Drug Use in Pregnancy & Lactation Flashcards
What lab result determines pregnancy?
A positive human chorionic gonadotropin (hCG+) lab result confirms pregnancy
What typically happens during the first trimester?
The first trimester (0-12 weeks) is when most organ development occurs, making the embryo most susceptible to birth defects caused by teratogens during this time
What should be done to teratogenic drugs?
For a drug to be teratogenic, the drug has to cross placenta into the fetal circulation. Teratogenic drugs should be discontinued prior to pregnancy, if possible
What organization publishes guidelines for safe and effective drug use in conditions impacting women, including pregnancy?
The American College of Obstetricians and Gynecologists (ACOG)
What are some lifestyle management strategies to recommend to pregnant women?
This includes encouragement to stop using illicit drugs, alcohol and tobacco, each of which is teratogenic. Behavioral intervention is a safe and sometimes effective strategy for prenatal smoking cessation
What can folate deficiency cause?
Folate deficiency causes birth defects of the brain and spinal cord (neural tube defects)
What is the recommended folate requirement during pregnancy?
During pregnancy, folate requirements increase to 600 mcg DFE/day. Females of childbearing potential should increase their folic acid consumption from a combination of dietary supplements, fortified foods and their regular diet
What is the dangers of vitamin deficiency?
If deficient in calcium, the mother’s bone health will be sacrificed to provide for the baby
What is the calcium and vitamin D requirement for pregnant women?
Pregnant women from 19-50 years old require 1000 mg/day of calcium and 15 mcg/day (600 IU/day) of vitamin D
What is the interpretation of pregnancy category A?
Controlled studies in animals & women show no risk in the first trimester. Risk of fetal harm is remote
What is the interpretation of pregnancy category B?
Animal studies have not demonstrated a fetal risk, but no well-controlled studies are available in pregnant women
What is the interpretation of pregnancy category C?
Animal studies have shown harm to the fetus, but there are no well-controlled studies in pregnant women. Use only if potential benefit outweighs the risk
What is the interpretation of pregnancy category D?
Positive evidence of risk to the human fetus is available, but the benefits may outweigh the risk with life-threatening or serious diseases
What is the interpretation of pregnancy category X?
Studies in animals or humans show fetal abnormalities. The risks involved clearly outweigh potential benefits; use in pregnancy is contraindicated
What is required for the pregnancy section in package inserts?
A pregnancy risk summary is required for all medications that includes the risk of adverse developmental outcomes based on human and animal data and the drug’s pharmacology. Includes any dose adjustments, maternal/fetal adverse reactions and disease risks
Why should pregnant women be encouraged to participate in registries?
Pregnant women should be encouraged to participate in registries, which exist for select disease states and drugs. The registries collect health information from women who take prescription drugs and vaccines when pregnant and breastfeeding. Information is also collected on the newborn baby
What does the lactation section in package inserts include?
Includes whether the drug/metabolites are present in human milk, the effects on the breastfed infant, and the effects on milk production. If applicable, ways to minimize exposure and monitor for adverse reactions are included
What does the females & males of reproductive potential in package inserts include?
Includes any effects on fertility and requirements for pregnancy testing and contraception
What are the two immunizations are routinely recommended for pregnant patients?
The inactivated influenza vaccine is recommended during any trimester at the beginning of flu season. A single dose of Tdap should be administered during each pregnancy.
*All live vaccines are contraindicated in pregnant patients
What are key drugs that are teratogenic?
- Acne: isotretinoin, topical retinoids
- Antibiotics: quinolones, tetracyclines
- Anticoagulants: Warfarin
- Dyslipidemia, Heart Failure and HTN: Statins, RASS inhibitors
- Hormones: Most, including estradiol, progesterone, raloxifene, Duavee, testosterone, contraceptivees
- Migraine: dihydroergotamine, ergotamine
- Others: Hydroxyurea, Lithium, Methotrexate, Misoprostol, NSAIDs, Paroxetine, Ribavarin, Thalidomide, Topiramate, Weight Loss drugs, Valproic Acid/Divalproex
What does USP Chapter 800 say about teratogens?
Teratogens are hazardous drugs according to USP Chapter 800, and require special handling to avoid risk to healthcare workers
What is an example of a reputable, up-to-date resource for prescribing/dispensing to pregnant women?
Briggs’ Drugs in Pregnancy and Lactation
What is preeclampsia?
Preeclampsia is a complication of pregnancy that presents with elevated blood pressure and evidence of organ damage, most often to the kidneys or liver
When does preeclampsia present?
It usually presents after the first trimester of pregnancy and can occur in women with previously normal blood pressure
What happens when preeclampsia is not treated?
If not treated, preeclampsia can progress to eclampsia, which can lead to seizures and death
What is the only cure for preeclampsia?
