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Drug use during Pregnancy and Lactation

Pregnancy and lactation_2007.ppt

1104421 - Clinical Pharmacy IA

Objectives
To introduce concepts related to administration of drugs to pregnant women

To understand how drugs are classified to guide use during pregnancy To be able to provide appropriate guidance on drug use during pregnancy

To introduce concepts related to administration of drugs to breastfeeding women

To understand drug use during breastfeeding To be able to provide appropriate guidance on drug use during breastfeeding
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Reading
Chapter - Pregnancy and Lactation Pharmacotherapy Handbook 6th Ed. Barbara G Wells (Editor), Joseph T DiPiro (Editor), Terry L Schwinghammer (Editor), Cindy W Hamilton (Editor) Chapter - Pregnancy and Lactation: Therapeutic considerations McCombs J and Cramer MK IN: Pharmacotherapy: a pathophysiological approach. 6th Edition. Ed. Joseph T. Dipiro et al. Elsevier Science Publishing Co. Inc., New York 1999.
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Normal pregnancy
40 weeks from date of conception
Generally divided into 3 trimesters

1:25 babies born in Australia has a birth defect General health advice
Smoking Folic acid supplementation
> Neural tube defects

Underlying risk, not all related to medication

Diet

0.4/5mg daily before conception and for 12 weeks after

1104421 - Clinical Pharmacy IA

Drug use during pregnancy


Most medicines cross the placenta
Even if cross placenta may not cause problems

During first 2 weeks (conception to first missed period) embryo is thought to be resistant to teratogenic effects Critical period of development is 17 days70 days post conception
Exposure during this period can cause major birth defects
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What is a teratogen?
A chemical which has the capability to produce congenital abnormalities Factors influencing teratogenicity of a drug include:
Genotype of mother and fetus Embryonic stage at exposure Dose Specificity of drug
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Medications known to be teratogens


Alcohol ACE inhibitors Antithyroid drugs Benzodiazepines Carbamazepine Cocaine Cyclophosphamide Danazol Diethylstilbestrol Isotretinoin Lithium Methotrexate Misoprostol Phenytoin Tetracyclines Thalidomide Valproic acid Warfarin

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Case 1
Mrs McDonald enters the pharmacy and says that she needs to take regular medication but would like to become pregnant. What effect will it have on the baby?
What do you tell her? Where will you find the information?

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Case 2
28yr old women asks the pharmacist for advice on whether she can still take her antiepileptic drug whilst she is pregnant.
What are her options? Where can you find the information you need? What should you tell her?

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FDA pregnancy risk classification


CATEGORY INTERPRETATION A Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
> Paracetamol

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FDA pregnancy risk classification


B
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR 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 in any trimester. Examples Penicillins, B-lactam antibiotics, macrolides (erythromycin), Metronidazole, nystatin

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FDA pregnancy risk classification


> C Animal studies have shown an adverse effect
and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

> Calcium channel blockers Potential to cause fetal hypoxia due low maternal BP > Statin hypolipidaemics Cholesterol is necessary for fetal development > Opiod analgesics May cause fetal respiratory depression or withdrawal symptoms in newborn > Aspirin Avoid in last trimester Inhibits prostaglandin synthesis
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FDA pregnancy risk classification

Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.
> Carbamazepine (Tegretol), phenytoin (Dilantin), sodium valproate (Epilim) > Doxycycline > most anticancer agents > ACE inhibitors (eg.enalapril) and AII antagonists (e.g.losartan)

> Paroxetine (Paxil)

Intereferes with renal development in second and third trimester, resulting in renal dysfunction

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FDA pregnancy risk classification


X Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.
> > > > > Isotretinoin (Accutane), tretinoin (Retin-A) Raloxifene (Evista) thalidominde Misoprostol (Cytotec) Warfarin (Coumadin)
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Drug use in pregnancy


Generally four options
1. 2. 3. 4. Stop taking the drug Continue to take the drug Change to another less toxic drug If available take something to reduce the likelihood of toxic effects

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Stop taking the drug


Where possible drug use should be avoided during pregnancy Stopping a drug may be a possible (or necessary) solution depending on indication for drug
Necessary for most toxic groups of drugs
> Category X
Not recommended for use during pregnancy or when there is a chance of pregnancy

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Continue taking the drug


May be best option
Consider drug category

Consider whether stabilized on treatment


> Well controlled disease is probably safer for mother and baby than stopping or changing treatment

> Not OK for category X

Consider whether other treatment alternatives exist

> Insulin instead of oral hypoglycemics > Non-drug therapies


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Change to another drug


May be possible to choose less toxic drug
> Eg. Heparin therapy in place of warfarin for woman with history of DVT

Treatment effectiveness (of less toxic drug) may need to be established


> May take significant period of time
Eg. Antiepileptic therapies

Need to balance benefits and risk

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Add a supplement
If continuing with necessary drug therapy then may need to add supplements to reduce chance of teratogenic effects
Folic acid supplementation Vit K (prevent haemorrhagic disease of the newborn) Both could be used in antiepileptic agentssome have been implicated in above condition)

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Conditions caused or exacerbated by Pregnancy


Nausea and vomiting: -Morning Sickness; affects about of pregnant women mainly in 1st trimester. Manage by dietary intervention ( dry crackers 1520 min before arising), small dry meals high in carbs, avoid spicy foods and those with noxius odors. Meds have been used including phenothiazines (Prochlorperazine) , meclizine, dimenhydrinate, doxylamine , pyroxidine and ondansetron.

