Drugs safety in pregnancy


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Drugs safety in pregnancy

  1. 1. Drugs safety in pregnancy
  2. 2. <ul><li>The topic of &quot;drug safety in pregnancy&quot; embraces the effect of drugs on the pregnancy , foetus or neonate , and the effects of the pregnancy on drug disposition. Almost all drugs cross the placenta to some extent and may pose risk to the developing foetus. A few exceptions exist (e.g. insulin, heparin) which are very large molecules that do not cross biological membranes readily </li></ul>Background
  3. 3. <ul><li>Drugs taken by a pregnant woman reach the fetus primarily by crossing the placenta, the same route taken by oxygen and nutrients, which are needed for the fetus's growth and development. Drugs that a pregnant woman takes during pregnancy can affect the fetus in several ways </li></ul>Drug Use During Pregnancy
  4. 4. <ul><li>*They can act directly on the fetus, causing damage, abnormal development (leading to birth defects), or death. </li></ul><ul><li>*They can alter the function of the placenta, usually by causing blood vessels to narrow (constrict) and thus reducing the supply of oxygen and nutrients to the fetus from the mother. Sometimes the result is a baby that is underweight and underdeveloped . </li></ul><ul><li>*They can cause the muscles of the uterus to contract forcefully, indirectly injuring the fetus by reducing its blood supply or triggering preterm labor and delivery </li></ul>
  5. 5. <ul><li>Some of the fetus's blood vessels are contained in tiny hairlike projections (villi) of the placenta that extend into the wall of the uterus. The mother's blood passes through the space surrounding the villi (intervillous space). Only a thin membrane (placental membrane) separates the mother's blood in the intervillous space from the fetus's blood in the villi. Drugs in the mother's blood can cross this membrane into blood vessels in the villi and pass through the umbilical cord to the fetus </li></ul>How Drugs Cross the Placenta
  6. 6. <ul><li>The Food and Drug Administration (FDA) created the following rating system in 1979 to categorize the potential risk to the fetus for a given drug .  </li></ul><ul><li>Category A:     Controlled human studies have demonstrated no fetal risk Category B:     Animal studies indicate no fetal risk, but no human studies                        OR adverse effects in animals , but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy and there is no evidence of risk in the last two trimester </li></ul>
  7. 7. <ul><li>Category C:     No adequate human or animal studies,                        OR adverse fetal effects in animal studies, but no available human data..The benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Category D:     Evidence of fetal risk, but benefits outweigh risks. Category X:     Evidence of fetal risk. Risks outweigh any benefits </li></ul>
  8. 8. <ul><li>Hyperacidity, reflux, ulcers </li></ul><ul><li>Alginates/antacids Category C </li></ul><ul><li>H2receptor antagonist </li></ul><ul><li>Cimetidine, famotidine, ranitidine , nizatidine Category B </li></ul><ul><li>Proton pump inhibitor </li></ul><ul><li>Lansoprazole, Rabeprazole, pantoprazole Category B Except omeprazole Category C </li></ul><ul><li>Antispasmodics </li></ul><ul><li>Atropine ,hyoscine-N-butylbromide(Buscopan) Category C </li></ul>Alimentary system
  9. 9. <ul><li>Laxatives </li></ul><ul><li>Lactulose Category B </li></ul><ul><li>Bisacodyl Category C </li></ul><ul><li>Antidiarrhoeals </li></ul><ul><li>Diphenoxylate,Loperamide Category C </li></ul><ul><li>5Aminosalicylic acid Derivative </li></ul><ul><li>Mesalazine ,Sulfasalazine Category B </li></ul>
