Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. The MHRA continuously monitors the safety of all medicines on the market in the United Kingdom and seeks independent expert advice from the CHM on important new safety issues.
The Yellow Card Scheme collects information relating to suspected adverse drug reactions, which include both serious and non-serious effects which a doctor or patient suspects may have been due to a medicine. The MHRA has received a total of 593 suspected spontaneous ADR reports in association with citalopram between 1 January 2016 and 31 December 2017. This number includes reports received directly from healthcare professionals, patients and indirectly through pharmaceutical companies which have a legal obligation to report suspected ADRs. The number of reports received directly from the National Health Service cannot be determined.
The MHRA does not hold information on deterioration of health. Each ADR report contains information on an ADR at a specific point in time, rather than a deterioration of health over a period of time, and should therefore not be interpreted as a report of a deterioration of a patient's health.
The inclusion of a particular ADR in a report does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have, or it had a close temporal relationship to the administration of the suspect drug. The fact that symptoms occur after a treatment does not necessarily mean that they have been caused by the drug itself, as underlying illnesses and other conditions may be responsible.
Citalopram is an antidepressant belonging to the class of medicines known as selective serotonin reuptake inhibitors. Citalopram is an effective medicine for the treatment of depression. Information about possible side-effects associated with treatment are provided in the product information which is available to all prescribers and patients. Data is evaluated as it emerges and where necessary regulatory action is taken and communicated to healthcare professionals and the information for patients is updated.