Drug safety is very much on the agenda in the UK, with the government’s Early Access to Medicines Scheme unveiled to great industry acclaim earlier this year. The scheme allows patients with serious illness to gain access to drugs before they are approved, with lobbyists making much of the popular benefit of ‘greater choice’.
A seven-year observational study has recently reported on the impact on babies of antipsychotic medication taken during pregnancy. The results provide pause for thought.
Apart from raising concern about the use of high doses of antipsychotics in this context, they also raise a question about the wider issue of drug safety – when even licensed drugs can yield such unexpected results, what hope for drugs which are being promoted and used off licence?
The study, conducted by the Monash Alfred Psychiatry Research Centre and Monash University in Australia, showed that the use of mood stabilisers or high doses of antipsychotics during pregnancy increased the need for special care among newborns, with 43% of babies placed in Neonatal Intensive Care Units (NICU) or Special Care Nurseries (SCN) – almost three times the national average.
Aside from increased need for specialist post-natal care, 18% of such babies were born prematurely, 37% showed signs of respiratory distress and 15% developed withdrawal symptoms.
The investigators commented on the dearth of research in this area, with lack of data making it difficult to provide informed advice to expectant mothers on drug safety.
Noting this deficit, in 2005 the Monash Alfred Psychiatry Research Centre established a National Register of Antipsychotic Medications in Pregnancy (NRAMP), recruiting women from all around Australia. A total of 147 women were interviewed every six weeks during pregnancy and followed up until their babies were one year old.
Around 25% of people in the UK experience depression over the course of a year, with women more likely to suffer than men. Women have higher rates of anxiety and there is roughly equal distribution between the sexes with schizophrenia and bipolar disorder. These results, then, may apply to a significant proportion of the population.
On the positive side, the research has shown there are no clear associations with congenital abnormalities associated with antipsychotic drugs and, on top of this, clinicians may now be better prepared to address potential problems for newborns whose mothers are taking medication.
No drug comes without side effects and it is incumbent on government regulators to go to every possible length to protect the sick and vulnerable from such effects outweighing the benefits. Let us hope that the prevailing trend towards medicating first, assessing later will not lead to future harm.
Written by Jacqui Hogan