Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential ris...
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| Veröffentlicht in: | Clinical pharmacology and therapeutics 2017-06, Vol.101 (6), p.736-744 |
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| creator | Wang, J Johnson, T Sahin, L Tassinari, MS Anderson, PO Baker, TE Bucci‐Rechtweg, C Burckart, GJ Chambers, CD Hale, TW Johnson‐Lyles, D Nelson, RM Nguyen, C Pica‐Branco, D Ren, Z Sachs, H Sauberan, J Zajicek, A Ito, S Yao, LP |
| description | This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants. |
| doi_str_mv | 10.1002/cpt.676 |
| format | Article |
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The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.</description><identifier>ISSN: 0009-9236</identifier><identifier>EISSN: 1532-6535</identifier><identifier>DOI: 10.1002/cpt.676</identifier><identifier>PMID: 28510297</identifier><language>eng</language><publisher>United States</publisher><subject>Biological Products - adverse effects ; Breast Feeding - adverse effects ; Congresses as Topic ; Consensus Development Conferences as Topic ; Drug-Related Side Effects and Adverse Reactions - etiology ; Female ; Humans ; Infant ; Infant, Newborn ; Lactation ; Maternal Exposure - adverse effects ; Models, Biological ; Pregnancy ; Risk Assessment ; Risk Factors</subject><ispartof>Clinical pharmacology and therapeutics, 2017-06, Vol.101 (6), p.736-744</ispartof><rights>2017, The American Society for Clinical Pharmacology and Therapeutics</rights><rights>2017, The American Society for Clinical Pharmacology and Therapeutics.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4056-45f577734539f4430300eb0e4687492a123c8d2b3b98c7bf93cda4a7d04508623</citedby><cites>FETCH-LOGICAL-c4056-45f577734539f4430300eb0e4687492a123c8d2b3b98c7bf93cda4a7d04508623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcpt.676$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcpt.676$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28510297$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wang, J</creatorcontrib><creatorcontrib>Johnson, T</creatorcontrib><creatorcontrib>Sahin, L</creatorcontrib><creatorcontrib>Tassinari, MS</creatorcontrib><creatorcontrib>Anderson, PO</creatorcontrib><creatorcontrib>Baker, TE</creatorcontrib><creatorcontrib>Bucci‐Rechtweg, C</creatorcontrib><creatorcontrib>Burckart, GJ</creatorcontrib><creatorcontrib>Chambers, CD</creatorcontrib><creatorcontrib>Hale, TW</creatorcontrib><creatorcontrib>Johnson‐Lyles, D</creatorcontrib><creatorcontrib>Nelson, RM</creatorcontrib><creatorcontrib>Nguyen, C</creatorcontrib><creatorcontrib>Pica‐Branco, D</creatorcontrib><creatorcontrib>Ren, Z</creatorcontrib><creatorcontrib>Sachs, H</creatorcontrib><creatorcontrib>Sauberan, J</creatorcontrib><creatorcontrib>Zajicek, A</creatorcontrib><creatorcontrib>Ito, S</creatorcontrib><creatorcontrib>Yao, LP</creatorcontrib><title>Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary</title><title>Clinical pharmacology and therapeutics</title><addtitle>Clin Pharmacol Ther</addtitle><description>This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.</description><subject>Biological Products - adverse effects</subject><subject>Breast Feeding - adverse effects</subject><subject>Congresses as Topic</subject><subject>Consensus Development Conferences as Topic</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Female</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Lactation</subject><subject>Maternal Exposure - adverse