  10. 10. <ul><li>Antihypertensives </li></ul><ul><li>Methyldopa Category B </li></ul><ul><li>Sodium nitroprusside, Clonidine, Diazoxide Category C </li></ul><ul><li>Hydralazine Category C Following intravenous administration, hydralazine has been associated with fetal distress and fetal arrhythmia in the last trimester of pregnancy. </li></ul><ul><li>Calcium channel blockers Category C </li></ul><ul><li>Angiotensin converting enzyme (ACE) inhibitors & Angiotensin II receptor antagonists (ARAs) Category D </li></ul>
  11. 11. <ul><li>These agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant . </li></ul><ul><li>1 -Non selective B1+B2 blockade : Propranolol, Timolol ( Category C 1st,D 2nd &3rd trimester ) Sotalol (Category B 1st,D 2nd &3rd trimester) </li></ul><ul><li>2 -selective B1 Blockade : atenolol Category D , Metoprolol, esmolol,Bisoprolol (Category C 1st,D 2nd &3rd trimester) </li></ul><ul><li>3- Non selective B+alpha1 blockade Carvedilol,labetalol ( Category C ) </li></ul>Beta-adrenergic blocking agents
  12. 12. <ul><li>Carbonic anhydrase inhibitor </li></ul><ul><li>Acetazolamide Category C </li></ul><ul><li>Thiazides, related diuretics : Category D </li></ul><ul><li>loop diuretics : Ethacrynic acid B , Bumetanide& Furosemide C </li></ul><ul><li>These drugs may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. </li></ul><ul><li>Potassium sparing diuretics </li></ul><ul><li>Amiloride, triamterene Category B These drugs may result in electrolyte disturbances in the fetus </li></ul>Diuretics
  13. 13. <ul><li>Lignocaine Category B </li></ul><ul><li>Adenosine, disopyramide, procainamide , Flecainide, Mexiletine Category C </li></ul><ul><li>Quinidin e:This drug is structurally similar to quinine, which in high doses, has been shown to cause fetal damage. It has been used to treat fetal cardiac arrhythmia </li></ul><ul><li>Bretylium tosylate Category C This drug carries the potential for fetal hypoxia associated with maternal hypotension. </li></ul><ul><li>Glyceryl trinitrate Category B </li></ul><ul><li>Isosorbide dinitrate, isosorbide mononitrate Category C </li></ul>Antiarrhythmics Antiangina agents
  14. 14. <ul><li>The physiological hyperlipidaemia of pregnancy does not require treatment. </li></ul><ul><li>Cholestyramine,colestipol,Gemfibrozil,Clofibrate Category C </li></ul><ul><li>Cardiac inotropic agents </li></ul><ul><li>Digoxin and other cardiac glycosides Category C </li></ul><ul><li>Adrenergic stimulant </li></ul><ul><li>terbutaline Category B </li></ul><ul><li>Adrenaline, ephedrine, salbutamol, Dobutamine, phenylephrine, , pseudoephedrine </li></ul><ul><li>Dopamine Category C </li></ul>Hypolipidaemic agents
  15. 15. <ul><li>Dipyridamole, sildenafil citrate Category B , </li></ul><ul><li>Betahistine, isosorbide dinitrate, oxpentifylline, phentolamine, Isoxsuprine Category C Maternal isoxsuprine administration for prevention of premature labour has been associated with tachycardia, hypoglycaemia, hypocalcaemia and hypotension in the neonate. </li></ul><ul><li>Antimigraine preparations </li></ul><ul><li>Naratriptan, sumatriptan, zolmitriptan Category c </li></ul>Vasodilators
  16. 16. <ul><li>All of these agents can produce placental haemorrhage and subsequent prematurity and fetal loss. </li></ul><ul><li>Antiplatelet agent , </li></ul><ul><li>Ticlopidine,Clopidogrel Category B </li></ul><ul><li>Abciximab Category C </li></ul><ul><li>Low molecular weight heparin </li></ul><ul><li>Dalteparin, danaparoid, enoxaparin, nadroparin, </li></ul><ul><li>Category B </li></ul><ul><li>Other Heparin Category C . </li></ul><ul><li>tranexamic acid Category C </li></ul><ul><li>Fibrinolytic agents </li></ul><ul><li>Alteplase, urokinase ,Reteplase Category C </li></ul><ul><li>Streptokinase Category C Only minimal amounts of streptokinase cross the placenta. Streptokinase-specific antibodies are found in fetal blood </li></ul>
