By: Taylor Bartlett
Actos is a single ingredient brand name drug composed of Pioglitazone. Pioglitazone was developed, manufactured, and advertised by Takeda Pharmaceutical Company, the parent company of several US Takeda entities. Takeda Pharmaceutical Company is a company headquartered in Japan. Until April 20, 2006 Eli Lilly and Company was in collaboration to market and sell Pioglitazone within the United States.
Pioglitazone (Actos) can be found in combination with other drugs under the following brand names: ActoPlusmet, ActoPlusmet XR , and Deutact. It is within the Thiazolidinediones class (“TZD’s”). Avandia and Rezulin are two notorious TZD’s. Its approved use is to treat Type II Diabetes by exerting an antihyperglycemic effect only in the presence of endogenous insulin.
The FDA approved Pioglitazone for use on July 15, 1999, for the treatment of Type II Diabetes. It was fast tracked through the approval process mainly because of its similarity to other TZD class drugs. Numerous human clinical trials were conducted but no bladder cancer study was published prior to approval. Studies conducted on lab rats, however, indicated that bladder tumors in male rats developed after exposure to Pioglitazone.
In 2005, the results of the PROactive (PROspective Pioglitazone Clinical Trial In Macro Vascular Events) three-year study were published. The study, funded in part by Takeda and / or its partners, was intended to investigate the impact in total mortality and macrovascular morbidity on humans ingesting Actos. During the course of the study, the researchers became aware that there was a statistically significant increase in bladder cancer occurrence in Actos users.
In 2010, a planned five year interim study on the association between Actos ingestion and bladder cancer was concluded. It was a longitudinal cohort study funded by Takeda that evaluated 193,099 Kaiser Permanente Northern California patients who were older than 40. Of those patients, 30,173 were treated with pioglitazone. The results indicated that Actos use for longer than 48 months results in a 1.7 increased risk – fully adjusted. It also showed that Actos use for more than 24 months resulted in a 1.4 increased risk – fully adjusted. There was no noticeable difference in bladder cancer risk based on the sex of the Actos user. Also, no clear pattern arose between increasing time since initiation of Actos use and bladder cancer risks. On September 17, 2010, the FDA issued a safety announcement indicating that it was undertaking review of the data. The report on this study was published in April 2011.
In response to Avandia’s bad press, a study looking at the association between Pioglitazone use and bladder cancer was conducted that reviewed adverse events submitted to the FDA from 2004-2009. The study found that there was a “definite signal” between Pioglitazone use and bladder cancer. This study noted a significant relationship even prior to the publication of other bladder cancer studies.
The French medical authorities reported in June 2011 that a greater than one year use of Actos increases risk of bladder cancer by 40%. During that month, France and Germany banned Actos and the FDA finally announced that greater than one year use of Actos may be associated with increased risk of bladder cancer. In August 2011, the FDA required new warnings for Actos which define the bladder cancer risks. On the same day, the FDA recommended to healthcare professionals that they be especially careful when prescribing Actos to patients with a history of bladder cancer. Takeda, in July 2011, recognizing the dangers of Actos recalled the drug in France. Actos is one of Takeda’s top selling drugs and has had global sales of approximately 4.8 billion and accounted for approximately 27% of Takeda’s revenue. As of today, Takeda has failed to recall this dangerous drug and is facing surmounting criticism and scrutiny for its manufacturing of this dangerous drug.
If you are anyone you know has taken Actos (or any of its combination drugs) and developed any type of bladder problem after ingesting it, call the law firm of Heninger Garrison Davis, LLC at 1-800-241-9779.