|Risk in first trimester||Risk in second/third trimester||Risk at delivery||Recommendation||Breast feeding|
|Acid inhibitory drugs|
|H2 antagonists||No risk shown||Possible increased risk for asthma||No||Possible increased risk for asthma1||Possible compatible – low concentrations present in milk|
|Proton pump inhibitors||No risk shown||Not shown||No||PPI preferred||Compatible - low concentration in milk|
|Metoclopramide||No increased risk shown2||Monitor extrapyramidal syndrome in neonates in third trimester||Unknown3||Probably safe – first choice is meclozine second choice is metoclopramide5||Possible compatible4 – passes blood-brain-barrier, short term use possible|
|Domperidon||Limited human data||Limited human data||No||Probably safe – meclozine preferred during pregnancy||Low dose present – does not cross Blood-Brain-Barrier, monitor QT-interval|
|PEG +/− electrolytes|
|No data – systemic exposure neglible6||No data – systemic exposure negligible||No||No absorption is taking place – probably safe||Compatible – no oral absorption|
|Lubiprostone||Adverse effects in animals (fetal loss) – limited human data7||Adverse effects in animals (fetal loss) – limited human data||Unknown||Limited human data – avoid during pregnancy, Macrogol preferred||Avoid – no data|
|Senna||Limited human data shown no adverse effects8||Limited human data shown no adverse effects8||No||Short term use only||Possible compatible – low concentration in milk9|
|Bisacodyl||Animal studies show no adverse effects – limited human data10||Animal studies show no adverse effects – limited human data||No||Short term use only11||Compatible – no GI absorption|
|Associated with fetal nephro- and ototoxicity||Associated with eighth cranial nerve damage in fetus but not in CF literature||No||Reserve for life threatening infections – inhaled causes minimal risk due to limited systemic absorption||Probably compatible12 – monitor infant on GI flora effects i.e. diarrhea, candidiasis, beware of hypersensitivity|
|Ceftazidim (and other cephalosporins)||No risk shown||No risk shown||No||Probably safe – only on strict indication||Compatible - excreted in low concentrations13|
|Ciprofloxacin (and other fluorquinolones)||Unknown||Cartilage damage and arthropathy shown in animals14||No||Avoid during pregnancy, if needed ciprofloxacin drug of choice||Avoid - high concentration|
Ciprofloxacin - probably compatible12
|Clindamycin||No risk shown||No risk shown||No||Probably safe – use in absence of safer alternative||Possible Compatible – cases of bloody stool, monitor infant GI flora12,15|
|Erythromycin||No risk shown16||No risk shown||No||Use as first choice||Possible Compatible12|
|Azithromycin||Probably no risk||No risk shown||No||Erythromycin first choice||Probably compatible12|
|Roxithromycin||No risk shown16||Probably no risk||No||Erythromycin first choice||Possible compatible|
|Clarithromycin||No risk shown||No risk shown||No||Erythromycin first choice||Possible compatible – low concentration in milk, monitor infant|
|Amoxicillin (and other penicillins + clavulanate or tazobactam)||No risk shown||No risk shown||No||Probably safe||Compatible – trace in milk, beware hypersensitivity|
|Colistin (i.v., inhal.)||Limited human data||Limited human data||No||IV avoid if possible - Inhalation probably safe||Inhaled -possible compatible|
IV – caution (poorly absorbed from gut)
|Rifampicin (and other rifamycins)||Animal studies show adverse effect, no adequate human data17||Associated with risk of bleeding by mother and neonate in last trimester||No||Avoid during pregnancy, if necessary, treatment with phytomenadione of mother and neonate||Excretion in milk – discontinue nursing or drug based on importance of therapy|
