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Warning Label For Products
Containing NSAID and COX-2 Inhibitors
At its 114th
meeting held on 27th April 2000, the DCA reviewed the existing
warning on the gastro–intestinal toxicity of NSAID which was required to
be stated on all NSAID-containing products.
The new warning that was
approved is as follows :-
RISK OF GI
ULCERATION, BLEEDING AND PERFORATION WITH NSAID
Serious GI toxicity
such as bleeding, ulceration and perforation can occur at any time, with
or without warning symptoms, in patients treated with NSAID therapy.
Although minor upper GI problems (e.g. dyspepsia) are common, usually
developing early in therapy, prescribers should remain alert for
ulceration and bleeding in patients treated with NSAIDs even in the
absence of previous GI tract symptoms.
Studies to date have
not identified any subset of patients not at risk of developing peptic
ulceration and bleeding. Patients with prior history of serious adverse
events and other risk factors associated with peptic ulcer disease (e.g.
alcoholism, smoking and corticosteroid therapy) are at increased risk.
Elderly or debilitated patients seem to tolerate ulceration or bleeding
less than other individuals and account for most spontaneous reports for
fatal GI events.
This warning must be
included in the package insert of the product.
Product registration holders
are required to replace the previous warning with the new one as soon as
existing stocks have been used up.
A copy of the package insert
with the new warning should be submitted to the DCA Secretariat for
updating the product dossier. |
