§ Mr. Wareing
To ask the Secretary of State for Social Services what information he has on the adverse side effects of the drug fluvoxamine maleate; if any fatalities resulting from its use have been reported to him; if he proposes to take any action to restrict its use; and if he will make a statement.
§ Mr. Newton
[holding answer 10 June 1988]:Reports by doctors of suspected adverse reactions to fluvoxamine maleate were summarised by the Committee on Safety of Medicines in "Current Problems 22", issued to doctors in May (a copy is in the Library). To date the committee has received six reports of suspected reactions to fluvoxamine where the patient has died from that event. However, subsequent analysis suggests that while two of the deaths may be attributable to recognised side effects of other drugs, none appears to have been caused by fluvoxamine. The manufacturers of fluvoxamine were informed and have written to all doctors to tell them of these findings.133W
After discussion with the licensing authority, Duphar Laboratories has amended the data sheet for fluvoxamine to limit the indications for this drug to "the treatment of depressive illness", and to contain an up-to-date description of the known side effects. The revised data sheet was sent to general practitioners in April. While fluvoxamine has a different mode of action to most other anti-depressants—and therefore a different adverse reactions profile—there is no evidence that the drug is less safe than alternative anti-depressants.
Expected commencement date Section 2(i)—(2) Retirement Allowance April 1989 Section 4 Young persons 12 September 1988 Section 5 Annual Review of Child Benefit No commencement is planned Section 6 Short-term Benefits 2 October 1988 Section 7 Unemployment Benefit and Occupational Pension 1 January 1989