The only cure for preeclampsia is delivery of the baby
What does the ACOG and ADA guideline recommend to prevent preeclampsia?
Recommends adding daily low-dose aspirin at the end of the first trimester for pregnant women at risk for preeclampsia (e.g. type 1 or 2 diabetes, renal disease, history of preeclampsia, chronic hypertension)
What is the preferred management of morning sickness, nausea, vomiting in pregnancy?
- Lifestyle first: eat smaller, more frequent meals, drink plenty of water, avoid spicy or odorous foods, take more frequent naps, and reduce stress, including working long hours
- If lifestyle measures fail, ACOG recommends pyridoxine (vitamin B6) +/- doxylamine first line
- Rx: doxylamine/pyridoxine (Bonjesta, Diclegis)
What natural product can be effective for treating morning sickness?
Ginger is rated “possibly effective” for treating morning sickness
What is hyperemesis gravidarum?
Hyperemesis gravidarum is severe N/V, causing weight loss, dehydration and electrolyte imbalance. It will be treated under the care of an obstetrician and may require hospitalization
What is the preferred management of GERD/heartburn in pregnancy?
- Lifestyle first: eat smaller, more frequent meals, avoid foods that worsen GERD. If symptoms occur while sleeping, recommend elevating the head of the bed and not eating 3 hours prior to sleep
- If lifestyle measures fail, recommend antacids. Calcium antacids, such as calcium carbonate (Tums), are a good choice since calcium intake is often deficient
What can be done if heartburn symptoms in pregnancy are not relieved by Tums?
H2 receptor antagonists or PPIs can be considered for add-on therapy
What is the preferred management for flatulence in pregnancy?
Simethicone (Gas-X, Mylicon)
What is the preferred management of constipation in pregnancy?
- Lifestyle first: increased fluid intake, increased dietary fiber intake and increased physical activity
- If lifestyle measures fail, fiber (psyllium, calcium polycarbophil, methylcellulose), with adequate amounts of fluids, is preferred
- Docusate and polyethylene glycol are used to prevent and treat constipation
*Constipation is such a prevalent issue in pregnancy that many prenatal vitamins contain docusate
What is the preferred management of cough, cold, allergies in pregnancy?
- First line: cromolyn
- Second line: first-generation antihistamines; Chlorpheniramine (drug of choice) and diphenhydramine are commonly used
- The non-sedating second generation agents loratadine and cetirizine are often recommended by obstetricians during the second and third trimesters
- If nasal steroids are needed for chornic allergy symptoms, all intranasal steroids are considered to be safe with Budesonide (Rhinocort Allergy) and beclomethasone (Beconase AQ) are preferred
What medications should not be used for cough, cold, allergies in pregnancy?
- Oral decongestants should not be recommended during the first trimester
- Dextromethorphan and guaifenesin have limited safety data in pregnancy/lactation, but are sometimes used. Avoid liquid formulations that contain alcohol
What is the preferred management of pain in pregnancy?
- Non-drug options such as hot/cold packs, light massage or physical therapy can help limit or avoid the use of analgesics
- ACOG recommends acetaminophen first-line for mild pain during pregnancy because it has a better safety profile than NSAIDs and opioids
What are some medications that should be avoided for treating pain in pregnancy?
- Avoid NSAIDs, including aspirin, especially at 20 weeks gestation or later because NSAID use can cause premature closure of the fetal ductus arteriosus and kidney problems in the fetus (leading to low amniotic fluid
- Opioid metabolism can affect safety risk
What is the preferred management of asthma in pregnancy?
- Maintenance therapy: budesonie is preferred but all inhaled corticosteroids are considered safe for use in pregnancy
- Rescue therapy (short-acting beta agonist): inhaled albuterol
*Budesonide is also the preferred steroid for infants; the Respules are used in a nebulizer
What is the preferred management of iron deficiency anemia in pregnancy?
Supplemental iron, prenatal vitamins with iron
*Iron worsens constipation
What is the preferred management of hypertension in pregnancy?
Labetalol, methyldopa, nifedipine
What medications are contraindicated for the treatment of hypertension in pregnancy?
ACE inhibitors, ARBs, aliskiren and Entresto are contraindicated in pregnancy
What is the preferred management of diabetes in pregnancy?
- Insulin is preferred if not controlled with lifestyle
- Metformin and glyburide are commonly used
- Low dose aspirin is recommended for preeclampsia prevention in both type 1 and type 2 diabetes
*If diabetes develops during pregnancy, it is called gestational diabetes
What antibiotics are considered safe to use in pregnancy?
Penicillins (including amoxicillin and ampicillin), cephalosporins, erythromycin and azithromycin
What is the preferred management of vaginal fungal infections in pregnancy?
