Serious Reactions

For drugs that have been on the market longer, that are not marked with a black triangle, it is still important to send ADR reports for serious reactions. This is to maintain reassurance on their safety and allow comparison with newly introduced drugs within the same class. This is to maximise patient safety. This information is also used when drugs are considered for licensing for over the counter sale.

CSM Scotland is particularly keen to receive reports of reactions that are regarded as serious. The CSM has defined these as;

Fatal
Life threatening
Disabling
Incapacitating
Resulting in, or prolonging hospitalisation
These which are deemed by the reporter as medically significant

Other reactions that are serious include congenital abnormalities.

Reporters who are concerned about any reaction should make a report to the centre. If you are more interested in this topic the CSM has produced a list of some examples of serious reactions (PDF format ).