How safe is my drug?

The European Medicine Agency (EMA) have produced a new website to provide all patients and healthcare professionals with immediate access to information on reported suspected side-effects for over 1700 licensed medicines.Furthermore, the new website allows patients and doctors to report adverse events themselves - directly.

The European Database of Suspected Adverse Drug Reaction Reports lists all nationally-authorised medicines and provides summary information on each of all reported cases. The report allows you to quickly find the drug you are interested in, shows the number of cases reported by age, sex and geography, allows you to see the types of adverse reactions reported by patients and their doctors.

For example, the reuslts show that for the smoking deterrant drug Champix, up to September 2014 there have been over 9,000 reported adverse events.6,720 of these affected 18 - 64 year olds and 4,591 patients were female. The biggest types of adverse events reported were psychiatric disorders, nervous system disorders and gastrointestinal disorders.

The types of adverse reactions reported are grouped to included categories such as:

  • Blood and lymphatic system disorders
  • Cardiac disorders,
  • Endocrine (hormone) disorders
  • etc

Each adverse reaction group is then further sub-divided into 'reported suspected reactions', for example, blood disorders might include anaemia or haemolysis. For Champix, for example the new site shows that doctors have reported 16 cases of anaemia.

This site provides a good insight for anyone who wants to know what side effects other patients have experienced from taking any particular medicine, and is a valuable source of information on the safety of these drugs. Of course, the site does not balance these adverse events with more positive outcome data on the health benefits, but that is not its purpose and could well be a development for the future.

A reduced level of haemoglobin, which carries oxygen in the blood. Anaemia causes tiredness, breathlessness and abnormally pale skin. Full medical glossary
A fluid that transports oxygen and other substances through the body, made up of blood cells suspended in a liquid. Full medical glossary
A substance produced by a gland in one part of the body and carried by the blood to the organs or tissues where it has an effect. Full medical glossary
relating to the intestines, the digestive tract between the stomach and the anus Full medical glossary
A watery or milky bodily fluid containing lymphocytes, proteins and fats. Lymph accumulates outside the blood vessels in the intercellular spaces of the body tiisues and is collected by the vessels of the lymphatic system. Full medical glossary
Vessels that carry lymphatic fluid, a fluid derived from the blood. Full medical glossary
The system that gathers and stores information and is in overall control of the body. The brain and spinal cord form the central nervous system. Full medical glossary
osteoarthritis Full medical glossary