  17. 17. <ul><li>Analgesics, antipyretics </li></ul><ul><li>NSAIDS </li></ul><ul><li>Paracetamol category B </li></ul><ul><li>piroxicam ibuprofen, indomethacin B in 1ST tri, D 3rd tri </li></ul><ul><li>Diclofenac,ketoprofen, ketorolac, mefenamic acid, naproxen , celecoxib ,Meloxicom, Aspirin Category C /D3RD tri </li></ul><ul><li>These agents inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. </li></ul><ul><li>Opioid analgesics </li></ul><ul><li>Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. </li></ul><ul><li>Fentanyl,morphine , pethidine,tramadol ,Codeine Category C </li></ul>Central nervous system
  18. 18. <ul><li>Hypnotics and sedatives </li></ul><ul><li>Barbiturates & Benzodiazepines : Category D </li></ul><ul><li>Antipsychotic agents </li></ul><ul><li>Phenothiazines ( Chlorpromazine, trifluoperazine Category C ) </li></ul><ul><li>Butyrophenones ( haloperidol Category C ) </li></ul><ul><li>When given these in high doses during late pregnancy have caused prolonged neurological disturbances in the newborn infant Antidepressants </li></ul><ul><li>Selective serotonin reuptake inhibitors (SSRIs ) </li></ul><ul><li>Fluoxetine Category C </li></ul><ul><li>Monoamine oxidase inhibitor </li></ul><ul><li>phenelizine Category C </li></ul><ul><li>CNS stimulants </li></ul><ul><li>Caffeine Category C </li></ul><ul><li> Antiparkinson agents </li></ul><ul><li>Amantadine, carbidopa, levodopa, selegiline Category C </li></ul>
  19. 19. <ul><li>The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. </li></ul><ul><li>It is recommended that: </li></ul><ul><li>* women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; </li></ul><ul><li>* AED s should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; </li></ul><ul><li>*folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; </li></ul><ul><li>(Carbamazepine,phenytoin,sodium valeproate Category D) </li></ul><ul><li>Gabapentin Category C </li></ul>Anticonvulsants / Antiepileptics
  20. 20. <ul><li>Dimenhydrinate, diphenhydramine, metoclopramide ,ondansetron Category B </li></ul><ul><li>Phenothiazines : Prochlorperazine, promethazine, Category C </li></ul><ul><li>When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. </li></ul><ul><li>Others </li></ul><ul><li>Domperidone Category C </li></ul>Antiemetics, antinauseants
  21. 21. <ul><li>Muscle relaxants </li></ul><ul><li>Baclofen, botulinum type A , Dantrolene, methocarbamol, orphenadrine </li></ul><ul><li>Physostigime , Quinine Category C </li></ul><ul><li>Agents used in gout and hyperuricaemia </li></ul><ul><li>probenecid Category B </li></ul><ul><li>Allopurinol Category C </li></ul><ul><li>Sulfinpyrazone CategoryC (D if near term) </li></ul><ul><li>Corticosteroids </li></ul><ul><li>Systemic Category C : </li></ul><ul><li>Topical Category C Except ophthalmic suspension of triamcinolone D </li></ul><ul><li>Inhalation/Intranasal Category C Except Budesonide Category B </li></ul><ul><li>The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. </li></ul>
  22. 22. <ul><li>Pituitary hormones </li></ul><ul><li>Corticotrophin Category C </li></ul><ul><li>Antidiuretics </li></ul><ul><li>Desmopressin, vasopressin Category B </li></ul><ul><li>Hypoglycaemic agents (oral) </li></ul><ul><li>It is important to achieve strict normoglycaemia during pregnancy. This may best be achieved by conversion to insulin therapy. </li></ul><ul><li>Alpha-glucosidase inhibitor e.g: Acarbose Category B </li></ul><ul><li>Biguanide e.g: Metformin Category B </li></ul><ul><li>The sulphonylure Chlorpropamide, glibenclamide, gliclazide, glimepiride, glipizide, tolazamide, tolbutamide Category C The sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. </li></ul><ul><li>Thyroid hormones </li></ul><ul><li>Liothyronine, thyroxine Category A </li></ul>
  23. 23. <ul><li>Agents affecting calcium and bone metabolism </li></ul><ul><li>Biphosphonate derivative : Alendronate Category C </li></ul><ul><li>Calcitonin , Calcitriol Category C </li></ul><ul><li>Other hormonal agents . </li></ul><ul><li>Octreotide Category B . </li></ul><ul><li>Pituitary inhibitors </li></ul><ul><li>Bromocriptine Category B </li></ul><ul><li>Cabergoline Category B </li></ul><ul><li>Bladder function disorders Alpha 1 blocker Alfuzosin B, Tamsulosin B </li></ul><ul><li>Doxazosin C Prazosin C, Terazosin C </li></ul>
