SUBMISSION OF ADVERSE DRUG REACTION REPORTS ON COX-2 INHIBITORS AS PART OF SAFETY MONITORING
National Administrative Register [ BFAD BUREAU CIRCULAR NO. 14, S. 2004, October 12, 2004 ]
The Bureau of Food and Drugs, after careful evaluation on the recent voluntary withdrawal of ROFECOXIB (VIOXX) from the Philippine market by its local company Merck Sharp & Dohme Philippines, has determined that all concerned pharmaceutical establishments with COX-2 inhibitors are required to monitor and submit adverse drug reaction reports on serious cardiovascular events including heart attacks and strokes.
Accordingly, the following COX-2 inhibitors shall be monitored and establishments should submit a monthly adverse drug reactions reports for 3 years:
(1) Celecoxib
(2) Valdecoxib
(3) Meloxicam
(4) Etoricoxib
For strict and immediate compliance.
Adopted: 12 Oct. 2004
(SGD.) PROF. LETICIA BARBARA B. GUTIERREZ, M.Sc.
Director