A recent report about the high cardiovascular risk associated with the diabetes drug Avandia has caused a steep decline in its sales and resulted in a large increase in the sales of competing diabetes drug Actos. Actos has been so successful lately because it has been perceived as the ‘safer’ of the two options. Both Actos and Avandia are part of the family of drugs known as thiazolidinediones which are used to decrease insulin resistance of body tissues and alter the body’s production of cholesterol.

The study which plagued Avandia originally stated that they didn’t see the same heart failure risks associated with Actos, but new information has come to light regarding Actos and heart failure. A new study published examined the records of over 28,000 patients who took both drugs and determined that there may in fact be a higher risk of heart failure with the use of Actos. Some of the results of the study are as follows:

• 96 patients on Avandia suffered a heart attack, compared with 121 on Actos;
• 265 on Avandia suffered heart failure, compared with 243 on Actos;
• 24 on Avandia suffered both heart attack and heart failure, compared with 18 on Actos;
• 217 on Avandia and 217 on Actos died.

They reported in the journal Circulation: Cardiovascular Quality and Outcomes that, when they accounted for potential confounding effects, including age, gender and prior heart disease, about 4% of each group had a heart attack, heart failure or died. Specifically: “What distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths,” Wertz said in a statement. The study also followed patients for a longer period of time than earlier studies and the patients were younger, she added. Unlike the earlier studies, however, it did not include strokes in the data, which may account for part of the difference in outcomes.

This study about Actos’ risk of heart failure caused the diabetes drug to also be required to carry a ‘black box’ warning about heart failure. A black box warning is the strongest provision that the FDA enacts short of removing a drug from the market. Recent studies have also been published warning of an increased risk of bladder cancer associated with the use of Actos.

Actos Heart Failure Lawsuit

If you or a family member took Takeda Pharmaceutical’s drug Actos (pioglitazone) and you have developed heart failure, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action in a potential Actos heart failure lawsuit against the makers of the drug.

Please fill out our online legal evaluation form to the right or call us and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

According to a clinical study in France, there is an increased risk of bladder cancer associated with Takeda’s drug Actos (pioglitazone). Surveying 1.5 million diabetic patients, this study also found that the risk of bladder cancer sharply increased with usage of over 12 months as well as with increased dosage. Prior to the study conducted in France, bladder cancer was similarly observed in male rats receiving clinical equivalent doses of (Actos) pioglitazone.

As a consequence of these findings, Takeda’s Actos will be completely removed from the pharmaceutical market in France. Similarly, the German Federal Institute for Drugs and Medical Devices has already advised doctors to cease in prescribing Actos to their diabetic patients. While Actos is still currently available in the United States, the FDA has been conducting rigorous safety reviews of the drug and further exploring its alarming and devastating link to bladder cancer.

Additionally, the United States FDA has reacted to the findings of the Actos Study in France by amending the warnings and precautions section of all Actos drug labels to reflect it’s dangerous and previously unreported correlation to bladder cancer. As of 8-4-2011, the FDA announced that their approval of the inclusion that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. Because Takeda first introduced Actos into the market in the 1990’s, this means that many diabetes patients have been using this drug for decades without knowledge of its devastating risk of leading to bladder cancer.

In response to the French data, the FDA declared that healthcare professionals should not prescribe Actos (pioglitazone) to patients with active bladder cancer. In addition, Actos should be used with caution in patients with a prior history of bladder cancer because the benefits of blood sugar control must be carefully weighed against the risks for bladder cancer recurrence.

The hugely popular Actos has ranked among the top ten selling prescription medicines in the United States. In 2010 Actos had sales of over $3.4 billion, and accounted for 27% of Takeda Pharmaceuticals revenue. However, after the alarming results of the recent study in France, the usage of Actos for Diabetes must be carefully weighed against its link to bladder cancer. In the words of Dr. Harlan Krumholz, a Yale School of Medicine professor, “The consensus already is that (Actos) should only be considered … after patients have exhausted all other options.”

Actos Bladder Cancer Lawsuit

If you or one of your family members took Takeda Pharmaceutical’s drug Actos (pioglitazone) and have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at our law firm can inform and assist you regarding legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.

Please fill out our online legal evaluation form to the right or call 1-800-883-9858 and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

Only a week after officials in both France and Germany began restricting the prescriptions of the diabetes drug Actos made by Takeda Pharmaceuticals, the US Food and Drug Administration (FDA) will now require additional warnings that the use of Actos for more than a year might be linked with an increased risk of developing bladder cancer. Only a week prior, a French study with similar findings propelled French officials to suspend the use of Actos and officials in Germany have recommended that doctors not prescribe Actos to new patients.

The statement by the FDA is in response to a 5-year interim analysis of an ongoing 10-year study of Actos risk of bladder cancer. The FDA’s analysis claims that while they don’t see any overall increase risk of bladder cancer with the use of Actos, they noted an increased Actos bladder cancer risk among patients taking Actos for more than a year as well as those taking higher dosages of Actos. French and German studies, however, did claim that there is an overall increased risk of bladder cancer with Actos as well as an even higher risk the longer Actos is taken.

The French decision was made by its version of the FDA, the AFSSAPS which based their move on a study conducted by a national French insurer which examined results of more than 1.5 million individuals between the ages 40 and 79 years old being treated with Actos between 2006 and 2009. France’s move on Actos has triggered a study by the European Medicines agency, the umbrella drug regulatory agency of Europe. Their study is currently ongoing. A further report in an issue of Diabetes Care, reported 93 incidences of bladder cancer among Actos patients in the FDA Adverse Event Reporting system databases spanning between 2004 and 2009.

Between January 2010 and October 2010 more than 2.3 million patients filled a prescription for diabetes drug Actos. Actos has enjoyed great results following the restrictions placed on sister drug Avandia. Actos has been perceived as the ‘safer’ of the two diabetes drug, but new results linking Actos to bladder cancer might change that perception. In addition to being linked with bladder cancer, Actos has also been recently linked to increased heart failure and bone fractures.

Actos Bladder Cancer Lawsuit

If you or a family member took Takeda Pharmaceutical’s drug Actos (pioglitazone) and you have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.

Please fill out our online legal evaluation form to the right or call us and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.