December, 2011 Actos News: Takeda May Face 10,000 U.S. Suits Over Actos Cancer Claims

I just attended the JPML hearing regarding petitions to centralize the Actos litigation. A full court room in the USDCT in Savannah, GA.  Takeda seeks an MDL placement in Illinois, given that it is based in that state. Others seek Louisiana among other states. I'm hearing a decision will be made by year end.

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.

Source: 
http://www.bloomberg.com/news/2011-12-01/takeda-may-face-10-000-u-s-suits-over-actos-cancer-claims.html

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

Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus. From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.2

This safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study¹, described in FDA's September 2010 ongoing safety review¹ and in the Data Summary below. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of 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.

FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.

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.