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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.
YCC Scotland is particularly keen to receive reports of reactions
that are regarded as serious. The MHRA 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 possible adverse drug reaction
should make a yellow card report.
If you are more interested in this topic see the list of some examples of serious
reactions (PDF format ) or check the MHRA website regarding: is an adverse reaction serious?
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