Topical antifungals (creams, suppositories) x 7 days
What is the preferred management for urinary tract infections in pregnancy?
- Cephalexin 500 mg PO Q6h x 7 days
- Ampicillin 500 mg PO 6h x 7 days
- Nitrofurantoin and SMX/TMP should be considered last line during 1st trimester and should not be used in the last 2 weeks of pregnancy
- Must treat bacteriuria, even if asymptomatic with negative urinalysis. Untreated bacteriuria can lead to premature birth, pyelonephritis and neonatal meningitis
What are complications of toxoplasmosis during pregnancy?
It can cause miscarriage, stillbirth or damage to the baby’s brain and eyes
How can toxoplasmosis be tested?
Women can be tested prior to pregnancy with an IgG test
What should pregnant women avoid to prevent toxoplasmosis?
Avoid dirty food and water, unpasteurized dairy products and cat feces which can contain the parasite
What antibiotics should be avoided in pregnancy?
Do not use: quinolones (due to cartilage damage) and tetracyclines (due to teeth discoloration)
What should be avoided to treat vaginal fungal infections in pregnancy?
Avoid fluconazole
What is the preferred management of VTE in pregnancy?
- Treatment: low molecular weight heparin (LMWH) is preferred over unfractionated heparin (UFH)
- Prophylaxis: pneumatic compression devices +/- LMWH (preferred over UFH)
What is the preferred management for pregnant women who have mechanical valves?
Women who require chronic warfarin therapy for mechanical heart vales or inherited thrombophilias are generally converted to LMWH during pregnancy. They may be switched back to warfarin after the 13th week of pregnancy, then back to LMWH close to delivery
What is not recommended in treatment of conditions requiring anticoagulation in pregnancy?
- Warfarin is teratogenic
- The oral factor Xa inhibitors and direct thrombin inhibitors have not been adequately studied in pregnancy and are not recommended
- Monitor peak anti-Xa levels, drawn 4 hours post-dose (LMWH), or aPTT (heparin)
What is the preferred management of hypothyroidism?
Levothyroxine (will require a 30-50% dose increase during pregnancy)
What are severe consequences of untreated hypothyroidism in pregnancy?
Includes miscarriage or stillbirth, preeclampsia, low birth weight, cognitive impairment and growth retardation
What is the preferred management of hyperthyroidism?
- Mild cases will not require treatment
- Preferable to normalize the mother’s thyroid function prior to pregnancy. Contraception should be used until the condition is controlled
- If drugs are necessary, PTU is preferred if trying to conceive or in the 1st trimester. After that, the decision is individualized, as both PTU and methimazole carry potential fetal risks. Historically, the patient would be switched to methimazole for the remainder of the pregnancy
What complications can PTU and methimazole cause?
Both PTU and methimazole have a high risk for liver damage, readily cross the placenta and can cause congenital defects
What can uncontrolled maternal hyperthyroidism cause?
Premature delivery and low birth weight
What does the AAP recommend with regards to breastfeeding?
The AAP recommends that babies be exclusively breastfed for the first six months of life, as long as it is mutually desired by the mother and baby and if safety risks are not present
What supplementation is needed for babies receiving breast milk?
Babies receiving breast milk partially or exclusively should receive 10 mcg (400 IU) of vitamin D daily until thy are consuming at least one liter of vitamin D-fortified formula/day. Human milk contains very little iron, so breastfed babies require 1 mg/kg daily iron during months 4-6
What supplementation is needed for breastfeeding mothers?
Mothers who are breastfeeding should increase their diet by 450-500 kcal/day and continue prenatal vitamins and omega-3 supplements
What kind of drugs have higher excretion into breast milk?
Excretion into breast milk is higher with drugs that are non-ionized, have a small molecular weight, a low volume of distribution and high lipid solubility
What resources can be used to check for drug safety during breastfeeding?
LactMed or Briggs’ Drug in Pregnancy and Lactation can be used to check for drug safety during breastfeeding
What can be used to treat postpartum pain?
Postpartum pain can often be adequately treated with acetaminophen or ibuprofen
What medications should not be used to treat postpartum pain?
Codeine and tramadol should not be used by breastfeeding mothers due to risk of excessive sleepiness, breathing difficulty and/or death in the infant
Is breastfeeding recommended in women with HIV?
Breastfeeding is not recommended for women with documented HIV infection in the United States, including those women receiving antiretroviral therapy
What drugs should be avoided completely during lactataion?
Chemotherapy, illicit drugs and radioactive compounds used fro treatment and diagnostic studies
What medications can patients be able to pump and dispose of the breastmilk when drug concentrations are at the highest?
Amphetamines, Amiodarone, Ergotamines, Lithium, Metronidazole, Phenobarbital and Statins
