Summary

On 8 November 2000, the Committee on Safety of Medicines (CSM) considered and reviewed the evidence from the Haemorrhagic Stroke Project in the USA regarding the risk of haemorrhagic stroke in subjects exposed to phenylpropanolamine (PPA).  The CSM reached the conclusion that withdrawal of PPA-containing products was not necessary in the UK.

In this editorial, three research fellows from the DSRU discussed how this issue highlights the need for continued monitoring of the safety of over-the-counter (OTC) products.  The Haemorrhagic Stroke Project results demonstrate that OTC products may be far from safe and it is important that risks associated with such products are continually evaluated for safety.  Pharmacists are ideally placed to identify adverse events suspected to be caused by use of OTC products alone, or in combination with other medicines, and should be encouraged to make use of available resources to record interventions and facilitate reporting to the regulatory authorities.