity of Thyroid gland and nephrogenic diabetes insipidus in the new born. Ebstein's anomaly tricuspid valve malformation has been reported in a number of foetuses exposed to this drug[ 7 ]. NSAIDs Aspirin and other Salicylates Delay in start of labor, premature closing of ductus arteriosus, jaundice, brain damage in the fetus and bleeding problems in the woman during and after delivery and in the newborn[ 7 ].

Antibiotics- Tetracycline Slowed bone growth, permanent yellowing of the teeth and increased susceptibility to cavities in the body[ 7 ]. Chloramphenicol Gray Baby Syndrome[ 7 ]. Ciprofloxacin Possibility of joint abnormalities seen in animals [ 7 ] Kanamycin and Streptomycin Damage to fetus's ear resulting in deafness risk of ototoxicity [ 7 ] Sulfonamides Jaundice and brain damage in newborn[ 7 ] Antineoplastic agents- Busulfan Birth defects such as less than expected growth before birth, underdevelopment of lower jaw, cleft palate, abnormal development of skull bones, spinal defects, ear defects and club foot[ 7 ].

Chlorambucil Cyclophosphamide Methotrexate Oral Hypoglycemic drugs A very low level of sugar in the blood of newborn. Inadequate control of diabetes in the pregnant woman[ 7 ] Chlorpropamide Tolbutamide. SOCIAL DRUGS In addition to counseling pregnant women regarding use of various prescribed and non-prescribed medications during pregnancy, other substances that are also used by some women during pregnancy should not be overlooked. Footnotes Sachdeva, et al.: Risk and benefit of drug use during pregnancy.

PHYSIOLOGICAL CHANGES IN PREGNANCY

Int J Med Sci. Medications in pregnancy and lactation. Amer J Maternal Child Nursing. Take two Aspirin or not? Risk of medication use during pregnancy. Difficulties in the study of adverse fetal and neonatal effects of drug therapy during pregnancy. Mother and Child Glossary; [updated on Jul 9]. Maternal Physiology during Pregnancy. Current obstetrics and gynaecological diagnosis and treatment.

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Prescription drug use in pregnancy. Am J Obstet Gynaecol. Drugs in pregnancy and lactation. Splinter MY, Sagraves R. Prenatal use of medications by women giving birth at a university hospital. A study of drug utilization during pregnancy in the light of known risks. Int J Risk Safety Med. Drugs in Pregnancy and Lactation. Text book of Therapeutics, Drug and Disease Management. Obstetrics Handbook for Maternal Health. Niche Laboratories Ltd; Drug effects on the fetus and breastfed infants. Which medications are safe in pregnancy? Pregnancy and the drug dilemma. Koren G, Pastuszak A. N Eng J Med.

Support Center Support Center. Please review our privacy policy. Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and wellcontrolled studies in pregnant women. Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.

Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities.

Vitamin A and its derivatives including isotretinein, accutane and etretinate.

Significant risk of spontaneous abortion[ 20 ] and risk of many significant anomalies[ 21 ]. May cause kidney damage in the fetus when used in II and III trimester, decrease in the amount of amniotic fluid and deformities of face, limbs and lungs[ 7 ]. Use during I trimester produces defects like nasal hypoplasia and a depressed nasal bridge; termed as Fetal warfarin Syndrome.

Safe but if taken for long time osteoporosis and decrease in number of platelets in pregnant women occurs[ 7 ]. Genital tract malformations[ 8 ]. Bleeding problem in the newborn which can be prevented if pregnant woman takes Vit. Increased risk of birth defects in fetus; including a cleft palate and abnormalities of the heart, face, skull, hands or abdominal organs[ 7 ]. Pregnancy - medication, drugs and alcohol Share show more. Drugs and addictive behaviours Drugs - Drug issues througout life Drugs - Health effects of drugs Alcohol - Alcohol issues throughout life Healthy pregnancy - Keeping healthy during pregnancy Healthy pregnancy - Health concerns during pregnancy Healthy pregnancy.

Most women take a drug of some kind during pregnancy, often without realising the potential for harm. Give your doctor, midwife and pharmacist a list of all medications and drugs you take or have recently taken, including prescription and over-the-counter medicines, nutrition supplements, complementary therapies such as herbal medicine , social drugs such as alcohol and illegal drugs. Women with pre-existing medical conditions such as asthma, epilepsy or diabetes must continue treatment with the appropriate medications during pregnancy under supervision of a doctor.

Ask your doctor or midwife for advice or seek counselling if you need help to stop taking alcohol or other drugs. If you are concerned about your long-term medication, the doctor may, in some cases, be able to prescribe a similar medication that does not have any known effects on the fetus. Most women take some kind of drug, substance or medication during pregnancy, sometimes without realising the potential for harm.

Drugs or medication taken by the mother may cross the placenta and reach the developing fetus. The possible effects may include developmental delay, intellectual disability, birth defects miscarriage and stillbirth. You should always give your doctor, midwife and pharmacist a full list of all the medications you take, or have recently taken, including: You should also tell your doctor or midwife if you smoke, drink alcohol or take illegal drugs, even if you only take them occasionally or socially.

Effects of medication, drugs or substances during pregnancy Generally a drug, substance or medication can cause harm by: The potential for harm to the pregnancy and unborn baby depends on a range of factors including: Harmful drugs, substances and medications Some drugs, substances or medications may be harmful during pregnancy, depending on the amount and frequency of use. These unknown substances can also be harmful to the pregnancy or fetus. Birth defects and medicines taken during pregnancy The risk of a birth defect for any baby is about four per cent, regardless of the circumstances during pregnancy.

