Japan - The Ministry of Health and Welfare has instructed domestic manufacturers and wholesalers of drugs containing phenylpropanolamine (PPA), a drug linked to haemorrhagic stroke in the United States, to revise the precautions statement of the package insert. This will now list hypertension and a history of cerebral haemorrhage as contraindications while drawing attention to the risk of haemorrhagic stroke.
This action follows a large-scale epidemiological survey conducted in the United States between 1994 and 1999 showing that women who use PPA as an appetite suppressant have a higher incidence of haemorrhagic stroke. The reason is not clear, but is believed to relate to the large doses used.
Reference: Pharma Japan, 1724, 4 December 2000.