Pregnancy outcomes following exposure to onabotulinumtoxinA
Purpose To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database. Methods The Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, i...
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| Veröffentlicht in: | Pharmacoepidemiology and drug safety 2016-02, Vol.25 (2), p.179-187 |
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| creator | Brin, Mitchell F. Kirby, Russell S. Slavotinek, Anne Miller-Messana, Mary Ann Parker, Lori Yushmanova, Irina Yang, Huiying |
| description | Purpose
To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.
Methods
The Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.
Results
Of 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received |
| doi_str_mv | 10.1002/pds.3920 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5063122</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1780515355</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5090-61bbc1225806e4c6c936375e018e0f76cffb4d995b07ebad61b203cca821c98b3</originalsourceid><addsrcrecordid>eNp1kW9rFDEQh0Ox2D8KfgJZ8I1vtk6SS3aDIJTTtpaihSoF34RsbvZMu5ucyW579-3N0etZBV9NYB6emcmPkFcUjigAe7eYpSOuGOyQfQpKlVSI6tn6LXhZC6n2yEFKNwC5pybPyR6TkgtWyX3y_jLi3BtvV0UYBxt6TEUbui7cOz8vcLkIaYxYDKEI3jRhGDvnx34IS-ePX5Dd1nQJX27qIfl-8unb9Ky8-Hr6eXp8UVoBCkpJm8ZSxkQNEidWWsUlrwQCrRHaStq2bSYzpUQDFTZmlnkG3FpTM2pV3fBD8uHBuxibHmcW_RBNpxfR9SaudDBO_93x7qeehzstQPI8OAvebgQx_BoxDbp3yWLXGY9hTJpWNQgquBAZffMPehPG6PN5mZJQMZadf4Q2hpQitttlKOh1IjonoteJZPT10-W34GMEGSgfgHvX4eq_In358Woj3PAuDbjc8ibealnlf9XXX0719fRqyuCc6x_8NxZ8pMM</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1760722063</pqid></control><display><type>article</type><title>Pregnancy outcomes following exposure to onabotulinumtoxinA</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Brin, Mitchell F. ; Kirby, Russell S. ; Slavotinek, Anne ; Miller-Messana, Mary Ann ; Parker, Lori ; Yushmanova, Irina ; Yang, Huiying</creator><creatorcontrib>Brin, Mitchell F. ; Kirby, Russell S. ; Slavotinek, Anne ; Miller-Messana, Mary Ann ; Parker, Lori ; Yushmanova, Irina ; Yang, Huiying</creatorcontrib><description>Purpose
To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.
Methods
The Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.
Results
Of 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received <50U, 14.6% 50U to <100U, 27.7% 100U to <200U, and 17.5% ≥200U. Among 146 cases with known maternal age, 47.9% were ≥35 years. Most (96.0%) fetal exposures occurred during/before the first trimester. Of the 137 prospective cases (139 fetuses), 110 (79.1%) were live births; 29 (20.9%; 95% CI, 14.0–30.0%) ended in fetal loss (21 spontaneous, 8 induced abortions). Among live births, 106 (96.4%) were normal, with four abnormal birth outcomes (1 major fetal defect, 2 minor fetal malformations, 1 birth complication), giving a 2.7% (3/110; 95% CI, 0.6–8.0%) prevalence rate for overall fetal defects.
Conclusions
A 24‐year retrospective review of the Allergan safety database shows that the prevalence of fetal defects in onabotulinumtoxinA‐exposed mothers before/during pregnancy (2.7%) is comparable with background rates in the general population. Pregnancy outcome monitoring in onabotulinumtoxinA‐exposed women continues. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.3920</identifier><identifier>PMID: 26635276</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Abnormalities, Drug-Induced - diagnosis ; Abnormalities, Drug-Induced - epidemiology ; Abortion, Spontaneous - chemically induced ; Abortion, Spontaneous - diagnosis ; Abortion, Spontaneous - epidemiology ; Acetylcholine Release Inhibitors - adverse effects ; Adult ; Adverse Drug Reaction Reporting Systems - trends ; Birth defects ; Botulinum Toxins, Type A - adverse effects ; Databases, Factual - trends ; Drug therapy ; Female ; fetal defects ; Humans ; Live Birth - epidemiology ; Miscarriage ; onabotulinumtoxinA ; Original Report ; Original Reports ; pharmacoepidemiology ; Pharmacology ; Pregnancy ; Pregnancy Outcome - epidemiology ; Prenatal Exposure Delayed Effects - chemically induced ; Prenatal Exposure Delayed Effects - diagnosis ; Prenatal Exposure Delayed Effects - epidemiology ; Prospective Studies ; Retrospective Studies</subject><ispartof>Pharmacoepidemiology and drug safety, 2016-02, Vol.25 (2), p.179-187</ispartof><rights>2015 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</rights><rights>Copyright © 2016 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5090-61bbc1225806e4c6c936375e018e0f76cffb4d995b07ebad61b203cca821c98b3</citedby><cites>FETCH-LOGICAL-c5090-61bbc1225806e4c6c936375e018e0f76cffb4d995b07ebad61b203cca821c98b3</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%2Fpds.3920$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.3920$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26635276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brin, Mitchell F.</creatorcontrib><creatorcontrib>Kirby, Russell S.</creatorcontrib><creatorcontrib>Slavotinek, Anne</creatorcontrib><creatorcontrib>Miller-Messana, Mary Ann</creatorcontrib><creatorcontrib>Parker, Lori</creatorcontrib><creatorcontrib>Yushmanova, Irina</creatorcontrib><creatorcontrib>Yang, Huiying</creatorcontrib><title>Pregnancy outcomes following exposure to onabotulinumtoxinA</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>Purpose
To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.
