Vol. 403 No. 3
26 Mr. Allen asked the Minister for Health if his attention has been drawn to the report about suicide attempts among the users of the drug Prozac contained in the February 1990 edition of the American journal Psychiatry; if the drug is used in this country; and if he will make a statement on the matter.
Prozac is a product which contains the active substance fluoxetine and is used in the treatment of moderate to severe depression. In 1986, application for approval to market Prozac was made to the National Drugs Advisory Board, which is responsible for advising me on matters relating to the safety, quality and efficacy of drugs and medicines. Following detailed consideration of all the available documentation, the National Drugs Advisory Board recommended that authorisation be given to market Prozac and the marketing of this product was authorised in April 1988.
The product was the subject of post-marketing surveillance by the National Drugs Advisory Board for a period of 18 months after its introduction onto the market and the results of the surveillance noted that the side-effect profile did not indicate any untoward drug associated risks. The National Drugs Advisory Board obtained full details of the studies carried out in the United States together with expert psychiatric evaluation of the results of those studies. Following a thorough investigation, the board have concluded that the incidence of overall suicide in depression was, in fact, slightly reduced in patients on fluoxetine.
