The Pharmaceutical Journal Vol 265 No 7125p810
December 02, 2000 Clinical
No UK ban for phenylpropanolamine
Phenylpropanolamine will not be banned in the United Kingdom. After detailed consideration of the available evidence, the Committee on Safety of Medicines (CSM) concluded on November 23 that evidence of a link between the drug and haemorrhagic stroke is weak and mainly associated with uses that are not licensed in the UK. The conclusion backs the CSM's initial evaluation (PJ, November 18, p748).
The only additional recommendation that the CSM has made is that the Medicines Control Agency should work closely with manufacturers to improve existing product information on packs and patient information leaflets for products containing phenylpropanolamine.
The CSM stresses that phenylpropanolamine use in the UK is different from that in the United States. Appetite suppressants, which have been linked with stroke, are not available in the UK and over-the-counter cold and 'flu remedies have a lower maximum daily dose (100mg in the UK compared with 150mg in the US).
However, previous reports that phenylpropanolamine used in the US and Europe are different compounds (PJ, November 11, p709) have been withdrawn. In a letter to The Journal (see p817), Professor Tony Moffat (chief scientist, Royal Pharmaceutical Society), Mr Sean Sweetman (editor, Martindale) and Ms Marie Rabouhans (editor in chief, British Pharmacopoeia) say that the drugs are the same and that differences currently indicated in the British Pharmacopoeia and Martindale will be corrected in the next editions of both books.
Citation: The Pharmaceutical JournalURI: 20003683
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