June 15, 2011 (Silver Spring, Maryland) — The FDA has issued an update to its ongoing safety review of pioglitazone (Actos, Takeda), informing physicians and the public that use of the drug for more than 12 months is linked to an increased risk of bladder cancer .
The news comes within days of French regulators announcing that they are suspending sales of the drug; German regulators also announced last week that pioglitazone should not be started in new patients.
In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information.
Specifically, says the FDA, physicians should:
Not use pioglitazone in patients with active bladder cancer.
Use pioglitazone with caution in patients who have a prior history of bladder cancer, adding "the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence."
Tell patients to report any signs or symptoms of "blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer."
Urge patients to read the pioglitazone medication guide.
Report adverse events involving pioglitazone medicines to the FDA MedWatch program.
As previously reported by heartwire , the FDA has been reviewing the safety of pioglitazone since September 2010, citing preliminary epidemiological evidence that suggests that the diabetes medication may be linked to a higher risk of bladder cancer. Just last week, an FDA spokesperson predicted that the agency's review would "be complete within the next couple of months." Of note, the FDA announcement today refers to the review as "ongoing."
The FDA's announcement today includes an update on the data used to make the recommendations and notes that the FDA was "aware" of the French analysis that led to the action taken in that country.
The FDA review is based on an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193 000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan. The FDA today specified that compared with never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk in the KPNC analysis and that after more than 24 months of pioglitazone use that increased risk remained, although the statistical significance of the finding was weaker. "Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100 000 person-years follow-up, compared with never use of pioglitazone," today's notice reads.
Additional details on the FDA's data review are included in the announcement.
According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies in the US from January 2010 through October 2010.
Heartwire from Medscape © 2011 Medscape, LLC
Cite this: Pioglitazone for 1 Year May Increase Risk of Bladder Cancer - Medscape - Jun 15, 2011.