Pharmaceutical Drug Litigation Updates

Judge sets 1st hearing for diabetes drug lawsuits

Quoted from http://finance.yahoo.com/news/Judge-sets-1st-hearing-apf-2924697166.html

Judge sets 1st hearing for diabetes drug lawsuits

Judge to hold hearing for batch of suits linking Takeda diabetes drug to bladder cancer risks

By Michael Kunzelman, Associated Press | Associated Press

February 14, 2012

NEW ORLEANS (AP) -- A federal judge in Louisiana has scheduled an initial court hearing for a batch of lawsuits that claim Takeda Pharmaceuticals' top-selling diabetes drug, Actos, carries an increased risk of bladder cancer.

In an order issued Monday, U.S. District Judge Rebecca Doherty said she plans to appoint lead attorneys for the consolidated cases after the March 22 status conference in her Lafayette, La., courtroom.

In December, the U.S. Judicial Panel on Multidistrict Litigation assigned Doherty to preside over dozens of lawsuits against Actos maker Takeda Pharmaceuticals America Inc., which is based in Deerfield, Ill. Plaintiffs' attorneys expect to file several thousand claims against Takeda and its related companies on behalf of people who used the drug.

[Article continues at original source]

Takeda Actos Cancer Suits Combined in Louisiana Court, U.S. Panel Rules

Quoted from http://www.bloomberg.com/news/2011-12-31/takeda-suits-on-actos-diabetes-drug-combined-in-one-louisiana-court.html

Takeda Actos Cancer Suits Combined in Louisiana Court, U.S. Panel Rules

By Margaret Cronin Fisk and Jef Feeley - Dec 30, 2011 7:54 PM ET

Lawsuits against Takeda Pharmaceutical Co., Asia’s biggest drugmaker, claiming its Actos diabetes drug causes bladder cancer will be consolidated before one judge in federal court in Louisiana, a judicial panel said.

The federal Judicial Panel on Multidistrict Litigation sent the lawsuits to the Western District of Louisiana, in Lafayette, to be overseen by U.S. District Judge Rebecca Doherty. Doherty will coordinate pretrial proceedings, including evidence- gathering.

“Centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the panel ruled yesterday. It will also allow “the panel to assign the litigation to an experienced judge who sits in a district in which no other multidistrict litigation is pending.”

The lawsuits claim that patients who use Actos, a prescription drug approved for the use in treating type 2 diabetes, increases the risk of bladder cancer. The plaintiffs also claim that Takeda and co-defendant Indianapolis-based Eli Lilly & Co. (LLY) withheld information about the risk and failed to provide adequate warnings.

[rticle continues at original source]

Diabetes drug class action launches

Quoted from http://www.cbc.ca/news/health/story/2011/12/22/daibetes-actos-class-action.html

Diabetes drug class action launches

Suit alleges manufacturer should have disclosed increased bladder cancer risk

CBC News

Posted: Dec 22, 2011 11:44 AM ET

DOCUMENT | FDA - Actos (pioglitazone): Ongoing Safety Review

A class action has been launched on behalf of people who took the diabetes drug Actos against the manufacturers of the medication.

The class action alleges that Takeda Pharmaceutical Company, the manufacturer and distributor of Actos (pioglitazone hydrochloride) and Eli Lilly, who used to sell and distribute the drug, failed to disclose that taking it for longer than one year led to an increased risk of bladder cancer.

The suit has been filed with the Ontario Superior Court of Justice.

The lead plaintiff in the class action is a now-deceased Toronto woman who was prescribed Actos in 2002. She died in April after battling bladder cancer for over two years.

[Article continues at original source]

Takeda May Face 10,000 U.S. Suits Over Actos Cancer Claims

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

Takeda May Face 10,000 U.S. Suits Over Actos Cancer Claims

December 01, 2011, 6:08 AM EST

By Jef Feeley

 

Dec. 1 (Bloomberg) -- Takeda Pharmaceutical Co., 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.

[Article continues at original source]

Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

Quoted from http://www.bloomberg.com/news/2011-06-24/takeda-s-actos-glaxo-s-avandia-raise-risk-of-eye-disease.html

Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

By Elizabeth Lopatto - Jun 24, 2011 5:00 PM ET

Takeda Pharmaceutical Co.’s Actos, the world’s best-selling diabetes treatment, and GlaxoSmithKline Plc. (GSK)’s Avandia raise the risk of an eye disease that can lead to blindness, a study shows.

People taking the drugs have a 3 to 6 times increased risk of developing diabetic macular edema, a condition in which the retina thickens and swells, according to a study of more than 100,000 people to be presented Sunday at the American Diabetes Association’s annual meeting in San Diego.

Diabetic eye disease is the most common cause of blindness in working-age Americans, according to the National Eye Institute. Macular edema damages the retina and can eventually cause blindness. The best way to prevent the side-effect of diabetes is to keep blood sugar under control, according to the National Eye Institute.

“Patients at high risk of sight-threatening DME should avoid” the class of drugs including Actos and Avandia, the study authors, led by Richard Donnelly at the University of Nottingham, wrote in their study abstract. High-risk patients include those who have poor control of their blood sugar and those with a previous history of macular edema.

[Article continues at original source]

EU delays verdict on Takeda diabetes drug to July

Quoted from http://www.reuters.com/article/2011/06/23/takeda-idUSL3E7HN2J820110623

EU delays verdict on Takeda diabetes drug to July

Thu Jun 23, 2011 12:08pm EDT

 

LONDON, June 23 (Reuters) - European regulators on Thursday put back a decision until July on whether Takeda Pharmaceutical's diabetes drug Actos should remain on the market or not due to a possible link to bladder cancer.