Methods
The Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.
Results
Of 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received <50U, 14.6% 50U to <100U, 27.7% 100U to <200U, and 17.5% ≥200U. Among 146 cases with known maternal age, 47.9% were ≥35 years. Most (96.0%) fetal exposures occurred during/before the first trimester. Of the 137 prospective cases (139 fetuses), 110 (79.1%) were live births; 29 (20.9%; 95% CI, 14.0–30.0%) ended in fetal loss (21 spontaneous, 8 induced abortions). Among live births, 106 (96.4%) were normal, with four abnormal birth outcomes (1 major fetal defect, 2 minor fetal malformations, 1 birth complication), giving a 2.7% (3/110; 95% CI, 0.6–8.0%) prevalence rate for overall fetal defects.
Conclusions
A 24‐year retrospective review of the Allergan safety database shows that the prevalence of fetal defects in onabotulinumtoxinA‐exposed mothers before/during pregnancy (2.7%) is comparable with background rates in the general population. Pregnancy outcome monitoring in onabotulinumtoxinA‐exposed women continues. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</description><subject>Abnormalities, Drug-Induced - diagnosis</subject><subject>Abnormalities, Drug-Induced - epidemiology</subject><subject>Abortion, Spontaneous - chemically induced</subject><subject>Abortion, Spontaneous - diagnosis</subject><subject>Abortion, Spontaneous - epidemiology</subject><subject>Acetylcholine Release Inhibitors - adverse effects</subject><subject>Adult</subject><subject>Adverse Drug Reaction Reporting Systems - trends</subject><subject>Birth defects</subject><subject>Botulinum Toxins, Type A - adverse effects</subject><subject>Databases, Factual - trends</subject><subject>Drug therapy</subject><subject>Female</subject><subject>fetal defects</subject><subject>Humans</subject><subject>Live Birth - epidemiology</subject><subject>Miscarriage</subject><subject>onabotulinumtoxinA</subject><subject>Original Report</subject><subject>Original Reports</subject><subject>pharmacoepidemiology</subject><subject>Pharmacology</subject><subject>Pregnancy</subject><subject>Pregnancy Outcome - epidemiology</subject><subject>Prenatal Exposure Delayed Effects - chemically induced</subject><subject>Prenatal Exposure Delayed Effects - diagnosis</subject><subject>Prenatal Exposure Delayed Effects - epidemiology</subject><subject>Prospective Studies</subject><subject>Retrospective Studies</subject><issn>1053-8569</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kW9rFDEQh0Ox2D8KfgJZ8I1vtk6SS3aDIJTTtpaihSoF34RsbvZMu5ucyW579-3N0etZBV9NYB6emcmPkFcUjigAe7eYpSOuGOyQfQpKlVSI6tn6LXhZC6n2yEFKNwC5pybPyR6TkgtWyX3y_jLi3BtvV0UYBxt6TEUbui7cOz8vcLkIaYxYDKEI3jRhGDvnx34IS-ePX5Dd1nQJX27qIfl-8unb9Ky8-Hr6eXp8UVoBCkpJm8ZSxkQNEidWWsUlrwQCrRHaStq2bSYzpUQDFTZmlnkG3FpTM2pV3fBD8uHBuxibHmcW_RBNpxfR9SaudDBO_93x7qeehzstQPI8OAvebgQx_BoxDbp3yWLXGY9hTJpWNQgquBAZffMPehPG6PN5mZJQMZadf4Q2hpQitttlKOh1IjonoteJZPT10-W34GMEGSgfgHvX4eq_In358Woj3PAuDbjc8ibealnlf9XXX0719fRqyuCc6x_8NxZ8pMM</recordid><startdate>201602</startdate><enddate>201602</enddate><creator>Brin, Mitchell F.</creator><creator>Kirby, Russell S.</creator><creator>Slavotinek, Anne</creator><creator>Miller-Messana, Mary Ann</creator><creator>Parker, Lori</creator><creator>Yushmanova, Irina</creator><creator>Yang, Huiying</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>BSCLL</scope><scope>24P</scope><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>7TK</scope><scope>K9.</scope><scope>7U7</scope><scope>C1K</scope><scope>5PM</scope></search><sort><creationdate>201602</creationdate><title>Pregnancy outcomes following exposure to onabotulinumtoxinA</title><author>Brin, Mitchell F. ; Kirby, Russell S. ; Slavotinek, Anne ; Miller-Messana, Mary Ann ; Parker, Lori ; Yushmanova, Irina ; Yang, Huiying</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5090-61bbc1225806e4c6c936375e018e0f76cffb4d995b07ebad61b203cca821c98b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Abnormalities, Drug-Induced - diagnosis</topic><topic>Abnormalities, Drug-Induced - epidemiology</topic><topic>Abortion, Spontaneous - chemically