Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients.
Bita RezaallahDavid John LewisHans-Florian ZeilhoferBritt-Isabelle BergPublished in: Therapeutic innovation & regulatory science (2018)
There is statistical disproportionality in individual case safety reports indicative of an increased risk of CL/P with 12 antiepileptic drugs studied. More studies are required to explore the association between in utero exposure to antiepileptic drugs and the risk of CL/P. There are inconsistencies between the UK and US safety labels. CL/P associated with antiepileptic drugs is an important topic and requires providing inclusive, unbiased, up-to-date information to prescribers and women of childbearing age.
Keyphrases
- end stage renal disease
- ejection fraction
- chronic kidney disease
- newly diagnosed
- health information
- emergency department
- prognostic factors
- peritoneal dialysis
- polycystic ovary syndrome
- pregnant women
- patient reported outcomes
- insulin resistance
- skeletal muscle
- social media
- patient reported
- cervical cancer screening