Antipsychotics: risk of extrapyramidal effects or withdrawal symptoms in newborns
- Medicines and Healthcare products Regulatory Agency
- 7 September 2011
- Therapeutic area:
- Obstetrics, gynaecology and fertility and Psychiatry
Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
Article date: September 2011
There are insufficient data to determine the size of the risk or any difference in risk between classes of antipsychotics or between individual antipsychotics.
UK product information for all antipsychotics will be updated to include consistent information about this risk.
Advice for healthcare professionals:
- following maternal use of antipsychotics in the third trimester, examine newborns for symptoms which may include: agitation; hypertonia; hypotonia; tremor; somnolence; feeding problems; and respiratory distress
- symptoms may vary in severity and duration, and they should be monitored and treated (if necessary) on an individual basis
- expectant mothers should be counselled about the benefits and risks of antipsychotic treatment during pregnancy
Please report suspected adverse events related to the use of antipsychotics during pregnancy through the Yellow Card Scheme at www.yellowcard.gov.uk
Report from the European Pharmacovigilance Working Party
US Food and Drug Administration safety information on antipsychotic drugs and treatment during pregnancy
BNF section 4.2.1 Antipsychotic drugs
Article citation: Drug Safety Update Sept 2011, vol 5 issue 2: A2.
Published: 7 September 2011