|Trimethoprim is associated with neural defects – reduced by folic acid||Sulphonamide use in the last trimester is associated with icterus of the neonate||Sulphonamide use at delivery associated with fetal hemolytic anemia||Avoid during first and third trimester and at delivery||Compatible in healthy term babies – avoid if G6PD deficient or jaundiced|
|Trimethoprim||Trimethoprim is associated with neural defects – reduced by folic acid||Probably no risk if have normal folate status||No||Avoid during first trimester if needed, ensure adequate folate supplementation||Probably compatible12 – low concentration in milk|
|Doxycycline (and other tetracylines)||Risk of neural defects, reduced by folic acid||Tetracyclines associated with tooth discolorations and delayed osteogenesis||Associated with tooth and bone discoloration||Avoid during 2nd/3rd trimester and at delivery should not be first choice (amoxicillin, cephalexin or erythromycin) – doxycycline possible safe||Possible compatible12 – prolonged use tooth discoloration|
|Imipenem||Limited human data||No fetal damage in animals – limited humans studies18||No||Preferable drugs are penicillin, cephalosporin or erythromycin19||Possible compatible – present in milk, unlikely to be absorbed20|
|Meropenem||Fetal damage in animals – limited human studies21||No fetal damage found in animals – limited human studies21||Unknown||Preferable drugs are penicillin, cephalosporin or erythromycin22||Possible compatible – present in milk, unlikely to be absorbed23,24|
|Chloramphenicol||No fetal damage found in animals – limited human studies21||Use in last trimester associated with neonatal cyanosis and hypothermia (grey-baby syndrome)||Associated with grey-baby syndrome||Avoid during last trimester and at delivery||Avoid – vomiting, excessive intestinal gas and falling asleep25|
|Metronidazole||No increased risk26,27||No increased risk26,27||No||No proof for adverse effects on fetus||Probably compatible12 – discontinue for 12 h after intake|
|Phosphomycin||Animal data show adverse effects at maternal dose - Limited human data show no risk28,29||Animal data show adverse effects at maternal dose - Limited human data show no risk28,29||No||Drug of choice is nitrofurantoïne (not during delivery)|
Second choice amox/clav30
|Possible compatible – low levels in breastmilk31|
|Vancomycin||Unknown – no evidence of fetal damage||Unknown – no evidence of fetal damage||No||Avoid during pregnancy||Compatible – present in milk, but absorption unlikely|
|Teicoplanin||Animal studies show reproductive toxicity – limited human data32||Animal studies show reproductive toxicity – limited human data||Unknown||Avoid – no data||Possible compatible – limited data, poor oral availability due to high protein binding – monitor infant for GI problems33|
|Aztreonam (i.v./inhal.)||IV animal studies show no adverse reproductive effect – limited human studies34||IV administration crosses placenta and enter fetal circulation – limited human studies35||Unknown||Only give when potential benefit outweighs any potential risk – inhaled causes negligible systemic effect||Possible compatible36 – inhaled poor systemic absorption|
|Cinnarizine (and other antihistamines)||No increased risk shown – meclozine drug of choice||No increased risk shown – meclozine drug of choice||No||Probably safe to use||Avoid – limited data,|
meclozine drug of choice
|Fluconazole||Animal studies show major congenital anomalies – limited human data shows the same37||Increase of spontaneous abortion in human37||Yes||Dose>300mg contraindicated – lower doses avoid during first trimester||Possible compatible – present in milk (less than neonatal dosage)38|
