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Psychiatric Bulletin (2007) 31: 191-192. doi: 10.1192/pb.31.5.191c
© 2007 The Royal College of Psychiatrists
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Correspondence

Medication side-effects - informing the MHRA

June Raine, Director of Vigilance and Risk Management of Medicines

Medicines and Healthcare Products Regulatory Agency (MHRA), London SW8 5NQ, email: press.office{at}mhra.gsi.gov.uk

Lyall et al (Psychiatric Bulletin, January 2007, 31, 16-18) described how two patients with psychotic illnesses developed stuttering while being treated with clozapine. The Government’s Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for ensuring that medicines are acceptably safe. It takes action in relation to safety concerns and changes in the balances of risks and benefits. There is no mention by Lyall et al of informing the MHRA about the stuttering side-effect. I would like to urge readers of Psychiatric Bulletin to report to the MHRA any side-effects, suspected or otherwise, caused by a medicine through the Yellow Card Scheme. This scheme plays an essential role in protecting public health by helping the MHRA to monitor the safety of medicines on the market. Psychiatrists and other healthcare professionals can complete a form online at www.yellowcard.gov.uk, or on a Yellow Card available in the British National Formulary, or directly from the MHRA (by telephoning 0800 731 6789). I would also urge readers to encourage patients to report any side-effects. With these reports, we can actively look for signs of potential safety issues requiring further investigation.

Reporting of adverse drug reactions is the professional duty of all healthcare professionals. The continued success of the Yellow Card Scheme depends on the continued support of health professionals and patients in completing Yellow Cards. We encourage Yellow Card reports from patients, but it is also vitally important that we continue to receive reports from psychiatrists and other health professionals.





This Article
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Right arrow Articles by Raine, J.


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