Unless there are significant major side-effect such as "death", the F.D.A. will not make any major changes. Side-effects are not just reported by patients, but you can urge your doctors to report any drug adverse effects. FDA does follow up on any severe major side-effect such as death (i.e. any brand of birth control pill causes pulmonary emboli, thromboembolic events such as blood clots resulted in death. I believe Health Canada follows very closely with the recommendation NOT just from the FDA but the Canadian-based American pharmaeutical companies which market birth control pills in Canada. In many cases, it is the "Pharmaceutical Company" that sends in additional "WARNING LABEL" to the FDA, Health Canada and U.K. National Health Service for any additional major side-effects. WARNING : FEW DOCTORS IN AMERICA WILL EVER STAND UP AGAINST ANY PHARMACEUTICAL COMPANY. ONE OF THE BEST DOCTOR IN AMERICA AND IN THE HISTORY OF MEDICINE WAS FIRED FROM HIS JOB FOR STANDING UP FOR PATIENTS' RIGHT. Dr. Eric Topol, M.D., Chief Academic Officer, Provost, of Cleveland Clinic Medical School and Chairman of Cardiology Department was "fired" or his job was eliminated in Feb, 2006 after a few days testifying against Merck about the adverse side-effect of Vioxx, an arthritis medication. Dr. Eric Topol left Cleveland Clinic, the No.1 best Cardiology Program in America after he spent 15 years there. He became a Professor of Genetics at Case Western Reserve University. However, Case Western Reserve University has limited his activity to basic research and "no patient contacts". Or may be don't count on telling "your doctor" any significant side-effects of birth control pills. All the doctors are scare after the "FIRING OF DR. ERIC TOPOL" at Cleveland Clinic for reporting adverse drug effect of Vioxx.