E-DRUG: celecoxib warning in Turkey
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Turkish Ministry of Health recently (5 November 2004) took some measures for CELEBREX. According to Turkish Ministry of health, Celecoxib preparations (currently only Celebrex is available in Turkey) must emphasize:
In package inserts:
"For patients whom a COX-2 inhibitor will be prescribed, the risk factors for thrombotic vascular disease should be assessed, such that: COX-2 inhibitors should not be used on patients with active thrombosis (i.e. angina pectoris, myocardial infarction, history of coronary by-pass surgery within the last year, stroke, transient ischemic attack, uncontrolled hypertension, congestive heart failure accompanied by thrombosis).
If they are to be prescribed for patients who currently do not have thrombosis, but have genetic or acquired risk factors for thrombosis, it is recommended that they should be used together with a protective dose of anti-aggregant therapy, with the gastro-intestinal side effects in mind (i.e. low dose acetyl salicylic acid), and/or the patient should be observed very closely for thrombotic vasculopathies.
When a COX-2 inhibitor is prescribed for patients without any risk factors for thrombosis, the patient should be warned about the possible vascular side effects.
In outer box:The below statement/warning should be clearly displayed on the outer box:
"Should not be used on patients with an obstructive vascular disease of the cardiovascular, the brain or other systems"
We hope that this strong warning and black box could be a example for other states.
regards
F. Cankat Tulunay
Turkey
tulunay@dialup.ankara.edu.tr