THURSDAY, June 16 (HealthDay News) -- The U.S. Food and Drug
Administration is warning consumers that the popular diabetes drug
Actos (pioglitazone) may increase the risk of bladder cancer when
used for more than a year.
The agency's warning comes five days after Germany and France
pulled Actos from the market, citing similar concerns. Actos is in
a class of drugs called thiazolidinediones, the only other member
of which, Avandia (rosiglitazone), was taken off U.S. pharmacy
shelves in May because it was linked to an increased risk of heart
The new cancer warning will appear on the labeling, the FDA
However, although Actos does have some side effects, "the
beneficial effects of Actos, I think, outweigh any possible risk of
cancer," said Dr. Joseph Giangola, medical director of diabetes at
Hackensack University Medical Center in Hackensack, N.J.
Actos is used to control blood sugar and is sold alone or in
combination with metformin (Actoplus Met, Actoplus Met XR) and
glimepiride (Duetact). In 2010, more than 2 million patients were
taking these drugs, according to the FDA.
The new warning is based on FDA's review of data from an ongoing
study, which found that Actos increased the risk of bladder cancer
among patients taking the drug over a long period at the highest
In one study involving more than 193,000 patients with diabetes,
patients taking Actos were on the drug for an average of two years,
the FDA said. "Compared to never being exposed to pioglitazone, a
duration of pioglitazone therapy longer than 12 months was
associated with a 40 percent increase in risk [for bladder
cancer]," the agency said.
In addition, the agency says it is aware of the French study
that caused France to pull the drug. That study showed a
dose-response effect, where risks for bladder cancer rose as time
spent taking Actos lengthened past one year.
Right now, the FDA is advising doctors not to use Actos in
patients with bladder cancer and to use it with caution in patients
who have had bladder cancer. In addition, the agency says that "the
benefits of blood sugar control with pioglitazone should be weighed
against the unknown risks for cancer recurrence."
The agency said diabetes patients should also tell their doctor
if they are having symptoms of bladder cancer such as blood or red
color in urine, an urgent need to urinate or pain while urinating
and pain in back or lower abdomen.
In addition, patients should talk to their doctor about any
concerns they have about Actos, the FDA noted.
For his part, Giangola said he is cautious when prescribing
Actos. "We try to select the most insulin-resistant people to give
Actos to," he said. "Those people do well with Actos."
But if Actos was taken off the market, there would be nothing to
replace it, Giangola said. With Avandia essentially gone, "there is
no medicine that directly influences insulin resistance the way
Actos does," he said.
Giangola added that patients should not be overly concerned
right now. "To jump now when we have only one medication in this
class would be rash," he said. "They really ought to wait until
there is more definitive evidence."
"What's worse -- the theoretical risk [of cancer] or the well-known risk of letting your blood sugar remain high? I say it's clearly [the risk of] letting your blood sugar run higher," Giangola said.
In a statement, Takeda Pharmaceuticals North America Inc., the
maker of Actos, said it remains positive about the drug.
The company said in a statement that it is "confident in the
therapeutic benefits of Actos and its importance as a treatment for
type 2 diabetes. The company remains committed to Actos and
Actos-containing medications, and to the millions of people living
with the disease."
For more information on diabetes, visit the
U.S. National Library of Medicine.