Intended for healthcare professionals


Monitoring the safety of over the counter drugs

BMJ 2001; 323 doi: (Published 29 September 2001) Cite this as: BMJ 2001;323:706

We need a better way than spontaneous reports

  1. David Clark, senior lecturer,
  2. Deborah Layton, research pharmacist,
  3. Saad A W Shakir, director
  1. Department of Pharmacology, University of Otago, Dunedin, New Zealand
  2. Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA

    Last year the Food and Drug Administration in the United States recommended that phenylpropanolamine be removed from non-prescription and prescription medicines and that pharmaceutical companies voluntarily discontinue products containing phenylpropanolamine. This was in response to a case-control study by the Yale haemorrhagic stroke project investigators designed to determine the risk of haemorrhagic stroke in people exposed to phenylpropanolamine.1 Though this action was not followed in the United Kingdom, because the market conditions for phenylpropanolamine are different, the findings of the haemorrhagic stroke project highlight the need for continued monitoring of the safety of non-prescription medicines.

    In the United States formulations of phenylpropanolamine contain up to 150 mg of a racemic mixture of two enantiomers of (±)-norephedrine,2 and withdrawal of appetite suppressants and cough and cold preparations containing phenylpropanolamine may well have been an appropriate response to the haemorrhagic stroke project data. In Europe the licensed maximum daily dose in non-prescription cough and cold remedies is lower (100 mg), and appetite suppressants containing phenylpropanolamine are not available in the United Kingdom. …

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