Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation The following tables summarize safety of drug use in pregnancy and lactation. Medications of herbal origin are excluded from the list. Under the column "Drug-Pregnancy Categories", letters A, B, C, D, and X signify the FDA Pregnancy categories. These five categories indicate the potential of a systemically-absorbed drug to cause birth defects; the key differentiation among the categories rests upon the reliability of documentation and the risk: benefit ratio. FDA Pregnancy Categories: A : Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote. B : Either animal-reproductive studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of risk in later trimesters. C : Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus. D : There is positive evidence of human fetal risk, but the benefit from use in pregnant women may be acceptable despite the risk (If the drug is needed for life threatening situations or for serious diseases for which safer drugs can not be used or are ineffective). X : Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Pharmacy & Therapeutic Committee- Sep 2018 Page 1 of 39 Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation For drugs not FDA approved; other classification systems were used to identify the pregnancy categories, whenever possible, the two other systems used are: 1. Micromedex Pregnancy Ratings: Fetal risk cannot be Available evidence is inconclusive or is inadequate for determining ruled out fetal risk when used in pregnant women or women of childbearing potential. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy. Fetal risk has been Evidence has demonstrated fetal abnormalities or risks when used demonstrated during pregnancy or in women of childbearing potential. An alternative to this drug should be prescribed during pregnancy or in women of childbearing potential. Fetal risk is minimal The weight of an adequate body of evidence suggests this drug poses minimal risk when used in pregnant women or women of childbearing potential. 2. Australian Drug Evaluation Committee (ADEC) Pregnancy Category Definitions 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. 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. 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. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. 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. Studies in animals have shown evidence of an increased occurrence of fetal damage, the Pharmacy & Therapeutic Committee- Sep 2018 Page 2 of 39 Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation significance of which is considered uncertain in humans. 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. These effects may be reversible. Accompanying texts should be consulted for further details. D : Drugs which have caused, are suspected to have caused, or may be expected to cause an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. X : Drugs that have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. Note: For drugs in the B1, B2 and B3 categories, human data are lacking or inadequate and sub- categorization is therefore based on available animal data. The allocation of a B category does not imply greater safety than the C category. Drugs in category D are not absolutely contraindicated in pregnancy (e.g. anticonvulsants). Moreover, in some cases the 'D' category has been assigned on the basis of 'suspicion'. If there was no data under the previous three categorizations, the drug-pregnancy category is assigned as "N/A" Data for medication use during breast feeding, are complied from FDA data, WHO data and Micromedex Lactation Ratings: 1. WHO Lactation Ratings: Avoid breastfeeding Avoid breastfeeding if possible. May inhibit lactation Avoid breastfeeding if possible. Monitor infant for side effects Compatible with breastfeeding Compatible with breastfeeding. Monitor infant for side effects WHO documentation states insufficient data 2. Micromedex Lactation Ratings: Infant risk cannot be Available evidence is inconclusive or is inadequate for determining ruled out fetal risk when used in pregnant women or women of childbearing potential. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding Pharmacy & Therapeutic Committee- Sep 2018 Page 3 of 39 Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation Infant risk has been Evidence and/or expert consensus has demonstrated harmful demonstrated infant effects when used during breastfeeding. An alternative to this drug should be prescribed or patients should be advised to discontinue breastfeeding. Infant risk is minimal The weight of an adequate body of evidence and/or expert consensus suggests this drug poses minimal risk to the infant when used during breastfeeding Milk effects are Evidence suggests this drug may alter milk production or possible composition. If an alternative to this drug is not prescribed, monitor the infant for adverse effects and/or adequate milk intake Abbreviations used in the tables: AAP: American Academy of Pediatrics APR: Australian Pregnancy Ratings FDA: U.S. Food and Drug Administration IU: International Unit N/A: no data available MLR: Micromedex Lactation Ratings MPR: Micromedex Pregnancy Ratings RDA: Recommended daily allowance WHO: World Health Organization Pharmacy & Therapeutic Committee- Sep 2018 Page 4 of 39 Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation Generic Name Pregnancy Category Breast Feeding Considerations Excretion in breast milk unknown/not Abatacept C recommended (Possible toxicity) Abiraterone X Not indicated for use in women Excretion in breast milk unknown/not Acarbose B recommended Acetaminophen [Paracetamol] C Excreted in breast milk/use caution Acetaminophen [Paracetamol] Refer to Individual Refer to Individual Agents and Codeine Agents Acetaminophen [Paracetamol] C Excreted in breast milk/not recommended and Codeine and Caffeine Acetaminophen [Paracetamol] C Excreted in breast milk/not recommended and Tramadol Acetazolamide C Excreted in breast milk/not recommended Excretion in breast milk unknown/use Acetic Acid C caution Excretion in breast milk unknown/use Acetylcysteine B caution Aciclovir [Acyclovir] (Systemic, B Excreted in breast milk/use caution Topical) MPR: Fetal risk Excretion in breast milk unknown/use Activated Charcoal cannot be ruled out caution Adalimumab B Excreted in breast milk/use caution Excretion in breast milk unknown/use Adapalene C caution Excretion in breast milk unknown/not Adefovir C recommended Excretion in breast milk unknown/not Adenosine C recommended Excretion in breast milk unknown/not Ado-Trastuzumab D recommended Aescin No data available No data available Excretion in breast milk unknown/not Aflibercept C recommended Agomelatine (P) ADEC*: B1 MLR: Infant risk cannot be ruled out Albendazole C Excreted in breast milk/use caution Albumin C MLR: Infant risk cannot be ruled out Excretion in breast milk unknown/use Alendronate C caution Alfacalcidol No data available Excreted in breast milk/not recommended Pharmacy & Therapeutic Committee- Sep 2018 Page 5 of 39 Department of Pharmaceutical Care Drug Use in Pregnancy & Lactation Generic Name Pregnancy Category Breast Feeding Considerations