Gastrointestinal and cardiovascular reactions form the majority of adverse reactions to rofecoxib reported on "yellow cards".
In September's Current problems in pharmacovigilance, the Committee on Safety of Medicines and Medicines Control Agency say that up to July this year, there were 1,120 reports via the "yellow card" scheme of suspected adverse reactions to rofecoxib. GI adverse events accounted for 554 reports, almost half of the total number. Of these, 84 per cent were for nausea, dyspepsia, diarrhoea and abdominal pain, and 12 per cent were for upper GI perforations, ulcerations and bleeds (PUBs). Among PUBs cases, there were five fatal outcomes. The majority of cardiovascular reactions were for oedema (101 of 177 reports). Other adverse cardiovascular effects included hypertension, palpitations, cardiac failure and myocardial infarction. The MCA/CSM reminds prescribers that rofecoxib is contraindicated in patients with active peptic ulceration or GI bleeding and in severe congestive heart failure. Other reported adverse reactions to rofecoxib included depression, confusion, hallucinations, angioedema, bronchospasm, renal failure, abnormal hepatic function and rashes.
The safety profile of celecoxib will be reported in a forthcoming bulletin, the MCA/CSM adds.