FDA action on Actos
A prescription drug called pioglitazone has over the years proved useful in improving blood glucose
control in adults with Type 2 diabetes. It also has shown success in
preventing prediabetes from turning into Type 2 diabetes. In the
United States, pioglitazone is sold
under the brand name Actos (it
goes by other names in other countries). Its proven effectiveness has
made it one of the top-selling drugs
in the country.
Alas, as with other beneficial
medicines, Actos seems to have
come up against the gremlin of
side effects. Researchers in France
recently released the results of a
very large four-year study that concluded that Actos users had a
higher risk of developing bladder
cancer. The risk was not huge, and
it affected mostly people who used
the drug for a long time or in high
doses, or both. Nevertheless, the
findings prompted officials in
France and Germany to announce
that they were halting the sale of
pioglitazone. The results of the
French study were similar to those
published by California-based
Kaiser Permanente, which also
found a slight increase in bladder
cancer risk among Actos users.
The US Food and Drug Administration (FDA) has also reviewed
the research on Actos. The agency
decided not to go as far as the
Europeans and ban the sale of the
drug, but it did release a statement
saying that use of Actos for more
than one year might be associated
with an increased risk of bladder
cancer. As a result, the FDA said
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that information about the risk
would be added to the “Warnings
and Precautions” section of the
drug’s label. Many physicians,
aware of the medicine’s value, are
reluctant to discontinue its use in
patients who are benefiting from it,
but the consensus appears to be
that at this point it should not be
given to people who have had blad-
der cancer or who have a family his-
tory of the disease. People taking
Actos should also alert their doctor
if they have blood in the urine,
painful urination, or unexplained
abdominal pains. Any further
warnings or actions will depend on
the results of an ongoing 10-year
study of the association between
Actos and bladder cancer. The
results of this study are expected to
be published at the end of 2012.
Heart failure:
What works?
Compared to the general popula-
tion, people with diabetes are at
much greater risk for heart failure,
which is defined as the inability of a
damaged heart to maintain an ade-
quate blood flow. Symptoms
include shortness of breath, tired-
ness, and the buildup of fluid in
the lungs, which leaves people
gasping for air. One study found
that on average, 12 of every 100
elderly persons with diabetes will
be newly diagnosed with heart fail-
ure each year, and 6 of those 12 will
die before the end of the year. So
it’s no surprise that a lot of people
with diabetes are interested in
keeping up with the latest heart
failure research. Some new find-
ings about the effectiveness of cer-
tain drugs and mechanical treat-
ment devices in heart failure
should get their attention.