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Conditions caused or exacerbated by Pregnancy


Hyperemesis gravidarum : is severe N/V that could lead to dehydration and malnutrition. Hospitalization is required with proper fluid hydration , antiemetics sedatives and may be parenteral nutrition.

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Conditions caused or exacerbated by Pregnancy


Heartburn: Many experience during latter half of pregnancy. Manage by dietary modification first: smaller more frequent meals, avoiding liquids other than water 3 hours before bedtime, raising the head of the bed with blocks also helps. Antacids like magnesium and aluminiumcontaining products help alleviate the symptoms, calcium carbonate could be used for short periods to prevent rebound effect.
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Conditions caused or exacerbated by Pregnancy


Constipation: common problem resulting from decreased peristalsis. Manage by adding bulk laxatives like fibercon and citrucel to diet, increasing fluid intake ( at least 8 glasses/day) Avoid mineral oil (parafin oil) in any dosage as it could impair vitamin K absorption in mother leading to low vit, K available for fetus and possible causing hypoprothrombinemia.
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Conditions caused or exacerbated by Pregnancy


Hemorrhoids: caused by constipation and increased venous pressure below the uterus. Correction of constipation, use of stool softeners and sitz baths are helpful. Avoid topical preps containing anesthetics or steroids as absorption could happen. Procto-glyvenol crm. or supp. has been used safely.

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Conditions caused or exacerbated by Pregnancy


Coagulation Disorders: Thromboembolic phenomena are common in pregnancy. Warfarin should be avoided. Sub Q heparin and low -molecular-weight heparins (LMWH) are drugs of choice as effect can be reversed by protamine sulfate in case surgery is needed. Heparin is assoc. with osteoporosis which may or may not be reversible and it also could cause thrombocytopenia.

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Treatment of common conditions


Allergies
Oral first-generation antihistamines > Chlorpheniramine (in combination products), dexchlorpheniramine > Second-generation (non-sedating agents) are (also recommended, eg. Telfast); loratadine (Claratin) Avoid in first trimester Loratadine is the preferred non sedating antihistamine after the first trimester > Nasal sod. cromolyn is a topical product with safe profile > Nasal corticosteroids may be used for allergic rhinitis (Beconase/Allergy, Rhinocort)
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Treatment of common conditions


Asthma
Inhaled prn short-acting -agonist (eg. Ventolin) Inhaled corticosteroids: budesonide (Pulmicort), beclomethasone (Qvar), fluticasone (Flixotide) safe to use although have differing classification categories Inhaled corticosteroid/long-acting -agonist (Seretide) Oral B-agonists and theophylline appear to have no negative effect as well. Benefit>>risk Asthma control is extremely important

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Treatment of common conditions


Diabetes Incidence of malformations increases in poorly controlled diabetes Insulin is treatment of choice > For both type 1 and type 2 patients Goals for self-monitoring of blood glucose is important Oral hypoglycemics should be avoided as they could cause fetal hypoglycemia, they may be tertogenic as well and so should be stopped before conception if possible. Gestational diabetes is usually managed first by diet and then insulin.
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Treatment of common conditions


Epilepsy
risk of teratogenicity is probably greatest with sodium valproate, then carbamazepine and then phenytoin & primidone. > Risk increases with polytherapy > Phenobarbital has been drug of choice in pregnancy due to vast experience with the drug risk of an abnormality is about 2-3 times that of the general population medication change not usually recommended > All women taking antiepileptics should take folic acid 5mg before conception and 12 weeks after 29 1104421 - Clinical Pharmacy IA

Treatment of common conditions


Hypertension
Generally recommended agents are older agents
> Methyldopa (Aldomet) > Clonidine (Catapres) > Labetolol (Trandate) > Prazosin (Minipress) > Hydralazine (Apresoline)

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Treatment of common conditions


Psychotropic agents
Treatment should involve psychotherapy Lowest possible dose
> Olanzapine , chlorpromazine (cat C) > Benzodiazepines (Cat C) > Antidepressants

Benefits may outweigh risk

citalopram, fluvoxamine, sertraline- Cat C mirtazepine. tricyclics- Cat C paroxetine- Cat D

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Treatment of common conditions


Thyroid disorders
Hypothyroidism
> Thyroid replacement therapy
Should continue or be implemented Thyroxine Dose may increase by 25-50%(pregnancy itself affects dosing)

Hyperthyroidism

> Consider surgery prior to pregnancy > either methimazole or propylthiouracil (PTU)can be continued through pregnancy using the smallest possible dose
High doses may cause congenital goitre
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