effects</subject><subject>Models, Biological</subject><subject>Pregnancy</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><issn>0009-9236</issn><issn>1532-6535</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kE1Lw0AQhhdRbK3iP5C9eZDUzX4kWQ-CtvUDChba4nHZbDZpNM2G3aTSf29itejB0zDMO88MDwDnPhr6COFrVdXDIAwOQN9nBHsBI-wQ9BFC3OOYBD1w4txb21IeRceghyPmI8zDPpCTjSwaWeemhCaF9UrDuUx1ve26sW0yB2WZwPvcFCbLlSzgzJqkUbWDS6cTOG5sXmZwKlX9BbmBr8a-u5Wp4LxZr6XdnoKjVBZOn33XAVg-TBajJ2_68vg8upt6iiIWeJSlLAxDQhnhKaUEEYR0jDQNopByLH1MVJTgmMQ8UmGccqISSWWYIMpQFGAyALc7btXEa50oXdZWFqKyefeFMDIXfydlvhKZ2QjGeCsjaAGXO4Cyxjmr0_2uj0RnWbSWRWu5TV78PrXP_WhtA1e7wEde6O1_HDGaLTrcJ7ZZhrE</recordid><startdate>201706</startdate><enddate>201706</enddate><creator>Wang, J</creator><creator>Johnson, T</creator><creator>Sahin, L</creator><creator>Tassinari, MS</creator><creator>Anderson, PO</creator><creator>Baker, TE</creator><creator>Bucci‐Rechtweg, C</creator><creator>Burckart, GJ</creator><creator>Chambers, CD</creator><creator>Hale, TW</creator><creator>Johnson‐Lyles, D</creator><creator>Nelson, RM</creator><creator>Nguyen, C</creator><creator>Pica‐Branco, D</creator><creator>Ren, Z</creator><creator>Sachs, H</creator><creator>Sauberan, J</creator><creator>Zajicek, A</creator><creator>Ito, S</creator><creator>Yao, LP</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>201706</creationdate><title>Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary</title><author>Wang, J ; Johnson, T ; Sahin, L ; Tassinari, MS ; Anderson, PO ; Baker, TE ; Bucci‐Rechtweg, C ; Burckart, GJ ; Chambers, CD ; Hale, TW ; Johnson‐Lyles, D ; Nelson, RM ; Nguyen, C ; Pica‐Branco, D ; Ren, Z ; Sachs, H ; Sauberan, J ; Zajicek, A ; Ito, S ; Yao, LP</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4056-45f577734539f4430300eb0e4687492a123c8d2b3b98c7bf93cda4a7d04508623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Biological Products - adverse effects</topic><topic>Breast Feeding - adverse effects</topic><topic>Congresses as Topic</topic><topic>Consensus Development Conferences as Topic</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Female</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Lactation</topic><topic>Maternal Exposure - adverse effects</topic><topic>Models, Biological</topic><topic>Pregnancy</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wang, J</creatorcontrib><creatorcontrib>Johnson, T</creatorcontrib><creatorcontrib>Sahin, L</creatorcontrib><creatorcontrib>Tassinari, MS</creatorcontrib><creatorcontrib>Anderson, PO</creatorcontrib><creatorcontrib>Baker, TE</creatorcontrib><creatorcontrib>Bucci‐Rechtweg, C</creatorcontrib><creatorcontrib>Burckart, GJ</creatorcontrib><creatorcontrib>Chambers, CD</creatorcontrib><creatorcontrib>Hale, TW</creatorcontrib><creatorcontrib>Johnson‐Lyles, D</creatorcontrib><creatorcontrib>Nelson, RM</creatorcontrib><creatorcontrib>Nguyen, C</creatorcontrib><creatorcontrib>Pica‐Branco, D</creatorcontrib><creatorcontrib>Ren, Z</creatorcontrib><creatorcontrib>Sachs, H</creatorcontrib><creatorcontrib>Sauberan, J</creatorcontrib><creatorcontrib>Zajicek, A</creatorcontrib><creatorcontrib>Ito, S</creatorcontrib><creatorcontrib>Yao, LP</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical pharmacology and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wang, J</au><au>Johnson, T</au><au>Sahin, L</au><au>Tassinari, MS</au><au>Anderson, PO</au><au>Baker, TE</au><au>Bucci‐Rechtweg, C</au><au>Burckart, GJ</au><au>Chambers, CD</au><au>Hale, TW</au><au>Johnson‐Lyles, D</au><au>Nelson, RM</au><au>Nguyen, C</au><au>Pica‐Branco, D</au><au>Ren, Z</au><au>Sachs, H</au><au>Sauberan, J</au><au>Zajicek, A</au><au>Ito, S</au><au>Yao, LP</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary</atitle><jtitle>Clinical pharmacology and therapeutics</jtitle><addtitle>Clin Pharmacol Ther</addtitle><date>2017-06</date><risdate>2017</risdate><volume>101</volume><issue>6</issue><spage>736</spage><epage>744</epage><pages>736-744</pages><issn>0009-9236</issn><eissn>1532-6535</eissn><abstract>This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. 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| subjects | Biological Products - adverse effects Breast Feeding - adverse effects Congresses as Topic Consensus Development Conferences as Topic Drug-Related Side Effects and Adverse Reactions - etiology Female Humans Infant Infant, Newborn Lactation Maternal Exposure - adverse effects Models, Biological Pregnancy Risk Assessment Risk Factors |
| title | Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary |
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