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On June 15, 2011, the Food and Drug Administration issued a Drug Safety Communication 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, and that information about this risk would be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines would also be revised to include information on the risk of bladder cancer.

This safety information is based on the FDA’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study, described in the FDA’s September 2010 ongoing safety review and in the Data Summary in the complete Drug Safety Communication. 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.

The FDA is also aware of a recent epidemiological study conducted in France 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.

Food and Drug Administration

Takeda May Face 10,000 U.S. Suits Over Actos Cancer Claim, Jef Feeley, Bloomberg News, Dec 1, 2011

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, 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. Takeda shares fell 2.2 percent at the 3 p.m. close of trading in Tokyo.

The evidence linking Actos to bladder cancer “is unusually strong and clear,” Paul J. Pennock, a New York-based lawyer representing former users of the drug, said in a telephone interview. He said his firm, Weitz & Luxemberg, represents 1,200 former Actos users and that total cases may reach 10,000.

“We are getting calls every day about Actos,” he said.

Pennock was set to appear today before a judicial panel in Savannah, Georgia, to argue that federal court suits over the drug, whose chemical name is pioglitazone, should be gathered for pretrial proceedings in Louisiana or Ohio.

Takeda officials this year pulled Actos, its top-selling drug, off the market in Germany and France after it was linked to an increased cancer risk. The medication had sales of 387.9 billion yen ($4.8 billion) in the last fiscal year, 27 percent of the Osaka, Japan-based company’s revenue.

The drugmaker declined to comment on the impact of the lawsuits to its earnings or whether it plans to set aside money for the litigation.

Company Statement“Takeda already revised the information on risks regarding bladder cancer on leaflets in the U.S. and Japan and is in the process of updating in Europe,” Mitsuo Oguri, a Takeda spokesman in Tokyo, said yesterday by telephone. “Takeda remains confident on the efficacy of pioglitazone for treating type 2 diabetes, while it continues to monitor the safety profile of the medicine.”

The company’s lawyers said in a September court filing that so far it had been sued 54 times over Actos in federal courts around the U.S.

Terrence Allen, a warehouse worker, filed one of them, against Takeda and Eli Lilly & Co. (LLY), which marketed Actos in the U.S. from July 1999 to March 2006. He took the drug over a five-year-period starting in 2006. He was diagnosed with bladder cancer in January.

Stefanie Prodouz, a spokeswoman for Indianapolis, Indiana-based Lilly, didn’t return calls for comment on the Actos suits naming the drugmaker as a defendant.

Cancer Operations

Allen, of Attica, New York, said he’s had two surgeries to remove cancerous tissue from his bladder and may be facing another after the Christmas holiday.

“If somebody had told me I could get cancer from Actos, I never would have taken it,” he said in a telephone interview.“There were other products out there that could have helped treat my diabetes without putting me through all of this.”

Allen, 57, said he sued the drugmaker to help alert other diabetics that Actos poses serious health risks. He’s also hoping the litigation will force Takeda to take responsibility for his injuries, he said.

“To some degree, I would like my pound of flesh from the company,” he said.

Plaintiffs’ lawyers say they expect thousands more former Actos users to join Allen in suing Takeda over the drug given its rise in popularity after GlaxoSmithKline Plc (GSK)’s Avandia diabetes drug was found to pose an increased heart-attack risk.

Glaxo officials pulled the drug from European markets and curtailed sales in the U.S. in 2007 after studies found Avandia posed greater risk of heart attacks and strokes than Actos.

$6 BillionThe London-based drugmaker has paid more than $6 billion for legal costs tied to Avandia and other medicines. In the wake of Avandia’s problems, Actos’s sales rose from about $3 billion in 2006 to almost $5 billion last year.

Will Kemp, a Las Vegas-based attorney representing former Actos users, said the suits will differ from Avandia cases because the alleged injuries are more distinctive.

“Bladder cancer is considered to be a signature injury because there aren’t a lot of other things that cause that particular illness,” he said. “With a heart attack or stroke, you’d have a slew of other potential causes to deal with.”

Turner Branch, a New Mexico-based plaintiffs’ lawyer, said Takeda also will face claims that Actos caused heart attacks and strokes like Avandia. “I think this is going to be very large litigation with a large number of cases,” he added.

Before corralling the litigation in one court, judges on the so-called Multi-District Litigation panel will hear arguments today on which federal court should be selected.

Pretrial StepsSimilar cases in courts across the U.S. can be consolidated before one judge for pretrial exchange of information. The consolidation is intended to save money by streamlining document exchanges and avoiding duplication.

Lawyers for Takeda and some of the plaintiffs are arguing in court papers that the Actos suits should be consolidated in federal court before U.S. District Judge James Zagel in Chicagoor before U.S. District Judge Rebecca Doherty in Lafayette,Louisiana.

Other plaintiffs’ attorneys are suggesting the cases be collected before U.S. District Judge Daniel Polster inCleveland, according to court filings. Another group of lawyers seek to have the suits consolidated in federal court in Birmingham, Alabama.

Allen’s case is Terrence Allen v. Takeda Pharmaceuticals North America Inc., 11-cv-643, U.S. District Court for the Western District of New York (Buffalo).