The European Medicines Agency (EMA), which had been due to deliver a verdict this week, said there were "still numerous issues that needed to be resolved" before it could make a recommendation on the drug's future use.

It will finalise its recommendation at the next monthly meeting of its experts in July.

[Article continues at original source]

Takeda’s Diabetes Drug Tied to Cancer Risk, U.S. FDA Says

Quoted from http://www.businessweek.com/news/2011-06-16/takeda-s-diabetes-drug-tied-to-cancer-risk-u-s-fda-says.html

Takeda’s Diabetes Drug Tied to Cancer Risk, U.S. FDA Says

June 16, 2011, 2:41 AM EDT

By Molly Peterson

June 16 (Bloomberg) -- Takeda Pharmaceutical Co.’s diabetes drug Actos may raise bladder cancer risks in patients who take the medicine for more than a year, U.S. regulators said.

A five-year interim analysis of data from a decade-long company-sponsored study showed a greater likelihood of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses, the Food and Drug Administration said in a safety announcement yesterday. The medicine from Osaka, Japan-based Takeda, Asia’s biggest drugmaker, wasn’t linked to an overall increased cancer risk in all patients who took it.

Actos, the world’s biggest-selling diabetes drug, had shown a potential risk of bladder cancer in earlier studies on rats and humans. Takeda won FDA approval of the treatment in 1999 and agreed to conduct the 10-year study to assess that risk. Actos became the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from London-based GlaxoSmithKline Plc’s Avandia.

[Article continues at original source]

Germany joins France in suspending top Takeda drug

Quoted from http://www.reuters.com/article/2011/06/10/takeda-germany-idUSL3E7HA0X920110610

Germany joins France in suspending top Takeda drug

Fri Jun 10, 2011 7:40am EDT

 

By James Topham and Ben Hirschler

TOKYO/LONDON, June 10 (Reuters) - Germany has joined Francein suspending the use of Takeda Pharmaceutical's Actos diabetes drug, due to worries about a possible link to cancer.

The move is a blow for the Japanese firm, whose best-selling drug has worldwide sales of close to $5 billion, though the financial impact will be limited by the fact the drug faces looming generic competition in key markets.

Shares in Takeda fell 2.9 percent on Friday, against a 0.5 percent rise in the benchmark Nikkei average.

On Thursday, France's drug safety authority suspended use of both Actos and Competact -- which combines Actos and an older drug called metformin -- after an official French study found they appeared to slightly raise the risk of bladder cancer.

Germany's Federal Institute for Drugs and Medical Devices (BfArM) said it had decided to follow suit after receiving results of the study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009.

[Article continues at original source]

France suspends Takeda diabetes drugs use

Quoted from http://www.reuters.com/article/2011/06/09/france-pharma-idUSLDE7581P420110609

France suspends Takeda diabetes drugs use

PARIS, June 9 | Thu Jun 9, 2011 10:15am EDT

PARIS, June 9 (Reuters) - France's drug safety authority said on Thursday it had suspended the use of two diabetes treatments from Japan's Takeda Pharmaceutical Co. Ltd. because of concerns about cancer risks.

The AFSSAPS drug authority said it had decided to pull the drugs Actos and Competact because an official study had found they appeared to slightly raise the risk of patients getting cancer of the bladder.

The authority told doctors to stop prescribing the two drugs, but said people who use them should continue to do so until they can consult their doctors.

AFSSAPS said it decided to suspend the drugs after a recent study by the French public health insurance office highlighted the cancer risk of an ingredient called pioglitazone.

Actos was approved for use in Europe in 2000 and Competact in 2006 and some 230,000 people use the drugs in France, according to AFSSAPS.

More signs diabetes drug linked to bladder cancer

Quoted from http://www.reuters.com/article/2011/05/13/us-diabetes-drug-cancer-idUSTRE74C6VF20110513

More signs diabetes drug linked to bladder cancer

By Alison McCook

NEW YORK | Fri May 13, 2011 5:19pm EDT

NEW YORK (Reuters Health) - A review of official reports of bad drug reactions is revealing more signs that people taking the diabetes drug Actos are at higher risk of developing bladder cancer.

Between 2004 and 2009, more than half a million adverse reactions among people taking anti-diabetic drugs were added to an official U.S. Food and Drug Administration database. Among those reports were 138 instances of bladder cancer in patients taking at least one of more than 15 different anti-diabetic drugs.

However, more than a fifth of those bladder cancers were in patients taking Actos (pioglitazone), suggesting a "disproportionate risk" in comparison with other anti-diabetics, said study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy.

A certain number of people taking a drug will always develop other problems, she explained, and it's often not clear whether those problems stem from the drug itself. As a result, these findings do not show Actos increases the risk of bladder cancer, she cautioned - just that researchers should look into it further.

"Disproportion is indicative of possible risk," Poluzzi told Reuters Health in an email, "not of an actual risk."

Still, this is not the first report to tie the drug to bladder cancer, and the possibility of increased cancer risk is already included in the prescribing information for the drug.

Last year, the FDA began a safety review of Actos after receiving early results from a long-term study by the drug's maker, Takeda Pharmaceutical Co Ltd. That study showed a raised risk of bladder cancer in patients with the longest exposure to Actos, and in those with the highest cumulative dose of the drug.

[Article continues at original source]