  24. 24. Antimicrobials <ul><li>Probable safe </li></ul><ul><li>1-Cephalosporins(B) </li></ul><ul><li>2-Pencillins(B) </li></ul><ul><li>3-Erythromycin(B) </li></ul><ul><li>(other than estolate) </li></ul>
  25. 25. Prescribe with caution <ul><li>1-Aminoglysides © </li></ul><ul><li>2-Antitubercular drugs (c) </li></ul><ul><li>3-chloramphenicol </li></ul><ul><li>4-clindamycin (c) </li></ul><ul><li>5-dapsone(especially at term) </li></ul><ul><li>6-lincomycin </li></ul><ul><li>7-metronidazole(7) </li></ul><ul><li>8-Nitrofurantion(Contraindicated at term)(B) </li></ul><ul><li>9-Sulphobamides(Contraindicated at term) </li></ul><ul><li>10-Trimethoprim© </li></ul><ul><li>11-T-S(Contraindicated at term)(B) </li></ul><ul><li>12-Vancomycin© </li></ul>
  26. 26. <ul><li>Contraindication </li></ul><ul><li>Erythromycin estolate </li></ul><ul><li>Nalidixic acid & other quinolones© </li></ul><ul><li>Tetracycline(D) </li></ul><ul><li>Topical vaginal medication </li></ul><ul><li>Clindamycin, clotrimazole, , nystatin Category B </li></ul><ul><li>econazole, miconazole Category c </li></ul>
  27. 27. <ul><li>Antifungal Agents </li></ul><ul><li>Amphotericin, Terbinafine, Nystatin Category B </li></ul><ul><li>Fluconazole , griseofulvin, itraconazole, ketoconazole Category C </li></ul><ul><li>Antiviral agents </li></ul><ul><li>Aciclovir, Didanosine , ritonavir, valaciclovir Category B </li></ul><ul><li>Indinavir, foscarnet, lamivudine zidovudine Category C </li></ul><ul><li>Anthelmintics </li></ul><ul><li>Praziquantel Category B </li></ul><ul><li>Albendazole, mebendazole Category C </li></ul>
  28. 28. Respiratory system <ul><li>Antitussive </li></ul><ul><li>Opium alkaloids and derivatives: codeine, dextromethorphan, dihydrocodeine, Category C </li></ul><ul><li>Expectorants and mucolytics </li></ul><ul><li>Ammonium chloride, bromhexine, guaiphenesin, ipecacuanha, Category C </li></ul><ul><li>Decongestants </li></ul><ul><li>Phenylephrine, pseudoephedrine Category C </li></ul><ul><li>Inhalational agents </li></ul><ul><li>Bronchospasm relaxants </li></ul><ul><li>Terbutaline, Ipratropium bromide Sodium cromoglycate, Category B </li></ul><ul><li>Ephedrine, isoprenaline, salbutamol, , theophylline derivatives Category C </li></ul>
  29. 29. <ul><li>Preventive aerosols and inhalations </li></ul><ul><li>budesonide Category B </li></ul><ul><li>Beclomethasone, , fluticasone, salmeterol Category C The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. </li></ul><ul><li>Other respiratory agents </li></ul><ul><li>Acetylcysteine , montelukast, zafirlukast Category B </li></ul><ul><li>Allergy and immune system </li></ul><ul><li>Antihistamines </li></ul><ul><li>Cetirizine , fexofenadine Chlorpheniramine, triprolidine ,hydroxyzine , promethazine Category C </li></ul><ul><li>Loratadine ,Cyclizine,Meclizine clemastine ,cyproheptadine , diphenhydramine, Category B </li></ul>
  30. 30. <ul><li>Neuromuscular blocking agents </li></ul><ul><li>Atracurium, Suxamethonium Category C </li></ul><ul><li>Detoxifying agents, antidotes </li></ul><ul><li>Acetylcysteine (intravenous) Category B </li></ul><ul><li>digoxin immune fab, Desferrioxamine, flumazenil , Naloxone Category C </li></ul><ul><li>Drugs used in myasthenia gravis </li></ul><ul><li>neostigmine CategoryC </li></ul><ul><li>Pyridostigmine Category B </li></ul>
  31. 31. <ul><li>* Folic acid Category A </li></ul><ul><li>* Vitamin A Category (A/C dose exceeding RDA recommended dose) </li></ul><ul><li>* Vitamin C Category A/Cdose exceeding RDA recommended dose) </li></ul><ul><li>* Vitamin E Category A/C dose exceeding RDA recommended dose) </li></ul><ul><li>* Vitamin B Category A/Cdose exceeding RDA recommended dose) </li></ul><ul><li>* Vitamin D Category C </li></ul><ul><li>* Vitamin K Category C </li></ul>Vitamins