تم نقله للأهمية القصوى
Celebrex دواء إسمه
كل واحد يشيك على أدويته وأدوية أهله خصوصا اللي يتعالجون في عيادة المسالك البوليه والروماتيزم والاعصاب والعظام
إكتشفوا خطورته الشديده على الحياه بعد ما سبب نزيف بالدماغ لعدة أشخاص وجاء تعميم فوري بتبليغ المرضى في البيوت لوقف إستخدامه حالا .!!!
هذا الدواء احد آثاره الجانبية الفشل الكلوي التام هذا الدواء وأشكاله من مسكنات الآلام الحديثة الإنتاج والتي لم يجرى عليها دراسات تأكيدية ومكثفة وللعلم هذا الدواء له فقط اقل من ست أو سبع سنوات من إنتاجه وتجاربه وإطلاقه للأسواق , اعتقد انه أطلق للأسواق في الدول النامية فقط كي يعرفوا نتائج آثاره الجانبية يعني صرنا حقول تجارب لشركات الأدوية الأوروبية والأمريكية فالمعروف هناك في أوروبا وأمريكا خاصة أن الأدوية وخاصة المضادات الحيوية والمسكنات القوية لا تصرف إلا تحت رقابة شديدة من قبل وزارات الصحة والإشراف الشديد على حالات العلاج الخاصة التي تحتاج لمثل هذه الأدوية
As received…..
Girish.
Gentlemen
Please do not ignore this message. It is true. I went myself today to the Aramco clinic and I found this message is correct. For your information, this is not the only medicine that found to increase risk of CARDIOVASCULAR. Another medicine which I used to take since long time (Naproxen) was also found to increase the risk of cardiovascular.
Best regards
Be careful
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
FDA Statement
FOR IMMEDIATE RELEASE
Statement
December 17, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex
The FDA today released the following statement on the halting of a clinical trial of the Cox-2 inhibitor Celebrex (celecoxib):
The Food and Drug Administration (FDA) learned last night from the National Cancer Institute (NCI) and Pfizer, Inc., that NCI has stopped drug administration in an ongoing clinical trial investigating a new use of Celebrex (celecoxib) to prevent colon polyps because of an increased risk of cardiovascular (CV) events in patients taking Celebrex versus those taking a placebo.
Patients in the clinical trial taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of CV events compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.
A similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.
Although these are important findings, at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action.
While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market.
Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. FDA advises evaluating alternative therapy. At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex.
Patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians.
Celebrex was approved in 1998 for the treatment of osteoarthritis and rheumatoid arthritis. Previous large studies of Celebrex, including clinical trials and epidemiology studies, have not suggested the sort of CV risk found in the NCI polyp study. Because similar long-term studies of other products in the class of non-steroidal anti-inflammatory drugs (NSAIDS), other than
Cox-2 inhibitors have not been done, it is not known whether other NSAIDS pose a similar risk.
FDA will provide updates on Celebrex in particular and this class of drugs in general as more information becomes available.
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