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A Third Actos Generic to Begin Posing Cancer Risk

October 25th, 2012

A federal judge has said a third company can begin selling Actos generics immediately – even after the Food and Drug Administration (FDA) said otherwise.

Watson Pharmaceuticals was initially denied the approval to sell the drug by the FDA in order for two other companies — Mylan Inc. and Ranbaxy Laboratories Ltd. — to have six months of exclusive marketing time in accordance with a law that allows generic drug companies to do so. But Watson sued the FDA in August, challenging the agency’s decision to grant other companies that exclusivity.

Now, Watson will add its version of pioglitazone hydrochloride, the active ingredient in Actos, to those already approved and on shelves. But don’t be fooled. Just because another company is making a generic product doesn’t mean it’s skirting the serious risk of developing bladder cancer associated with the Takeda and Eli Lilly & Co. brand-name drug. Read the rest of this entry »

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Consumer Reports: Avoid Actos — and its Generics — At All Costs

October 5th, 2012

Even after the FDA approved generic versions of Actos in August, a nonprofit consumer watchdog group said you should “skip” them.

The FDA approved pioglitazone hydrochloride tablets to treat type 2 diabetes this summer, despite links between its brand-name version, Actos, and a 40% increased risk of bladder cancer after a year of use. The generic’s label warns about the increased risk, the FDA said, but a report published soon after the drug’s approval said patients should look elsewhere for treatment.

The Risk Is Too Great

Consumer Reports, a nonprofit watchdog publication that circulates to more than seven million readers, warned patients against using Actos, which is manufactured and marketed by Takeda and Eli Lilly & Co. as well as its new generics, mainly because of the increased risk of bladder cancer. Read the rest of this entry »

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Canadians Taking a Stand Against Actos

September 12th, 2012

Jimmy Whyte, a Canadian man, petitioned for a class action lawsuit against Takeda Pharmaceuticals and Eli Lilly & Co., the manufacturers and distributors of Actos.

Whyte had been taking Actos for type 2 diabetes starting in November 2008, and by April 2012 he was diagnosed with bladder cancer. Last year, the U.S. Food and Drug Administration updated the labels on Actos to specify that if used for more than one year, the drug may be associated with an increased risk of bladder cancer.

This label update came too late for people like Whyte.

“It would have been important to know that Actos would increase my risks of developing bladder cancer before I began taking it,” Whyte said in a news release. “I believe this class action is necessary to determine whether the manufacturer of this drug should be held responsible for not disclosing such important information to me.”

Doctors continue to prescribe this drug to patients, although its use has been limited. The drug’s makers, Takeda and Eli Lilly & Co., know the risks but yet still push the drug out for treatment of type 2 diabetes and in clinical trials for the treatment of Alzheimer’s. What will it take for these drug companies to remove this drug as a treatment option? Read the rest of this entry »

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Miracle Drug or Risky Business?

September 7th, 2012

Alzheimer’s is a disease that affects the memory, thinking and actions of an individual. Scientists have studied the disease and have found that the disease involves progressive brain cell failure, but the reason why is still unclear. Loved ones of those with Alzheimer’s long for a cure to help the 5.4 million Americans living with this mysterious disease.

Hopeful for the Miracle Treatment

Since the disease is very much in need of a cure, the talk of a new drug treatment has created much attention. Takeda Pharmaceuticals has announced that they will begin clinical trials using the drug Actos for the treatment of Alzheimer’s. Read the rest of this entry »

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Actos Gets the Maple Leaf Stamp of Disapproval

July 27th, 2012

The United States’ “neighbors to the north” are among the growing number of countries from which extensive research has emerged linking bladder cancer to Actos.


One Canadian province has already restricted access to diabetes drug Actos, and the others are likely to follow. In April 2012, the Ontario Public Drug Program limited patients’ access to Actos, announcing that it would do so by putting Actos on its Exceptional Access Program (AEP). This is not like the “E” for exceptional we all wanted on our grade school report cards! Placement on this list means that doctors can no longer prescribe Actos, and patients who want it must submit a request to EAP explaining why use of Actos is necessary.

