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.