Actos Injuries

Actos has been recalled in the European countries Germany and France due evidence the world’s best selling diabetes medication increases the risk of bladder cancer. While the F.D.A in the United States has only changed the labeling of Actos to reflect the increased risk of bladder cancer.

The minor label change to the U.S. version of Actos by the F.D.A. is a major indication a real problem exists with the drugs intended purpose and its unfortunate side effects. The specific change or addition in this case to the label was, “that the use of pioglitazone (Actos) for more than one year may be associated with an increased risk of bladder cancer.”

The study that triggered the ban of Actos in Europe and caused the not so flattering label change in the U.S. found that Actos increased a patient’s risk for bladder cancer by 40%. This study examined the first 5 years of a 10 year study conducted by Takeda, manufacturer of Actos.

If you have been taking Actos for more than a year please contact our offices so that we may have your information on file for any future actions.

FDA Warns of Bladder Cancer Risk With Actos

Patients taking the diabetes drug Actos for more than a year may have an increased risk of bladder cancer, according to an FDA interim review of an ongoing epidemiological study.

The warning comes just days after two European countries banned use of the drug. The European Medicines Agency (EMA) has yet to release any guidance on use of Actos.

Five-year data show that although there’s no overall increased risk of bladder cancer, patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk, the agency said.

Read this story on www.medpagetoday.com.

Actos is now the second medication in the thiazolidinedione (TZD) class to be associated with serious side effects within the past year. Last fall, the use of Avandia was severely restricted in the U.S. because of concerns about an increased risk of heart attack.

Some researchers suspect that this may prompt physicians to back away from prescribing the class at all, moving toward newer therapies, particularly the incretins, when metformin alone is no longer working for type 2 diabetes patients.

“I will ask my patients on Actos to consider dropping it and give them an alternative,” Dr. Albert Levy of Mount Sinai School of Medicine in N.Y., said in an email to MedPage Today.

Under the FDA’s restrictions last fall, Avanida is to be used only in patients who have failed therapy with Actos.

Researchers say the latest warning probably won’t change that process, but there doesn’t appear to be much interest in choosing between what some see as the lesser of two evils with the drug class.

Dr. Lee Green of the University of Michigan said Avandia has a “solidly established association with heart disease. I wouldn’t switch someone from a drug that might turn out to be a problem [Actos] to one that we know is a problem.”

Dr. David Nathan of Massachusetts General Hospital, said he doubts that Avandia, “a potentially dangerous drug, will replace [Actos] — another potentially harmful drug, if the bladder cancer risk proves to be real — given the numerous other choices to treat type 2 diabetes.”

Instead, many clinicians may move directly to incretin therapy if metformin no longer does the trick.

Levy said he would jump to a GLP-1 agonist like liraglutide (Victoza) or exenatide (Byetta) or DPP-4 inhibitors like sitagliptin (Januvia) for patients who aren’t well controlled on metformin.

Those drugs may pose problems, too. For example, on Tuesday, the FDA issued a warning about the risks of thyroid cancer and pancreatitis associated with liraglutide.

Sue Kirkman, MD, vice president of medical affairs for the American Diabetes Association, said just prior to the FDA’s recent decision that the evidence of bladder cancer risk with pioglitazone has been “conflicting, and it’s hard to know whether this is real problem or not.”

She said her organization’s main concern is that patients might stop taking their medication after hearing the news about the increased risk rather than talking to their doctors first.

Still, Kirkman acknowledges that some of the clinicians her organization represents have made the decision not to use the class, or have at least given it serious consideration before prescribing.

“We already knew there were other issues with the class, aside from those seen with rosiglitazone,” she said. “There are concerns about fractures, fluid retention, and congestive heart failure.”

But not all clinicians were quick to decry use of Actos or the TZD class. Dr. Joel Zonszein of Albert Einstein College of Medicine in New York City called the earlier European decision “precipitous and premature” because it was based on a retrospective study and found only a minor increase in cancer risk.

