Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients.

Rezaallah, Bita; Lewis, David John; Zeilhofer, Hans-Florian; Berg, Britt-Isabelle

Rezaallah, Bita; Lewis, David John; Zeilhofer, Hans-Florian; Berg, Britt-Isabelle.

Affiliation

Rezaallah B; 1 Department of Clinical Research, University of Basel, Basel, Switzerland.
Lewis DJ; 2 Patient Safety, Novartis Global Drug Development, Novartis Pharma Basel, Switzerland.
Zeilhofer HF; 2 Patient Safety, Novartis Global Drug Development, Novartis Pharma Basel, Switzerland.
Berg BI; 3 School of Health and Human Sciences, University of Hertfordshire, Hatfield, United Kingdom.

Ther Innov Regul Sci ; 53(1): 110-119, 2019 01.

Article in En | MEDLINE | ID: mdl-29714593

Subject(s)

Anticonvulsants/adverse effects; Cleft Lip/chemically induced; Cleft Palate/chemically induced; Adverse Drug Reaction Reporting Systems; Female; Health Personnel; Humans; Infant, Newborn; Maternal-Fetal Exchange; Patients; Pregnancy; Product Surveillance, Postmarketing; Risk; United States; United States Food and Drug Administration

Key words

antiepileptic drugs; cleft lip and palate; labeling; patient information leaflets; pregnancy outcomes; prescribing information; safety signal detection

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cleft Lip / Cleft Palate / Anticonvulsants Type of study: Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Female / Humans / Newborn / Pregnancy Country/Region as subject: America do norte Language: En Journal: Ther Innov Regul Sci Year: 2019 Document type: Article Affiliation country: Switzerland Country of publication: Switzerland

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