Additional safety information issued for infliximab
Additional safety information for the tumour necrosis factor inhibitor infliximab (Remicade) has been released by the drug's manufacturer.
In a “Dear health care professional” letter dated 7 June,
Schering-Plough and Centocor warn that, since infliximab’s launch
in 1998, six cases of hepatosplenic T-cell lymphoma have been reported
in patients with Crohn’s disease treated with infliximab.
Five of these cases were in patients aged 12 to 19 years; all patients
were taking concomitant azathioprine or 6-mercaptopurine. Exposure to
infliximab ranged from one infusion to approximately four years of maintenance
therapy.
Hepatosplenic T-cell lymphoma is rare and follows an aggressive course,
which is usually fatal. The manufacturers say that, although a risk for
the development of hepatosplenic T-cell lymphoma in patients treated
with infliximab cannot be excluded, the risk benefit ratio remains positive
for the approved
indications.
It is estimated that approximately 270,000 patients worldwide with Crohn’s
disease have been exposed to infliximab, 10,000 of these being below
18 years old. In the EU the use of infliximab in patients under 18 years
is off-label and its magnitude is unknown.
The cases were identified as part of a US Food and Drug Administration
review of infliximab following a licence application for its use in Crohn’s
disease patients between six and 17 years. The licence was granted in
May.
The manufacturers urge health care professionals to report any suspected
cases of hepatosplenic T-cell lymphoma. The summary of product characteristics
for Remicade will be updated in due course. |
The
Pharmaceutical Journal
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