This update provides a follow-up to the Drug
Safety Communication: Update to ongoing safety review of Actos (pioglitazone)
and increased risk of bladder cancer1 issued on 6/15/2011.
[8-4-2011]
The U.S. Food and Drug Administration (FDA) is informing the public that the
Agency has approved updated drug labels for the pioglitazone-containing
medicines to include safety information that the use of pioglitazone for more
than one year may be associated with an increased risk of bladder cancer. FDA
previously communicated these labeling changes to the public on June 15, 2011
(Drug Safety Communication)2.
The
updated drug labels recommend 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.
The
updated drug labels recommend that patients should:
*
Contact their healthcare professional if they experience any sign of blood in
the urine or a red color in the urine or other symptoms such as new or
worsening urinary urgency or pain on urination since starting pioglitazone, as
these may be due to bladder cancer.
Healthcare
professionals and patients can access the latest drug labels for
pioglitazone-containing medicines at:
·Actos (pioglitazone)3
·Actoplus Met (pioglitazone/metformin)4
·Actoplus Met XR (pioglitazone/metformin
extended-release)5