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Tumos w obsvd in th uinay bladd mal ats in th two-ya cacinognicity study [s Nonclinical Toxicology ]. In addition, duing th th ya POactiv clinical tial, 14 patints out 2605 (0.54%) andomizd tACTOS and 5 out 2633 (0.19%) andomizd tplacbw diagnosd with bladd canc. At xcluding patints in whom xposu tstudy dug was lss than on ya at th tim diagnosis bladd canc, th w 6 (0.23%) cass on ACTOS and tw(0.08%) cass on placbo. At compltion th tial, a lag subst patints was obsvd up t10 additional yas, with littl additional xposu tACTOS. Duing th 13 yas both POactiv and obsvational ollow-up, th occunc bladd canc did not di btwn patints andomizd tACTOS placb(H =1.00; [95% CI: 0.59-1.72]).
Actos may alsincas th isk pgnancy in som pmnopausal womn unlss adquat contacption is usd.
Tabl 22. Glycmic Paamts in a 16-Wk Placbo-Contolld, Add-on tMtomin Tial.
This is not a complt list possibl sid cts. I you notic oth cts not listd abov, contact you doctphamacist.
ACTOS xts its antihypglycmic ct only in th psnc ndognous insulin. ACTOS should not b usd ttat typ 1 diabts diabtic ktoacidosis, as it would not b ctiv in ths sttings.
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