This follows the June 2011 announcement that Canadian health officials launched a review of Actos’ bladder cancer risk. Read the rest of this entry »

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Blind Eye to Risks: Actos Linked to Vision Problems

June 13th, 2012

Amidst the nationwide filing of Actos bladder cancer lawsuits, the rumors that Actos is linked to an increased likelihood of heart attack like Avandia, and the latest study that reveals Actos-induced vision problems, we are beginning to wonder, did Takeda Pharmaceuticals study the risks of Actos at all?

Of course, we assume that for the FDA to approve Actos in 1999, manufacturer Takeda must have met some burden of proof that Actos was a safe treatment for type 2 diabetes.

But now it is clear that the question of Actos’ safety is met with more uncertainty and concern than answers and assurances.

Actos Users Face Doubled Risk of Vision Problems

A new study by British researchers reveals that use of thiazolidinediones –medications like Actos and Avanda, that manage blood sugar levels for diabetics – may result in eye problems. Read the rest of this entry »

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Plot Thickens in Dangerous Diabetes Drugs Scandal

June 1st, 2012

  • A Takeda researcher who is fired after raising concerns about the integrity of her company’s safety reports.

  • A well-respected cardiologist with questionable industry ties.

  • A damning medical study that destroys the profits for one drug company, and sends the competitor’s sales to record highs.

These are all pieces and players in the increasingly complicated mystery surrounding the safety reports that are currently coming under scrutiny regarding diabetes drugs Actos and Avandia. Read the rest of this entry »

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Actos Manufacturer Strikes Out Again

May 4th, 2012

Takeda Pharmaceuticals, maker of Actos, tried to slip one past the Food and Drug Administration (FDA) again, but this time the Agency isn’t having it. Last week, the FDA denied approval for alogliptin, a drug created to take the place of Actos as Takeda’s number one diabetes drug, according to The Chicago Tribune.

This rejection announcement marks the second time that the Japanese drug giant has been shot down by the FDA for clearance of their new drug, which is already being marketed in Japan. The FDA denied approval for alogliptin the first time Takeda applied to license the drug in the United States in 2009. Both times, the regulatory board has sited insufficient data to support the safety of the drug. Read the rest of this entry »

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New Bladder Cancer Treatment Saves Woman’s Life

May 1st, 2012

Wendy Powell was just 36 years old when she was diagnosed with life-threatening bladder cancer. The diagnosis was made after doctors discovered a tumor that was roughly the size of a lemon in the British woman’s bladder.

“When I was told I had bladder cancer it was a bit of a shock at first. They went through all the options for treatment and when they mentioned the trial I decided to give it a try,” Powell told the Birmingham Mail.

Wendy Powell, photo courtesy of Birmingham Mail

From Trial Drug to Cancer Free

The trial that Ms. Powell refers to was a bladder cancer research study, conducted by the University of Birmingham and the Institute of Cancer Research in the UK, and released just last week. Perhaps because of this study, Ms. Powell and dozens of other patients are still alive today, having survived their bout with bladder cancer.

Today, Wendy Powell is 49 years old and works in the Cadbury factory in Bournville, England. It has been 13 years since her diagnosis, and she is currently clear of cancer, but is undergoing continual monitoring to ensure the cancer does not return.

“I’m back to normal now, and it’s thanks to clinical trials that more people are surviving like me. I’m all for trials. It’s really good they’re coming up with new ways of treating the disease.”

Though this new treatment shows great promise, it is not without challenges. Read the rest of this entry »

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Doctor Calls for Prosecution of Dishonest Pharma Companies

April 21st, 2012

How is it that pharmaceutical companies are able to market drugs even after they are aware of dangerous and potentially life-threatening side effects? What is wrong with our consumer protection system that allows these companies to get away with such negligence and immorality?

