Stevens–Johnson syndrome and toxic epidermal necrolysis: The Food and Drug Administration adverse event reporting system, 2004–2013

[Dear Editor] Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which are severe cutaneous adverse reactions, are associated with fatal disorders. Although many causes of SJS/TEN have been proposed, their pathogenesis is not fully understood. Hypersensitivity to medications accounts for the majority of cases of SJS/TEN. Several research groups have presented reports on drugs implicated in SJS/TEN (selective cyclooxygenase-2 inhibitors, lamotrigine, anti-epileptic drugs, sulfonamide antibiotics, and allopurinol, etc.). SJS associated with Mycoplasma pneumoniae infection is observed mainly in children, while another group reported the effects of the genetic background of patients. The relationship between aging and SJS/TEN is still not clear. Since SJS/TEN are very rare diseases, the implementation phase of epidemiologic research is fraught with difficulties. The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is the largest and most well-known database worldwide, and it reflects the realities of clinical practice. FAERS, therefore, is one of the primary tools used in pharmacovigilance.