HOW SAFE ARE THE SAFEST IBD DRUGS?
2003 • Volume 124 • Number 7
Ransford RAJ, Langman MJS (Queen Elizabeth Hospital, Birmingham, UK). Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut 2002;51:536-539.
(sulphasalazine) and mesalamine (mesalazine) each deliver 5-aminosalicylic
to the colon. These topical anti-inflammatory
compounds have become standard therapy for inflammatory bowel disease,
particularly ulcerative colitis. Sulfasalazine has a 5-ASA molecule bound
to sulfapyridine. Because sulfapyridine contributes to toxicity in selected
patients but does not have activity against colonic inflammation, several
new systems were designed to deliver 5-ASA to the bowel without sulfapyridine.
Today, these mesalamine compounds are prescribed more commonly than sulfasalazine
in many parts of the world (Gut 2002;51:548-549). Their popularity
is largely based on perceived better tolerance rather than documented
improved efficacy, particularly for ulcerative colitis (BMJ 1989;298:82-86,
Ann Intern Med 1993;118:540-549). Recently, concern has been raised
about the safety of mesalamine, particularly with regards to renal toxicity
and pancreatitis. In contrast, sulfasalazine has been implicated as causing
blood dyscrasias. Because of the rarity of these events, proof of the
proposed associations has been difficult. To attempt to answer these
questions, Ransford and Langman analyzed data from spontaneous reports
to the Committee on Safety of Medicines (CSM) in the United Kingdom (Gut