Pharmaceutical products are used to cure, prevent and treat illnesses, and at some point in our lives every one of us probably uses them: vaccines that prevent diseases, antibiotics that treat infections or analgesics that relieve pain. Many people also use dietary supplements, such as vitamins, to boost their wellbeing. Medication can always cause adverse reactions, even though most people will not notice them because the majority of users do not experience significant reactions.
Adverse reactions are carefully monitored in clinical trials before a drug enters the market, and after that they remain under constant monitoring throughout the life cycle of the drug. When a drug becomes available for more widespread use, suspected adverse reactions are reported to authorities and pharmaceutical companies, and they are also discussed in scientific journal articles. The marketing authorisation holder has an obligation to collaborate with the authorities in collecting data on adverse reactions and in analysing their incidence rate and the relationship between the reaction and the patient’s medication.
Adverse reactions are carefully monitored in clinical trials before a drug enters the market, and after that they remain under constant monitoring throughout the life cycle of the drug.
This is called assessment of the benefit-risk ratio. If the new benefit-risk ratio differs from the original assessment, the change is reflected in the terms of the marketing authorisation, or the marketing authorisation may even be cancelled altogether. Thanks to the current rigorous EU-wide monitoring of adverse drug reactions, even rare adverse reactions are quickly detected after a drug has entered the market.
When the benefit-risk ratio of a drug is assessed, considerations like therapeutic indication and the user group are weighted in the conclusions. Understandably, more severe adverse reactions are accepted if a drug is used to treat severe diseases such as cancer, as opposed to a drug that is used to relieve headaches, for example. The marketing authorisation of any drug requires constant assessments of the benefit-risk ratio based on reports on adverse reactions. That is why every report on adverse drug reactions is important for the evaluation of the safety and efficacy of a drug.
The more information the report provides on the user, the drug, the user’s other medication and illnesses and the adverse reaction, the more detailed the analysis can be of the adverse reaction, and that leads to better understanding of the drug’s safety profile for different user groups