|Itraconazole, voriconazole||Animal studies show teratogenicity – limited human data show increased spontaneous abortion37||No data available||Unknown||Avoid||Avoid – limited data38|
|Posaconazole||Animal studies show toxicity – no human data37||Animal studies show toxicity – limited human data||Unknown||Avoid||Avoid – no data|
|Amphotericin||Case reports show no increased risk39||Case reports show no increased risk39||No||Drug of choice during pregnancy||Possible compatible – high protein bound, poor oral absorption|
|Nystatin||Probably safe||Probably safe||No||Probably safe||Compatible – no oral absorption|
|Aciclovir||No risk shown||Use in second half of pregnancy to avoid transfer of virus to fetus||No||Drug of choice||Compatible40|
|Valaciclovir||No risk shown - limited human data||No risk shown – limited human data||No||Larger bioavailability – aciclovir preferred||Compatible|
|Ganciclovir||Animal studies reveal teratogenicity||No human data||Unknown||Contraindicated||Avoid – no data|
|Blood glucose lowering drugs|
|Insulins/insulin analogues||No risk||No risk||No risk||Human insulins preferred||Compatible12|
|Glibenclamide||Animal studies reveal teratogenicity – limited human data||Increased risk for respiratory distress, NICU, neonatal hypoglycemia, large for gestational age41||Increased risk for neonatal hypoglycemia||Human insulins preferred||Possible compatible – monitor infant blood glucose|
|Tolbutamide, netaglinide, repaglinide||Animal studies reveal teratogenicity – Limited human data||No adequate human studies – expected to cross placenta||Increased risk for neonatal hypoglycemia||Human insulins preferred||Possible compatible – monitor infant blood glucose|
|Metformin||No increased risk42||Probably no risk but avoid – insulin preferred||Neonatal hypoglycemia||Human insulins preferred||Compatible12|
|Pioglitazone and other thiazolidinediones||Fetal toxicity in animals||Fetal toxicity in animals43||Neonatal hypoglycemia||Human insulins preferred||Avoid – no data|
|Risedronate etc.||Limited human data show no substantial fetal risk44|
Animal reproduction studies shown adverse effect on fetus
|Limited human data show no substantial fetal risk – marginal decrease gestational age, birth weight and transient neonatal electrolytes45||Unknown||Limited human data shows no serious fetal or neonatal damage45 – Use with caution||Avoid – no data40|
|Ursodeoxycholic acid||No data||Human data show no increased risk46||No||Avoid during first trimester||Compatible – low levels in breast milk|
|Gastrografin||No risk anticipated with oral use||No risk anticipated with oral use||No||Probably no risk||Possible compatible – poor oral absorption, unlikely to reach infant bloodstream|
|Systemic||Fetal damage in animals (mainly schisis), not in humans – Prednisolone, hydrocortisone drugs of choice||Fetal damage in animals (intrauterine growth restriction in prolonged treatment, not in humans)||No||Systemic corticosteroids used for supplementation therapy in adrenal insufficiency. Neonate should be monitored for growth retardation, adrenal insuf., hypoglycemia||Compatible – monitor infant adrenal function if maternal dose exceeds 40 mg prednisolone – delay feeding for 4–6 h after dose|
|Dermal||Not probable to cause fetal damage||Not probable to cause fetal damage||No||Class I and Class II dermatocorticoids are preferred. Intermittend use. Class III/IV max. 1 week in acute phase||Compatible|
|Nasal, tracheal steroid metered dose inhalers and drops||No increased risk shown47||No increased risk shown||No||Can be used in pregnancy||Compatible|
|Sympathicomimetics inhaled||LABA – limited data|
SABA – probably safe (data shows malformations – due to asthma?)
|LABA – limited data|
SABA – probably safe (data shows malformations – due to asthma?)
