Afssaps has published on 15 March 2011 a list of 77 medicinal products under reinforced surveillance. All the medicinal products on the list have national our European Marketing Authorizations: the benefit they provide to patients, when used according to their therapeutic indication, is considered much more important than the risk associated with their use.
All medicinal products are screened for undesirable effects once they are commercialized (pharmacovigilance). Additionally, some medicinal products are the subject of a reinforced surveillance:
– if they have a new active substance or belong to a new pharmacological class ;
– when new pharmacovigilance signs are detected on a medicinal product which is already on the market and therefore detailed analysis and adapted measures are necessary.
Nevertheless, the presence of a medicinal product on that list must not lead patients to interrupt their treatments without speaking with their doctor or pharmacist.
Source : Afssaps.