§ Mr. AustinTo ask the Secretary of State for Health what assessment he has made of potential adverse health effects of phenylpropanolamine in proprietary medicines. [140803]
§ Ms StuartMinisters asked the Committee on Safety of Medicines (CSM), the expert advisory body to the licensing authority to consider the possible increased risk of haemorrhagic stroke associated with medicines containing phenylpropanolamine (PPA) at its meeting on 8 November 2000. This immediately followed action by the Food and Drug Administration (FDA) in the United States of America, which had asked for withdrawal of medicines containing phenylpropanolamine (PPA), on the basis of the Yale Haemorrhagic Stroke Project.
The Committee on Review of Medicines (CRM) in 1984, and the CSM in 1995, had previously considered the issue and as a result the maximum doses were reduced, and warnings and contraindications were strengthened. Following a preliminary review, the CSM concluded that the evidence of a link between haemorrhagic stroke and PPA is weak and mainly associated with uses that are not licensed in the United Kingdom. The CSM recognised that PPA products are used differently in the UK: appetite suppressants containing PPA, which have been linked to stroke in young women in the USA, are not available in the UK. Over the counter cold and flu remedies on the market in the UK have a lower maximum daily dose (100 mg) than similar products in the USA (150 mg).
PPA-containing products should not be used by certain groups of patients, such as those with high blood pressure or heart disease. These warnings and contraindications are clearly stated on the packaging and patient information leaflets.
The Department sent out a letter on 9 November from the chairman of the CSM to all general practitioners and pharmacists making them aware of the current situation, and reminding them of particular contraindications and warnings associated with PPA-containing products.
A further detailed evaluation has been carried out to investigate fully the implications for use of PPA in the UK. This was considered by the CSM at its meeting on 23 November. The CSM confirmed the view taken previously and agreed that the advice given then should stand. They advised that there was no need for further urgent communication with health professionals. Minor 635W amendments to product information to reinforce the existing warnings could be carried out on a non-urgent basis.
The MCA continually monitor the safety of PPA-containing products, as for all medicines.