These were some of the important questions that were raised at a recent American College of Cardiology scientific session, during a stirring presentation given by Steve E. Nissen, MD. Dr. Nissan chairs the department of cardiovascular medicine at the Cleveland Clinic. His talk focused on a key question in medicine today: When should devices or medicines that are known to cause injury cease to be used in practice? Read the rest of this entry »

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Lawyers Picked to Manage Actos Lawsuits

March 21st, 2012

More headway has been made on the Actos bladder cancer lawsuit front. Honorable Rebecca Doherty, the judge responsible for overseeing lawsuits alleging Takeda Pharmaceuticals’ Actos causes bladder cancer, has taken the next step in the litigation process. The judge has appointed 19 plaintiffs’ lawyers into various leadership roles to manage the Actos multi-district litigation (MDL), according to a Bloomberg article. Lawsuits against Takeda, and co-defendant Eli Lilly & Co., were consolidated last December, and court records indicated that the first hearing on the cases is set for March 22.

Among those appointed are Richard Arsenault and Paul Pennock, chosen as lead counsel for plaintiffs. Both Mr. Arsenault and Mr. Pennock have successfully obtained multi-million dollar settlements against other pharmaceutical companies, a promising sign for Actos victims who are part of the litigation. Read the rest of this entry »

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Actos Bladder Cancer Lawsuits Expected to Flood the Courts

February 28th, 2012

The significant number of Actos bladder cancer lawsuits has spurred a Louisiana federal judge to invite lawyers who are interested in serving on a committee within the consolidated multidistrict litigation. According to an Associated Press news report, plaintiffs’ attorneys are expected to file several thousand claims against Takeda, Eli Lilly and other pharmaceutical companies that make the diabetes drug Actos, which has been linked to bladder cancer.

The Food and Drug Administration (FDA) issued a warning in 2010 about the drug’s cancer risks. Although Actos sales were halted in Germany and France, that has not been the case in the United States. The drug received FDA approval in 1999 for treatment of Type 2 diabetes and continues to be sold here, despite the serious, potentially fatal bladder cancer risk. Read the rest of this entry »

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Actos Lawsuits Heating Up

February 3rd, 2012

In December 2011, Actos lawsuits were consolidated before District Judge Rebecca Doherty in the Western District of Louisiana, several months after a motion to consolidate was filed by Actos victim Glen Weant.

The Western District of Louisiana was chosen for several reasons, including the benefit of currently having no other pending multidistrict litigations (MDL) in that district. This means Honorable Judge Doherty will be able to devote her attention and the court’s resources solely to this MDL. Although only 54 cases have currently been filed against Actos, it is anticipated that the total number of cases could potentially reach as many as 10,000.

actos lawsuits

Takeda Intentionally Withheld Information, Say Actos’ Bladder Cancer Victims Read the rest of this entry »

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A Look at Studies Linking Actos to Bladder Cancer

September 26th, 2011

Although Actos is currently the number one-selling diabetes drug in the United States, recent research raises serious questions about the safety of drug. Of primary concern, in the past few years, several scientific studies have linked Actos – either long-term treatment or at the highest cumulative dose –to an increased risk of developing bladder cancer.

actos linked to bladder cancer

FDA Announces Bladder Cancer Risk for Actos Users

In the summer of 2011, the FDA issued a safety announcement informing the public that the use of Actos (also called pioglitazone) may be associated with an increased risk of bladder cancer. In the warning, the FDA cited a five-year analysis of a 10-year study of 193,099 patients being conducted by Actos manufacturer Takeda. A five-year analysis of this ongoing study found that the risk for users of Actos to develop bladder cancer was

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54 Actos Lawsuit Claims Filed, MDL Agreed Upon

September 19th, 2011

On August 31, 2011, plaintiff Glen Weant and his wife, Nina, filed a motion to consolidate the Actos bladder cancer litigation into a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Illinois before Judge G. Patrick Murphy. Attorneys representing Actos manufacturer Takeda Pharmaceuticals have responded in agreement to the request for consolidation, but have asked for the cases to be transferred to the Northern District of Illinois or the Western District of Louisiana.

Documents filed by Takeda in late September showed that the drug company is now aware of at least 54 Actos claims that have been filed in federal district courts through the U.S. These complaints allege that Actos use led to users developing bladder cancer, and that Takeda failed to properly research the medication’s safety or warn of the cancer risk.

Why File an MDL?

An MDL is a consolidation of plaintiffs (those who filed the claim) with similar cases against the same defendant. Read the rest of this entry »

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