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Drug Saf e t y and Availabilit y Drug Alerts and Statements Impo rtingPrescriptio n Drugs Medicatio n Guides Drug Safety Co mmunicatio ns Drug Sho rtages Po stmarket Drug Safety Info rmatio n fo r Patients and Pro viders Info rmatio n by Drug Class Medicatio n Erro rs FDA Drug Safety Newsletter Drug Safety Po dcasts Safe Use Initiative Drug Recalls Drug Integrity and Supply Chain Security
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FDA Drug Saf ety Communication: Update to ongoing saf ety review of Actos(pioglitazone) and increased risk of bladder cancer
Saf e t y Anno unce m e nt Addit io nal Inf o rm at io n f o r Pat ie nt s Addit io nal Inf o rm at io n f o r He alt hcare Pro f e ssio nals Dat a Sum m ary Re f e re nce s Saf e t y Anno unce m e nt [6 -15 -20 11] The U.S. Fo o d and Drug Administratio n (FDA) is info rming the public that use o f the diabetes medicatio n Acto s (pio glitazone) fo r mo re than o ne year may be asso ciated with an increased risk o f bladder cancer. Info rmatio n abo ut this risk will be added to the Warnings and Precautions sectio n o f the label fo r pio glitazo ne-co ntaining medicines. The patient Medicatio n Guide fo r these medicines will also be revised to include info rmatio n o n the risk o f bladder cancer. This safety info rmatio n is based on FDA's review o f data fro m a planned five-year interim analysis o f an o ngo ing, ten-year epidemio lo gical study1 , described in FDA's September 20 10 o ngo ing safety review and in the Data Summary belo w. The five-year results sho wed that altho ugh there was no o verall increased risk o f bladder cancer with pio glitazo ne use, an increased risk o f bladder cancer was no ted amo ngpatients with the lo ngest expo sure to pio glitazo ne, and in tho se expo sed to the highest cumulative do se o f pio glitazo ne. FDA is also aware o f a recent epidemio lo gical study co nducted in France which suggests an increased

Fact s about pioglit azone
So ld as a single-ingredient pro duct under the brand-name Acto s. Also so ld in co mbinatio n with metfo rmin (Acto plus Met, Acto plus MetXR) and glimepiride (Duetact). Used alo ng with diet and exercise to impro ve co ntro l o f blo o d sugar in adults with type 2 diabetes mellitus. Fro m January 20 10 thro ugh Octo ber 20 10 , appro ximately 2.3 millio n patients filled a prescriptio n fo r a pio glitazo ne-co ntaining pro duct fro m o utpatient retail pharmacies.2
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pro duct fro m o utpatient retail pharmacies.2risk o f bladder cancer with pio glitazo ne. Based o n the results o f this study, France has suspended the use o f pio glitazo ne and Germany has reco mmended no t to start pio glitazo ne in new patients. FDA reco mmends that healthcare pro fessio nals sho uld: No t use pio glitazo ne in patients with active bladder cancer. Use pio glitazo ne with cautio n in patients with a prio r histo ry o fbladder cancer. The benefits o f blo o d sugar co ntro l with pio glitazo ne sho uld be weighed against the unkno wn risks fo r cancer recurrence. FDA will co ntinue to evaluate data fro m the o ngo ing ten-year epidemio lo gical study. The Agency will also co nduct a co mprehensive review o f the results fro m the French study. FDA will update the public when mo re info rmatio n beco mes available.Addit io nal Inf o rm at io n f o r Pat ie nt s There may be an increased chance o f having bladder cancer when yo u take pio glitazo ne. Yo u sho uld no t take pio glitazo ne if yo u are receiving treatment fo r bladder cancer. Tell yo ur do cto r right away if yo u have any o f the fo llo wing sympto ms o f bladder cancer: blo o d o r red co lo r in urine; urgent need to urinate o r pain...