# \[e-drug\] celebrex in Turkey **URL:** \ **Category:** e-drug\ **Created:** [November 22, 2004, 9:09am UTC](https://talk.edrugplus.org/t/e-drug-celebrex-in-turkey/21070 "2004-11-22T09:09:51Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![F.CANKAT\_TULUNAY](https://avatars.discourse-cdn.com/v4/letter/f/65b543/32.png) [@F.CANKAT\_TULUNAY](https://talk.edrugplus.org/u/F.CANKAT_TULUNAY)\ **Post date:** [November 22, 2004, 9:09am UTC](https://talk.edrugplus.org/t/e-drug-celebrex-in-turkey/21070/1 "2004-11-22T09:09:51Z")
E-DRUG: celebrex in Turkey ---------------------------- 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