He added that triple therapy — with metformin, a TZD, and incretins — is an “excellent combination, particularly in the more aggressive type 2 diabetes we see nowadays.”

“During the last three decades, studies have shown that treating diabetes early and aggressively results in much better outcomes,” Zonszein said. “There is a need for medications such as Actos that can slow down the devastating results of the diabetes epidemic.”

Green said that while the recent decisions in the U.S., France, and Germany have made his “antennae go up,” they won’t yet change his prescribing. He said he also hears a greater public health message within the controversy.

“I think the larger message is not about which drugs for diabetes, but about the ultimate foolishness of trying to fix the problem with drugs,” Green said. “As long as we keep supersizing ourselves, eating too much and moving too little, we’ll have this problem.”

The FDA began its review of Actos and the potential risk of bladder cancer last September, and said it will continue to monitor data until the full 10-year study is complete.

British MHRA issues ACTOS bladder cancer warning

A warning has been issued over the diabetes medication pioglitazone (Actos) after it was linked with a small increased risk of developing bladder cancer.

The UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) says patients should not stop taking pioglitazone without seeing their doctor. Patients receiving pioglitazone should immediately report any visible blood in their urine or bladder problems such as pain while urinating or urgency to urinate, to their doctor. Patients receiving pioglitazone will have their treatments assessed by their doctor at their next routine appointment.

The review found that there is a small increased risk of bladder cancer associated with taking pioglitazone, but it is not clear if the risk increases early in treatment or only after prolonged use.

However, it says if patients are selected carefully for this treatment, the benefits continue to outweigh the risks. Pioglitazone should not be used in patients with a history of bladder cancer or in patients with uninvestigated visible blood in the urine. This applies to those being considered for pioglitazone treatment and those already receiving it.

Doctors will be told to review the safety and efficacy of pioglitazone for patients after three to six months of treatment to ensure that only patients who are getting a benefit continue to be treated. Patients who are already receiving pioglitazone will also be monitored. Pioglitazone should be stopped in patients who do not respond adequately to treatment.

European Medicines Agency (EMA) urges new warnings about possible link to bladder cancer

http://www.reuters.com/article/2011/07/21/takeda-actos-idUSL3E7IL3II20110721

(Reuters) – Takeda Pharmaceutical’s diabetes pill Actos should carry new warnings about its possible link to bladder cancer, Europe’s drug regulator said on Thursday, following a safety review of the medicine.

The Japanese company’s medicine remains a valid treatment option for certain patients with type 2 diabetes, despite the small increased risk of bladder cancer, the European Medicines Agency (EMA) said.

The EMA said the risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient’s treatment.

Last month both France and Germany suspended use of Actos and Competact — which combines Actos and an older drug called metformin — after an official French study found a link to a slightly increased risk of bladder cancer.

Other European countries, however, decided to hold fire pending a decision by the EMA.

Takeda said it would update its physician and patient information for Actos, known generically as pioglitazone, once the new recommendations from the EMA were endorsed by the European Commission.

“Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications,” the company said in a statement.

The U.S. Food and Drug Administration said recently it was adding information to the drug’s label about the potential risk of bladder cancer from long-term use, while keeping the product on the market for the time being.

The FDA initiated a safety review of Actos last September, while its European counterpart started a probe in March.

Actos had global sales of 387.9 billion yen ($4.8 billion) in the year ended March 31, accounting for 27 percent of Takeda’s revenue.

It belongs to the same drug class as GlaxoSmithKline’s Avandia, which was pulled from the market in Europe and had severe restrictions imposed on its use in the United States last September after being linked to heart risks.

GSK’s drug has not been associated with bladder cancer.

Actos was approved for use in Europe in 2000 but its potential bladder cancer risk, seen in tests of male rats, has long been a topic of discussion. (Reporting by Ben Hirschler; Editing by Hans-Juergen Peters and Will Waterman)

If you or a loved one has experienced heart related or bladder cancer side effects or complications while using ACTOS please contact us using our contact form or simply give us a call at  1-866-373-1800.