Safety of dermatologic medications in pregnancy and lactation

Butler, David F.; Heller, Misha M.; Murase, Jenny E.

doi:10.1016/j.jaad.2013.09.009

Cited by 80 publications

(113 citation statements)

References 81 publications

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“…Information on excretion of the medicine in human milk is also critical in clinical practice. For many conditions such as epilepsy, rheumatoid arthritis or dermatologic pathologies, some drug therapy is compatible with breastfeeding and therefore there would be no need to withdraw the neonate from the benefits of breastfeeding [8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

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AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

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Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

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“…13,14 O uso de isotretinoína durante o aleitamento está também contra-indicado pois as concentrações no leite são significativas. 15 Em virtude da sua imaturidade renal e hepática, os níveis séricos nos lactentes poderiam atingir níveis tóxicos, predispondo a complicações como hepatotoxicidade, aumento da pressão intracraniana, dores ósseas e articulares, e aumento do risco de infeção respiratória. 15 Importa ter em atenção que a acitretina é convertida no organismo em etretinato, com uma semivida de 168 dias, podendo levar até 3 anos para ser completamente eliminado do organismo.…”

Section: Retinóides Sistémicos (Categoria De Risco X Pela Fda)unclassified

“…15 Em virtude da sua imaturidade renal e hepática, os níveis séricos nos lactentes poderiam atingir níveis tóxicos, predispondo a complicações como hepatotoxicidade, aumento da pressão intracraniana, dores ósseas e articulares, e aumento do risco de infeção respiratória. 15 Importa ter em atenção que a acitretina é convertida no organismo em etretinato, com uma semivida de 168 dias, podendo levar até 3 anos para ser completamente eliminado do organismo. 16 Os riscos teratogénicos prolongados fazem com que a acitretina não seja indicada em mulheres em idade fértil.…”

Section: Retinóides Sistémicos (Categoria De Risco X Pela Fda)unclassified

“…20,21 Existe um risco teórico, mas ainda não confirmado, de que o efeito sedativo possa aumentar o risco de síndrome de morte súbita do lactente, sendo por isso preferível recorrer a anti-histamínicos não sedativos durante a amamentação. 15 A administração de loratadina foi associada a um aumento do risco de hipospádia, contudo esta associação não foi confirmada em estudos subsequentes. 22,23 Nenhum efeito teratogénico foi detetado em humanos com a cetirizina.…”

Section: Retinóides Sistémicos (Categoria De Risco X Pela Fda)unclassified

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Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

Cesar

Azevedo

Mota

2016

SPDV

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RESUMO -O crescente número de fármacos empregues na prática dermatológica e venereológica exige do dermatologista um conhecimento atualizado relativo à sua segurança. No caso particular de mulheres grávidas ou que amamentem, a decisão sobre se se deve ou não tratar com um determinado fármaco deve basear-se numa avaliação ponderada dos benefícios para a saúde materna e dos riscos potenciais para o bem-estar fetal ou do lactente. Quando estas doentes necessitam terapêuticas tópicas ou sistémicas, a maioria pode ser adequadamente tratada com opções consideradas seguras e eficazes. Na primeira parte deste artigo são abordados os dados mais recentes relativos à segurança de alguns dos medicamentos sisté-micos mais comummente usados em contexto dermatológico, na mulher em idade fértil. PALAVRAS-CHAVE -Agentes Dermatológicos/uso terapêutico; Aleitamento/efeito dos medicamentos; Complicações na Gravidez/quimioterapia; Doenças da Pele/quimioterapia; Doenças de Pele/tratamento; Gravidez. Pregnancy, Lactation and Drugs in DermatologySystemic Therapy ABSTRACT -The increasing number of drugs used in dermatological a venereological practice demands from the dermatologist INTRODUÇÃOAo tratar doentes grávidas ou durante o período de aleitamento é fundamental um conhecimento dos potenciais efeitos adversos dos medicamentos sobre o desenvolvimento do feto ou do lactente. O risco de teratogenicidade e a capacidade de cada fármaco ser excretado no leite materno permite, na maioria das ocasiões, optar por alternativas seguras no tratamento de doenças do foro dermatológico em mulheres durante o período gestacional e durante a amamentação.Este artigo de revisão tem por objetivo abordar os dados disponíveis referentes à segurança (ou falta dela) de alguns dos fármacos mais comummente prescritos em contexto dermatológico e venereológico nas mulheres em idade fér-til. A primeira parte deste artigo aborda os fármacos administrados por via sistémica e a segunda parte irá abordar os fármacos de aplicação local. Corticosteróides sistémicos (categoria de risco C pela Food Drug Administration -FDA)A dexametasona e a betametasona não sofrem metabolização placentária significativa, passando inalterados através da placenta.1 Já a prednisolona sofre conversão em metabolitos inativos pela placenta humana, o que limita a sua passagem para o embrião/feto, pelo que é a opção

