E-DRUG: celebrex in Turkey
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Dear all,
Turkish Pfizer voluntarily withdrew Celebrex from the Turkish Market on November November 19, 2004.
A week ago Turkish Ministry of Health asked from Pfizer new warnings to be added to the package insert form and on the outer package.
regards
Prof. Dr. F. Cankat Tulunay
President of Turkish Clinical Pharmacological Society
tulunay@dialup.ankara.edu.tr
PRESS RELEASE FROM TURKISH MINISTRY OF HEALTH
FROM DIRECTORATE GENERAL OF PHARMACEUTICAL AFFAIRS
MINISTRY OF HEALTH
ANKARA TURKEY
According to the decision of the Human Medicinal Products Advisory
Committee regarding COX-2 inhibitors, which is dated 05.11.2004, new
warnings to be added to the prospectus and on the package of Celebrex 100
mg. and 200 mg capsule (Pfizer) are requested. The concerned warnings are
listed below:
Additional information to be added to the prospectus:
"The risk group of thrombotic vascular diseases should be defined
obviously for the patients who will be treated with COX-2 inhibitors.
This means;
1. Existence of active thrombosis: COX-2 inhibitors should not be used
for the treatment of patients who were diagnosed as having active thrombosis
(angina pectoris, myocardial infarction, coronary by-pass history of last
one year, stroke, transient ischemic attack, uncontrolled hypertension,
congestive heart failure combined with thrombosis)
2. Active thrombosis does not exist, but there is a congenitally or an
acquired thrombosis risk factor: Prophylactic dose of antiaggregant
treatment (low doses of acetyl salicylic acid) should be combined, taking
into account the gastrointestinal adverse effects of the latter. Patients
should be monitories closely for the thrombotic vasculopathies.
3. No risk of thrombosis: Patients should be warned about the vascular
adverse effects of COX-2 inhibitors.
Notification which should be written on the package to be read obviously:
"Should not be used by individuals who have obstructive arterial disorder
of cardio-vascular system, central nervous system or other systems".
Reimbursement conditions:
"COX-2 inhibitors could only be prescribed by orthopedic surgeons,
rheumatologists, specialist in physical therapy, specialist in internal
medicine, cardiologist and neurologist. The indication should be
identified, and the absence of obstructive arterial disorder or high
thromboembolic risk of cardio-vascular system, central nervous system or
other systems should be verified by a medical committee. This committee
should include either a cardiologist or a neurologist