The adverse effects of this product marketed in France since November 2006 remain similar, “benign and transient”, according to Afssaps. It would be in 85% of the cases of fevers, rashes of urticaria type and vasovagal syncope.
The analysis of serious side effects, which may lead to hospitalization, shows a favorable outcome for the patients.
The health agency estimates that the autoimmune manifestations collected, such as thyroiditis, or insulin-dependent diabetes, remain low and lower than those observed in the general population.
The analysis of the cases would not have resulted in a cause and effect relationship between the use of the drug and the complications observed.
The European Agency for the Evaluation of Medicines (EMEA) had recommended modifying the summary of product characteristics to include the risk of “syncope sometimes accompanied by tonic-clonic movements”.
The health agency reminds in this context that people vaccinated with Gardasil must be followed carefully during the 15 minutes following its administration.
The Afssaps has carried out the follow-up of more than five million adolescent girls and young girls aged 14 to 23, for whom the first analyzes are underway. At the end of 2009, a report indicates that around 2.7 million doses of Gardasil had been distributed, and 1.1 million young girls had been vaccinated.
Gardasil is recommended for 14-year-old adolescents, with a catch-up up to 23 years for those who have not yet had sex or at the latest during the year following this first intercourse. It is marketed by the Sanofi Pasteur MSD laboratory.
Source: Afssaps