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“…The bioavailability is increased when used with high fat foods. 1 Its use is forbidden in women who are pregnant or are planning to be, due to its serious teratogenic effects. Acitretin binds with albumin and is metabolized in the liver.…”

Section: Introductionmentioning

confidence: 99%

Severe Hepatotoxic Injury and Cirrhosis Due to Acitretin

Mokhtare¹

2017

JLRDT

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We report a case of 48year old man presented with icter, itching and nausea and vomiting. He had developed a severe hepatotoxic reaction, after treatment with acitretin (oral retinoid, which is the derivative of etretinate). Histological findings showed the development of liver fibrosis and cirrhosis. Elevated serum aminotransferase levels, which are usually reversible, have been reported during treatment with acitretin, however; the present study indicates a warning message that severe hepatotoxic injury may follow this treatment. Ab, HCV Ab, HIV Ab1, 2, Anti HSV Ab, Anti EBV Ab, Anti VZV Ab, Anti CMV Ab) with negative results and the other laboratory investigations such as; Antinuclear Ab, ASMA, Anti-LKM Ab, serum protein electerophoresis, Ferritin, Anti-mitochondrial Ab, P-ANCA, ASCA, IgG4, TSH, Anti-tissue transglutaminase IgG and IgA Ab) with normal range results. LDH and liver enzyme were decreased during hospital course without any significant change in ALP and Bilirubin level. KeywordsUpper endoscopy was done with normal results. Magnetic Resonance Cholangiopancreatography (MRCP) was done with the result of periportal and pericholecystic edema and decreased intrahepatic bile ducts diameter due to parenchymal hepatic edema. The other parts were normal according to the report (Figure 1). Figure 1Periportal and pericholecystic edema were found, the diameter of intrahepatic bile ducts was less than normal and pruned that could be due to parenchymal hepatic edema.Finally, liver biopsy was done .The sample was stained with Hematoxylin, and Eosin, Trichrome and Reticulin. Extensive lobular architecture disarray with marked necro-inflammatory changes of parenchyma characterized by obvious hydropic changes and single cell necrosis of hepatocytes as well as infiltration of mixed inflammatory cells was shown in Hematoxylin, and Eosin staining (Figure 2). Collapse of reticulin network associated with psuedolobule formation as well as portal fibrosis was shown in Reticulin and MassonTrichrome staining (Figure 3,4). Overall findings were in favor of an acute/sub acute liver injury according to Modified HAI score grade: 14/18, stage: 3/6. The patient with the diagnosis of acitretin induced cirrhosis was referred to liver transplantation clinic. After one week admission course the patient was discharged with relative symptome relief and was requested for monthly follow-up .Five months later in monthly follow-up visit ,these data was found; AST=31U/L(12- Liver fibroscan (Fibroscan model 502 touch, Echosence France, Paris) was done 5months later that revealed fibrosis score of F3 (10.1kPa) based on metavir histological index, and steatosis score of 332 (dB/m) which is equal to 80% steatosis, S3 stage. We followed the patient for 9months without any change in general clinical condition and liver function tests. DiscussionThe American Academy of Dermatology suggests a protocol for monitoring of these patients, as follows: CBC and renal function tests (baseline and then every 12weeks); lipid profile BS in diabetic p...

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Safety of dermatologic medications in pregnancy and lactation

Cited by 80 publications

References 81 publications

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

Severe Hepatotoxic Injury and Cirrhosis Due to Acitretin

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