The Pharmaceutical Journal
Vol 269 No 7209 p149
3 August 2002

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Social Audit (www.socialaudit.org.uk)
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SSRI withdrawal reactions highlighted

The Committee on Safety of Medicines and the Medicines Control Agency have received more reports of withdrawal reactions associated with the selective serotonin reuptake inhibitor paroxetine (Seroxat) than with any other drug.

Campaigning group Social Audit has reviewed data which it obtained from the CSM last month. It found that SSRIs account for five of the top six drugs for which such reactions have been reported. A total of 1,281 reports linking paroxetine and withdrawal reactions have been received by the CSM. Following paroxetine is venlafaxine (Efexor), which accounts for 272 reports. Charles Medawar, chief executive of Social Audit, has written to doctors highlighting the level of withdrawal reactions reported.

A spokesman for the MCA acknowledged that data had been supplied to Social Audit, but added that information on how to interpret the data had also been supplied, which Mr Medawar had failed to include in his letter to doctors. "The reporting of a reaction does not necessarily mean that the drug caused the problem and therefore these reactions should not be used as a list of side effects for the medicine to which it refers." He added that reporting rates are influenced by the seriousness of the suspected reaction, its ease of recognition, the extent of use of a particular drug and also by publicity about a drug. "Numerical comparisons should not be made between reactions associated with different drugs on the basis of this information. Comparisons can be misleading unless they take account of wide a number of factors," he said.

Mr Medawar invites comments from doctors on the warnings that should be included in the summary of product characteristics and patient information leaflet for SSRIs and suggests that prescribing advice should include information about withdrawal symptoms.

However, the MCA pointed out that the product information for paroxetine and other SSRIs does contain warnings about withdrawal symptoms. "Prescribers have been reminded of the need to taper dosing when withdrawing from treatment on two occasions via Current Problems in Pharmacovigilance in 1993 and 2000. In addition, the British National Formulary carries a clear warning on this issue," he said.

Mr Medawar also states in his letter to doctors that the CSM will shortly be considering reports of withdrawal reactions from patients for the first time. This, says the MCA, is incorrect. Patient reports collected by the charity MIND have been reviewed by the CSM in the past. However, the MCA does not currently have the means to collect patient reports systematically.