Nausea, dizziness, fatigue… The time it takes for the adverse effects of a drug to appear varies depending on the molecules. Our advice for knowing when to be alerted and react with Dr Monique Quillard general practitioner.
Whether they occur a few minutes after taking or years later, the side effects of a medication should never be taken lightly. While some are harmless, others can have a serious impact on your health or require an immediate review of your treatment. But how can you tell the difference between a classic side effect and a serious adverse effect? What is the real role of the notice and how to react effectively in case of doubt? Insights with Dr Monique Quillard, general practitioner.
A side effect is an effect caused by a medication which is not initially sought in its prescription. “Side effects are not necessarily harmful and are generally known for molecules that have been studied for a long time and have been on the market for a long time. They are notified on the medication leaflet. They can occur following “normal” treatment or overdose, misuse, etc.” explains Dr Monique Quillard, general practitioner.
“Adverse effects can occur very quickly, 24 to 48 hours after the first dose, or occur after several months or years and even a long time after stopping the drug, for example Mediator which caused damage to the heart valves and numerous deaths. The same goes for Distilbene which was responsible for malformations and sterility in women“, answers Dr. Quillard.
Yes, laboratories must report the effects of which they are aware on the treatment leaflet or on the European Eudravigilance database. “They include in the leaflet the adverse effects that appeared during clinical trials, then those which were reported to the pharmacovigilance centers and documented.“, specifies our expert. Note that digital notices are now updated in real time on official health sites.
If this is bothersome or serious, you should notify the doctor who prescribed the responsible treatment, in order to discuss with him whether it is necessary to stop or replace it. Then, it is important to report this effect to the regional pharmacovigilance center so that it is recorded. “Health professionals or users can report any adverse event to the health authorities in just a few clicks on the signalement-sante.gouv.fr website, including adverse effects, incidents or risks of incidents linked to health products.advises Dr. Quillard.
A side effect is not necessarily “undesirable”. Health authorities favor the term “adverse reaction” for any negative reaction linked to the intended or improper use (overdose, medical error) of a product. The authorities also speak:
→ serious adverse reaction to designate an adverse reaction that is fatal or likely to be life-threatening, or results in significant or lasting disability or incapacity, or causes or prolongs hospitalization, or manifests itself as an abnormality or congenital malformation.
→ unexpected adverse effect to designate an adverse effect whose nature, severity or course do not correspond to the regulatory information for the medicinal product.
The patient, or his representative (in the case of a child for example), as well as doctors and any other healthcare professional (nurse, physiotherapist, etc.) can report the effect experienced to the regional pharmacovigilance center (CRPV). The report is analyzed by experts, then recorded in the national pharmacovigilance database in an anonymized manner. This civic approach is essential: it has made it possible, in recent years, to better regulate the use of certain common vasoconstrictors or anti-inflammatories.
Thanks to Dr Monique Quillard general practitioner.