induced</topic><topic>Abortion, Spontaneous - diagnosis</topic><topic>Abortion, Spontaneous - epidemiology</topic><topic>Acetylcholine Release Inhibitors - adverse effects</topic><topic>Adult</topic><topic>Adverse Drug Reaction Reporting Systems - trends</topic><topic>Birth defects</topic><topic>Botulinum Toxins, Type A - adverse effects</topic><topic>Databases, Factual - trends</topic><topic>Drug therapy</topic><topic>Female</topic><topic>fetal defects</topic><topic>Humans</topic><topic>Live Birth - epidemiology</topic><topic>Miscarriage</topic><topic>onabotulinumtoxinA</topic><topic>Original Report</topic><topic>Original Reports</topic><topic>pharmacoepidemiology</topic><topic>Pharmacology</topic><topic>Pregnancy</topic><topic>Pregnancy Outcome - epidemiology</topic><topic>Prenatal Exposure Delayed Effects - chemically induced</topic><topic>Prenatal Exposure Delayed Effects - diagnosis</topic><topic>Prenatal Exposure Delayed Effects - epidemiology</topic><topic>Prospective Studies</topic><topic>Retrospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brin, Mitchell F.</creatorcontrib><creatorcontrib>Kirby, Russell S.</creatorcontrib><creatorcontrib>Slavotinek, Anne</creatorcontrib><creatorcontrib>Miller-Messana, Mary Ann</creatorcontrib><creatorcontrib>Parker, Lori</creatorcontrib><creatorcontrib>Yushmanova, Irina</creatorcontrib><creatorcontrib>Yang, Huiying</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brin, Mitchell F.</au><au>Kirby, Russell S.</au><au>Slavotinek, Anne</au><au>Miller-Messana, Mary Ann</au><au>Parker, Lori</au><au>Yushmanova, Irina</au><au>Yang, Huiying</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pregnancy outcomes following exposure to onabotulinumtoxinA</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2016-02</date><risdate>2016</risdate><volume>25</volume><issue>2</issue><spage>179</spage><epage>187</epage><pages>179-187</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><abstract>Purpose
To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.
Methods
The Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.
Results
Of 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received <50U, 14.6% 50U to <100U, 27.7% 100U to <200U, and 17.5% ≥200U. Among 146 cases with known maternal age, 47.9% were ≥35 years. Most (96.0%) fetal exposures occurred during/before the first trimester. Of the 137 prospective cases (139 fetuses), 110 (79.1%) were live births; 29 (20.9%; 95% CI, 14.0–30.0%) ended in fetal loss (21 spontaneous, 8 induced abortions). Among live births, 106 (96.4%) were normal, with four abnormal birth outcomes (1 major fetal defect, 2 minor fetal malformations, 1 birth complication), giving a 2.7% (3/110; 95% CI, 0.6–8.0%) prevalence rate for overall fetal defects.
Conclusions
A 24‐year retrospective review of the Allergan safety database shows that the prevalence of fetal defects in onabotulinumtoxinA‐exposed mothers before/during pregnancy (2.7%) is comparable with background rates in the general population. Pregnancy outcome monitoring in onabotulinumtoxinA‐exposed women continues. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>26635276</pmid><doi>10.1002/pds.3920</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Abnormalities, Drug-Induced - diagnosis Abnormalities, Drug-Induced - epidemiology Abortion, Spontaneous - chemically induced Abortion, Spontaneous - diagnosis Abortion, Spontaneous - epidemiology Acetylcholine Release Inhibitors - adverse effects Adult Adverse Drug Reaction Reporting Systems - trends Birth defects Botulinum Toxins, Type A - adverse effects Databases, Factual - trends Drug therapy Female fetal defects Humans Live Birth - epidemiology Miscarriage onabotulinumtoxinA Original Report Original Reports pharmacoepidemiology Pharmacology Pregnancy Pregnancy Outcome - epidemiology Prenatal Exposure Delayed Effects - chemically induced Prenatal Exposure Delayed Effects - diagnosis Prenatal Exposure Delayed Effects - epidemiology Prospective Studies Retrospective Studies |
| title | Pregnancy outcomes following exposure to onabotulinumtoxinA |
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