ACTOS RECALL

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ACTOS RECALL

Actos has not been recalled in the United States, nor does it seem likely in the near future. Takeda Pharmaceuticals, the company that manufactures Actos, stated that the FDA has not signaled any intention of recalling the product and announced that it is not taking Actos off the market in the United States.

Actos has been available in the U.S. since 1999 and is commonly used in combination with diet and exercise to treat Type 2 diabetes in adults. Actos (pioglitazone) is manufactured by Takeda Pharmaceuticals and works by increasing the sensitivity of muscle, fat, and liver cells to insulin. Actos belongs to the same class of drugs as Avandia, a Type 2 diabetes drug that was recalled due to its association with serious cardiovascular risks, including heart attack.

Unfortunately, although effective, Actos has also proven to be risky. It increases the risk of a patient experiencing congestive heart failure, liver failure, and even bladder cancer. These complications have led to numerous lawsuits and even recalls in some countries, including Germany and France. The FDA has not yet issued a recall in the U.S., but some people believe that Actos should be banned over the damage it causes to too many patients.

Using Actos to treat type 2 diabetes comes with some side effects, but most are not serious. Luckily most people tolerate it well and see their blood sugar levels lowered. On the other hand, too many patients suffer serious consequences of using Actos, and it is these that have led to recalls in some countries and a call for a recall in the U.S.

The FDA has issued several warnings about Actos, but the agency has so far stopped short of recalling the drug. European countries Germany and France, on the other hand, have found the evidence of the risk of bladder cancer compelling enough to issue recalls and bans of Actos. Both countries pulled the drug from the market in 2012.

The European Actos recalls came after study funded by the French government confirmed the risk of bladder cancer. The study followed type 2 diabetes patients taking Actos between 2006 and 2009. The results of the study found that these patients had a 22 percent increased risk of developing bladder cancer as compared to patients using other diabetes medications.

Many people in the U.S. have called for a similar recall and ban of Actos, especially after the results of studies connecting it to bladder cancer have revealed the extent of the risk. Backed by the FDA, Takeda has spent ten years studying the risk of bladder cancer. The review began in 2003 and concluded in 2013. The company claims that its extensive study shows no connection between Actos and bladder cancer, a direct contradiction to the French study and previous warnings from the FDA.

In 2010 the FDA announced that early evidence from the ten-year study did show a connection between bladder cancer and Actos use. The FDA could not make a direct conclusion at that time, but did see evidence that it was possible and that it would back up what the French study found. Why the study at the midpoint showed a link and at the end of ten years does not, remains a mystery. Many critics of Takeda believe that the risk is real and that Actos should be banned and recalled from the U.S. market.

ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.

This Medication Guide summarizes the most important information about ACTOS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOS that is written for healthcare professionals. For more information, go to www.actos.com or call 1-877-825-3327.

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Recently France and Germany have issued a recall for Actos due to increased incidence of bladder cancer. In the United States, the FDA has been reviewing the potential side effects of Actos. Studies have indicated that increased risk of bladder cancer is of statistical significance, and new warnings are now required. The FDA determined that taking Actos for 12 months or longer increases risk of bladder cancer by 40%. The risk increases with dosage and treatment duration. Since mid-June, 2011, the FDA acknowledged that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. The FDA now recommends that these Actos medications not be used in patients with active bladder cancer, and used with caution in patients with a prior history of bladder cancer. The new labeling information was approved by the FDA on or about August 4, 2011.

While Actos has been recalled in France and Germany, it remains under investigation by the United States Food and Drug Administration (FDA). To discuss this matter or any of the symptoms you or a loved one may be experiencing after taking Actos, please call one of our experience trial attorneys at 800-460-2756 (toll free). Alternatively, you may fill out our online form and we will be happy to contact you. Our trial attorneys have vast experience in pharmaceutical litigation and are here to help.

About the same time, France released the results of an epidemiological study also indicating an increased risk of Actos bladder tumor in patients taking the drug. France subsequently issued an Actos recall, and Germany suggested physicians issue no new prescriptions soon after.

Despite being linked to cancer, heart failure and other serious side effects, the FDA has not issued a recall for Actos. However, health officials in France and Germany have already stopped or severely restricted sales of Actos due to data about the risk of bladder cancer associated with the medication.

Actos is a widely prescribed diabetes drug that has been shown to increase the risk of bladder cancer by as much as 40% when taken for a year or more. Because of the known side effects of Actos, France has banned it and Germany has warned that new patients should not start taking it. In addition, the U.S. Food and Drug Administration (FDA) issued a warning on June 15, 2011 about the risks of Actos (e.g., bladder cancer). Consumers need to know that even though the FDA has not issued a recall, there are still serious consequences associated with taking this drug, including bladder cancer. An experienced Phoenix bladder cancer defense lawyer can assist you if you have been a victim of this risk.

At the law offices of Pitman, Kalkhoff, Sicula & Dentice, our team of highly trained defective drug attorneys have DETAILED knowledge of the most current drug recalls and are currently offering FREE consultations to help determine if you have grounds to file a damages lawsuit.

In the summer of 2011, the world exploded with new news about Actos bladder cancer. The French Medicines Agency, after reviewing data from the national insurance program, announced an Actos recall because of the risk of bladder cancer. Germany used the same data to recommend that physicians write no new prescriptions for the drug. And the FDA issued a public health communication warning that Actos may increase the risk of bladder cancer, particularly in those patients who take high doses, or who take the medication for over a year.

As a result of the findings, the FDA asked the drug manufacturer to remove it from the U.S. market and issued a recall. The agency instructed patients taking Belviq to immediately stop using the drug and to safely dispose of any leftover pills.

In February 2014, the FDA launched an investigation into the potential risks associated with Onglyza. The findings may require the manufacturer to update the warning labels, or even lead to a recall of the drug. 041b061a72