This means that even a woman who strictly avoids drugs and medications while pregnant may still have a baby with a birth defect. Most medicines are not harmful to a developing baby.

Teratogenic drugs and medicines Numerous drugs or drug groups may cause birth defects in a developing fetus, including: ACE angiotensin converting enzyme inhibitors used to treat high blood pressure or congestive heart failure angiotensin II antagonists, also used to treat high blood pressure or congestive heart failure Isotretinoin an acne drug alcohol cocaine high doses of vitamin A lithium male hormones some antibiotics some anticonvulsant medications some cancer-fighting medications some drugs that treat certain rheumatic conditions some thyroid medications Thalidomide the blood-thinning drug warfarin the hormone diethylstilbestrol DES.

This list is not complete. For example, the teratogenic effects of illegal drugs such as cannabis or amphetamines are not clear, because of the lack of medical studies. Pregnancy risk classification for medicines Medicines in Australia are given a risk category by the Australian Drug Evaluation Committee for drugs used in pregnancy, according to their safety information. This category applies only to recommended doses. A — medications that have been taken by a large number of pregnant women without any proven increase risk of birth defect B — medications that have been taken by only a limited number of pregnant women.

Human data is lacking and they are further categorised based on available data from animal studies B1 — animal studies have not shown any increased risk B2 — animal studies are limited, but there does not seem to be any increased risk B3 — animal studies show an increased risk, but it is not clear if this risk applies to humans C — medications that, due to their effects, may cause harm to the fetus without causing birth defects. These effects may be reversible D — drugs that have caused or may cause birth defects. However, the health benefit may outweigh the risk X — drugs that have a high risk of birth defects and should not be used during pregnancy.

See your doctor or pharmacist for further information and explanation. Medicines that may be necessary during pregnancy Good health in the mother is vital to ensure healthy development and growth of her unborn baby. Women with pre-existing medical conditions such as asthma, epilepsy, high blood pressure, thyroid conditions or diabetes must continue treatment with appropriate medications during pregnancy. Sometimes, a prescription medication has the potential to cause harm to the baby.

However, stopping the prescribed medication could also pose a threat to both the mother and her baby. If a pregnant woman who has asthma stops taking her medication, there is a risk of slowing the growth of her unborn baby. If a pregnant woman who has epilepsy stops her anti-epileptic medications, she may have an increased risk of having seizures, and complications to her pregnancy and unborn baby.

Poorly managed maternal diabetes increases the health risk for the unborn baby. In some cases, your doctor may be able to prescribe a similar medication that is considered safer to use during pregnancy. Illnesses such as an acute respiratory infection like pneumonia or complications during pregnancy such as pre-eclampsia may be treated with prescription drugs. Do not stop taking or alter the dose of a prescribed medicine without the knowledge and consent of your doctor. Untreated, some illnesses or pregnancy complications may risk the health of the mother or baby, or both.

Discuss any concerns you may have about medicines with your doctor or midwife. Smoking and alcohol during pregnancy Some pregnant women may be unaware that smoking and consuming alcohol and caffeinated drinks during pregnancy could risk the health of their unborn baby. Babies have a greater risk of low birth weight, prematurity and sudden unexpected death in infants SUDI.

However, heavy use greater than seven cups of coffee per day may be associated with an increased risk of low birth weight. Alcohol consumption during pregnancy Drinking alcohol during pregnancy has been associated with miscarriage, babies who are small for their gestational age and intellectual impairment in children known as fetal alcohol syndrome. No completely safe level of alcohol consumption has been determined for pregnant women. The National Health and Medical Research Council recommendations for women who are pregnant, or might soon become pregnant, are that: Not drinking alcohol is the safest option.

The risk of harm to the fetus is highest when there is high, frequent, maternal alcohol intake. The risk of harm to the fetus is likely to be low if a woman has consumed only small amounts of alcohol before she knew she was pregnant or during pregnancy. The level of risk to the individual fetus is influenced by maternal and fetal characteristics and is hard to predict. A standard drink contains 10 g of alcohol. Illegal drugs and pregnancy Since illegal drug use is a secretive activity, our knowledge on the effects of these drugs during pregnancy is limited. Substances with some known effects include: Drugs used to treat heroin and other opioid dependence Methadone and buprenorphine are prescription drugs, sometimes called pharmacotherapies.

They are used to help treat heroin and opioid dependency. The risks to the fetus and pregnancy associated with heroin use are greatly reduced with both of these treatments. The benefits of pharmacotherapy are reduced if you continue to use heroin or other drugs. Recommendations for use of medication, drugs and substances during pregnancy Be guided by your doctor, but general recommendations include: Limit yourself to less than mg of caffeine per day which roughly equates to one espresso-style coffee or two cups of instant coffee per day, or four cups of medium strength tea or hot chocolate per day, or six cups of cola per day.

See your doctor or seek drug counselling if you need help to quit smoking, alcohol or other drugs. Be advised by your doctor or pharmacist. Using alternatives to medications during pregnancy Whenever possible, use non-drug alternatives to manage minor health concerns during pregnancy. Avoid heartburn by eating small, frequent snacks rather than three large meals. Use salt-water nasal sprays to treat nasal congestion. Avoid foods or smells that trigger nausea. References National clinical guidelines for the management of drug use during pregnancy, birth and the early development years of the newborn, , NSW Department of Health, for Australian Government.

Clinical and Molecular Teratology, vol. Australian guidelines to reduce health risks from drinking alcohol, , National Health and Medical Research Council, Australian Government. American Journal of Obstetrics and Gynecology, vol. Send us your feedback. Rate this website Your comments Questions Your details.

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