The impact of European regulatory policies on psychotropic drug prescribing patterns.

Thanks to their alleged better tolerability atypical or second-generation antipsychotic drugs (SGA) have gained a considerable fraction of the market at the expense of the classical antipsychotics. The massive advertising of SGA focussed the doubtful reduction of extra-pyramidal side effects (EPS) overlooking the information about the cardiovascular risk induced by SGA. This also led to extensive off-label use as the control of behavioural symptoms associated with dementia in elderly patients. Although the European Medicine Agency (EMEA) eventually warned physicians and patients of the risk associated with SGA use in this area, the regulatory system has some responsibility in this situation. No added therapeutic value is required for new drugs to be approved for the market. They are only evaluated for their own quality, efficacy and safety with no comparison with available alternative treatments. This implies that new drugs may, in fact, be potentially less effective or less safe than other drugs currently in use.