Healthcare professional reporting of adverse drug reactions: Areas of special interest

Although we monitor the adverse reactions associated with all medicines on the market, we have a number of areas of particular interest, as listed below.

Adverse reactions in children
We ask all suspected adverse reactions which occur in children to be reported regardless of whether the medicine is licensed for use in children.

Very little is known about the safe use of medicines in this age group as generally children are not exposed to medicines in clinical trials. Also many drugs that are routinely used to treat children are not actually licensed for use in this age group so it is particularly important to focus on the safety of medicines in children.

Adverse reactions in the elderly
We ask you to be particularly alert to suspected adverse reactions in the elderly, and to report them according to the reporting guidelines.

The elderly may be more susceptible to developing reactions, as they may metabolise medicines less effectively, and may be more sensitive to their effects. Hence for both pharmacokinetic and pharmacodynamic reasons, they may be more susceptible to developing reactions. It is therefore important to monitor the safety of medicines in this age group.

Delayed drug effects
We are interested in reactions which may appear months or even years after exposure, for example, cancers or retroperitoneal fibrosis. Please report any suspicion of such an association.

Congenital anomalies
If a baby is born with a congenital abnormality, or if a pregnancy results in a malformed aborted foetus, please report to us if you suspect it an adverse reaction to a medicine. Please include information about any medicine taken during the pregnancy, including self-medication.

Herbal remedies
Although some herbal medicines are licensed for use, there are many herbal remedies available from outlets other than pharmacies, or supplied by herbal practitioners which are not licensed. It is important that we monitor all herbal products to ensure their safety so please report suspected adverse reactions to any herbal remedy.

It is important that you provide us with as much information as possible about the remedy, including its ingredients, source or supplier, if known, and what the product was being used for. If the remedy was supplied by a herbal practitioner, their name and address would be useful. You may also wish to retain a sample of the product if the reaction is severe, in case we need to carry out further investigations.