The EMEA, or European Medicines Evaluation Agency, recommendations referred to by the Deputy refer only to SSRI antidepressants containing paroxetine. The Committee for Human Medicinal Products, a scientific committee of the EMEA, is currently considering a review of all the other SSRIs and related antidepressants and I understand that a review of these issues is also ongoing in the US.
The CHMP review of paroxetine concluded in April 2004 and the committee issued its opinion. The next step will be for the EU Commission to issue its decision, taking account of the CHMP opinion. The CHMP opinion concluded that the benefit-risk ratio remains positive for paroxetine containing medicines in the treatment of adults but recommends changes to the product information for paroxetine on an EU-wide basis. First, a warning to reflect that paroxetine should not be used in children and adolescents. In the EU paroxetine is not authorised for use in this population. Data from clinical trials raised concerns regarding suicidal behaviour and hostility. Second, data from clinical trials have not adequately demonstrated efficacy in these age groups. Although paroxetine is not authorised for use in children and adolescents, doctors can prescribe this product for an individual patient if they feel it may be of benefit. However, they are advised to exercise caution. Alternative treatments for childhood depression, such as cognitive behavioural therapy, may be prescribed by child psychiatrists. Second, a warning to prescribers recommending close monitoring of patients at high risk of suicidal behaviour. These include patients with a known history of suicidal behaviour or suicidal thoughts prior to starting treatment and, possibly, young adults. Third, a recommendation that prescribers and patients should be warned regarding the occurrence of withdrawal reactions on stopping treatment. Generally, these are mild to moderate and self-limiting; however in some patients they may be severe and-or prolonged.
These recommendations were issued following a review of the existing data on paroxetine by medical experts from the member states. Ireland, via the IMB and its national experts, participated in this review and I am advised that these recommendations are considered appropriate on the basis of the data assessed. The CHMP will take further action on paroxetine if new data emerge which indicate that this is necessary. Health care professionals have been informed of the above issues by the relevant pharmaceutical companies and in the IMB's regular column in MIMS Ireland, a monthly publication which is designed as a prescribing guide for general practitioners.
