二、下列內文為美國 FDA 於今年六月十五日發布有關 pioglitazone 的安全訊息，請說明遇有民眾詢問時，藥師應如何答覆？並討論我國藥品安全的機制應如何提昇？（20 分）Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of BladderCancerUse of the diabetes medication Actos (pioglitazone) for more than one year may beassociated with an increased risk of bladder cancer. Information about this risk will beadded to the Warnings and Precautions section of the label for pioglitazone-containingmedicines. The Patient Medication Guide for these medicines will also be revised toinclude information on the risk of bladder cancer.This safety information is based on FDA's review of data from a five-year interim analysisof an ongoing, ten-year epidemiological study. The five-year results showed that althoughthere was no overall increased risk of bladder cancer with pioglitazone use, an increasedrisk of bladder cancer was noted among patients with the longest exposure to pioglitazone,and in those exposed to the highest cumulative dose of pioglitazone.FDA is also aware of a recent epidemiological study conducted in France which suggestsan increased risk of bladder cancer with pioglitazone. Based on the results of this study,France has suspended the use of pioglitazone and Germany has recommended not to startpioglitazone in new patients.Additional Information for Patients, Information for Healthcare Professionals, and a DataSummary are provided in the Drug Safety Communication.FDA recommends that healthcare professionals should:․ Not use pioglitazone in patients with active bladder cancer.․ Use pioglitazone with caution in patients with a prior history of bladder cancer. Thebenefits of blood sugar control with pioglitazone should be weighed against theunknown risks for cancer recurrence.FDA will continue to evaluate data from the ongoing ten-year epidemiological study. TheAgency will also conduct a comprehensive review of the results from the French study.FDA will update the public when more information becomes available.