On the heels of that hearing there is this report from Bloomberg:
Takeda may face as many as 10,000 lawsuits in U.S. courts over allegations that its Actos diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated.
U.S. regulators found in June that an analysis of a company-sponsored study showed some users of Actos, the world’s best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease.
From the FDA
[6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
Facts about pioglitazone
FDA is also aware of a recent epidemiological study conducted in France2 which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.
FDA recommends 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 benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.
Additional Information for Patients
- There may be an increased chance of having bladder cancer when you take pioglitazone.
- You should not take pioglitazone if you are receiving treatment for bladder cancer.
- Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
- Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
- Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
- Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.