|No||SABA – salbutamol/albuterol|
LABA – Salmeterol/formeterol
|Compatible – limited systemic absorption|
|Anticholinergic inhaled||Animal studies show no teratogenicity – limited human data48||Animal studies show no teratogenicity – limited human data48||No||Ipratropium preferred||Probably compatible – limited systemic absorption|
|Aminophylline/theophylline||Probably safe||Probably safe||Neonatal irritability, cardiac arrhythmias and apneas reported||Control theophylline plasma level in third trimester||Caution — present in milk: irritability in infants reported. Give modified release preparations after feeding|
|Pancreatic enzymes||No animal/human data shown – probably no risk49||No animal/human data shown – probably no risk||No||Probably no risk since no maternal absorption||Compatible – no maternal absorption|
|Dornase alfa||No fetal harm in animal studies, no human data50||No fetal harm in animal studies, no human data50||Unlikely/No||Due to inhaling no fetal harm expected – probably safe51||Possible compatible – due to large protein molecule absorption is low52|
|Vitamin A||Use of recommended dose of 800 RE safe53||Use of recommended dose of 800 RE safe53||No||Use of bètacarotene preferable – conversion rate adjusted to the amount of retinol is needed||Compatible – at prophylactic doses|
|Vitamin B group||Probably safe||Probably safe except high doses of B6 (neonatal convulsions)||No||Probably safe – use of high dose B6 contraindicated||Compatible|
|Vitamin C,E,K||Probably safe||Probably safe||No||Probably safe – High doses of vitamin C may cause paradoxical neonatal deficiency||Compatible|
|Vitamin D||Probably safe in prophylactic dose||Safe in prophylactic doses||No||Safe in prophylactic doses||Compatible – at prophylactic doses, high doses may cause hypercalcemia in infant|
|Cyclosporine||Adverse effects in animals – Human data show no increased risk of malformation54||Adverse effects in animals – Human data show no increased risk of malformation54||Risk of premature delivery - low birth weight||Maybe not teratogen – risk of premature delivery, low birth weight, developmental delay, increased risk on development of auto-immune diseases||Possible compatible – low levels in infant55 – monitor infant for liver and blood values, avoid breastfeeding 4–6 h after dose|
|Tacrolimus||Fetal damage in animals – limited human data show no increased risk56||Fetal damage in animals – limited human data show no increased risk56||Risk of premature delivery - low birth weight||Monitor infant on effect on kidneys, hyperkalemia||Possible compatible – present in low concentrations57 monitor infant for liver and blood values, avoid breastfeeding 4–6 h after dose|
|Azathioprine||Small increase of fetal malformations in animals||Small risk of neonatal immune and bone marrow suppression, premature delivery and low birth weight – monitor, weigh benefit for mother against possible effect on fetus||Risk of premature delivery - low birth weight||Conflicting outcomes studies - monitor blood during third trimester for leukopenia and pancytopenia||Possible compatible – avoid breastfeeding 4–6 h after dose, monitor infant for liver and blood values|
|Mycophenolate||Animal studies show reproductive toxicity – teratogen in humans58||Animal studies show reproductive toxicity – teratogen in humans||Risk of spontaneous abortions||Avoid – contraindicated59||Avoid – no data60|
|Class II modulator|
|Lumacaftor||No adverse effects in animal studies61||No adverse effects in animal studies||Unknown||Avoid – limited human data||Avoid – no human data|
|Class III modulator|
|Ivacaftor||Limited human data – no adverse effects in animal studies||Limited human data – no adverse effects in animal studies||Unknown||Avoid – limited human data||Avoid – no human data|
|Class IV modulator|
|Ivacaftor||See Class III CFTR modulators||See Class III CFTR modulators||See Class III CFTR modulators||See Class III CFTR modulators||See Class III CFTR modulators|
|Mannitol (inhal.)||Animal studies show no malformations – limited human data63,64||Animal studies show no malformations – limited human data63,64||Unknown||Due to local absorption, limited systemic effect -|
Possible hyper reactive response unknown64
|Avoid - unknown|
|Ibuprofen||Human data show no significant increase in birth defect risk65||Avoid – contraindicated due to increased risk of renal failure and premature closing ductus arteriosus and cryptorchism66||Yes||Can be used during first trimester – avoid during second/third trimester||Compatible|
|Influenza||No known adverse effects found67||Limited data show no adverse effects67||No||Limited data suggest vaccination is safe in the first trimester||Compatible68 - antibodies present in milk, vaccinate child in routine schedules|
|Pneumococcal||Animal studies show no adverse effects – limited human data suggest also no adverse effects69||Animal studies show no adverse effects – limited human data suggest also no adverse effects69||No||Use with caution||Compatible68 – antibodies present in milk, vaccinate child in routine schedules|
Conflicts of interest
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