Statement
FEDRA is the Spanish Pharmacovigilance System of Human Medicines
(SEFV-H) database and is managed by the Spanish Medicines and Health
Products Agency (AEMPS). The information comes from a variety of
sources, and the probability that the suspected adverse effect is
drug-related is not the same in all cases. The discussion and
conclusions of this study are the authors’ responsibility and do not
represent the opinion of the SEFV-H or the AEMPS.