MHRA introduces pregnancy prevention programme for prescribing of topiramate
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recommends that topiramate is contraindicated in pregnancy and in women of child-bearing potential unless the conditions of a pregnancy prevention programme are fulfilled.[99] This aims to ensure that all women of child-bearing potential are using highly effective contraception, have a pregnancy test to exclude pregnancy before starting topiramate, and are aware of the risks from use of the drug.
Topiramate is associated with a higher risk of congenital malformations and a high prevalence of babies being born small for gestational age.[99] Topiramate may be also associated with an approximately 2 to 3 times increased risk of intellectual disability, autistic spectrum disorders, and attention deficit hyperactivity disorder.[100]
The European Medicines Agency (EMA) supports these restrictions on the use of topiramate, and also recommends that a pregnancy prevention programme is in place before prescribing topiramate.[101]
Summary
Definition
History and exam
Key diagnostic factors
- presence of risk factors
- withdrawal
- tolerance
- increased/decreased liver size, jaundice, ascites
Other diagnostic factors
- insomnia
- erectile dysfunction
- nicotine-use disorder
- gastrointestinal distress
- muscle cramps, pain, tenderness, altered sensory perception
- hypertension and tachycardia
- impaired nutritional status
- broad-based gait
Risk factors
- family history of alcohol-use disorder
- antisocial behaviour (pre-morbid)
- high trait anxiety level
- lack of facial flushing on exposure to alcohol
- low responsivity to the effects of alcohol
- history of gastric bypass
Diagnostic investigations
1st investigations to order
- diagnostic interview
- alcohol level (breath and blood)
- Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)
Investigations to consider
- carbohydrate-deficient transferrin (CDT)
- gamma glutamyl transpeptidase (gamma-GT), alanine aminotransferase (ALT), aspartate aminotransferase (AST)
- FBC
- urinary ethyl glucuronide
Treatment algorithm
at-risk drinking
alcohol-use disorder: non-pregnant adult with no concurrent opioid use or mental health diagnosis
alcohol-use disorder: non-pregnant adult with concurrent opioid use
alcohol-use disorder: non-pregnant adult with concurrent mental health diagnosis
alcohol-use disorder: non-pregnant adolescent
alcohol-use disorder: pregnant
Contributors
Authors
Elisabeth Poorman, MD, MPH
Assistant Professor of Medicine
Department of Medicine
University of Illinois Chicago
Chicago
IL
Disclosures
EP declares that she has no conflicting interests.
Marlene Martin, MD
Associate Professor of Clinical Medicine
Director, Addiction Care Team
San Francisco General Hospital
University of California, San Francisco
San Francisco
CA
Disclosures
MM is a board member for the National Harm Reduction Coalition and has done consultancy work for the Society of Hospital Medicine.
Sarah Messmer, MD
Assistant Professor of Clinical Medicine and Pediatrics
University of Illinois Chicago
Chicago
IL
Disclosures
SM declares that she has no conflicting interests.
Acknowledgements
Dr Elisabeth Poorman, Dr Marlene Martin, and Dr Sarah Messmer would like to gratefully acknowledge Dr Colin Drummond, Dr Julie R. Pittman, Dr Philip H. Chung, Dr Robert M. Swift, and Dr Lorenzo Leggio, previous contributors to this topic.
Disclosures
CD, JRP, PHC, and RMS declare that they have no competing interests. LL is an author of a reference cited in this topic.
Peer reviewers
Paul S. Haber, MD
Royal Prince Alfred Hospital and Discipline of Medicine
University of Sydney
Sydney
Australia
Disclosures
PSH is an author of a reference cited in this topic.
Roberta Agabio, MD
Bernard B. Brodie Department of Neuroscience
University of Cagliari
Cagliari
Italy
Disclosures
RA is an author of a number of references cited in this topic.
Differentials
- Other psychiatric disorders
- Other substance use disorders (especially sedatives)
More DifferentialsGuidelines
- International statistical classification of diseases and related health problems, 11th ed. (ICD-11)
- Diagnostic and statistical manual of mental disorders, 5th ed., text revision (DSM-5-TR)
More GuidelinesPatient information
Alcohol-use disorder
More Patient informationCalculators
Alcohol Consumption Screening AUDIT Questionnaire
More Calculators- Log in or subscribe to access all of BMJ Best Practice
Use of this content is subject to our disclaimer