Actos®, a brand name for the drug pioglitazone, was given to patients to control their Type-2 diabetes. The drug acted as a supplemental treatment when diet and exercise was not enough to curb symptoms. Actos belongs to a class of drugs called Thiazolidinedione that lower blood glucose levels. The result raises the body’s sensitivity to insulin. Patients were prescribed this drug as a sole treatment or in conjunction with other insulin monitoring drugs.
For people with Type-2 diabetes, reducing their blood glucose levels is vital to keep them from being vulnerable to more severe health complications like blindness, kidney failure and cardiovascular disease. Between 18 and 20 million Americans are affected by Type-2 diabetes. Actos was supposed to be a solution that allowed people to resume their normal lives, but the side effects limited the effectiveness of the drug.
Actos Health Problems
Actos (Pioglitazone) is used to treat type 2 diabetes. It works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels. However, some patients have experienced serious Actos side effects such as bladder cancer. The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos.
The warning about Actos side effects comes after a review of data from a five-year interim analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals. The results suggest that Actos side effects may cause users to face an increased risk of cancer when the medication is taken for a longer period of time and/or in high doses.
What is Actos®?
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.
Actos Increases Your Risk of Cancer
Takeda Pharmaceutical Company and Eli Lilly Pharmaceuticals are responsible for the distribution and marketing of the oral diabetes medicine Actos. The dangers surrounding Actos caused the Food and Drug Administration (FDA) to issue a statement requiring that the makers of the drug include a black box warning on every package. This type of warning is the highest level of caution the FDA makes before conducting a full recall.
After further study, the FDA released a safety alert to warn patients and healthcare professionals about the high risks associated with Actos and pioglitazone drugs. They have concluded that a prolonged use of the drug (over a year) may result in increased chances of bladder cancer. This was also confirmed by the national French Agency for Safety of Health Products. Germany’s Federal Institute of Drugs and Medical Devices has taken more advanced measures by instructing doctors not to prescribe Actos until a conclusive investigation is complete.
Researchers have not been able to verify an exact cause for bladder cancer. However, they have linked it to patients who have had a history of smoking, chemical exposure and Actos consumption.
The Effects of Bladder Cancer
Bladder Cancer is a painful and uncomfortable disease. Research has found that long term irritation produces tumors that begin along the lining of the bladder. As the tumors grow, they multiply and invade the three layers of the bladder – disabling the bladder’s ability to properly function. Patients with bladder cancer may experience a variety of symptoms:
- Urinary frequency
- Abdominal pain
- Blood in the urine
- Bone pain or tenderness
- Painful urination
- Urinary urgency
- Incontinence (urine leakage)
- Weight loss
A combination of surgery, radiation and chemotherapy are used to treat bladder cancer depending on its progression stage. This includes months of painful hospital visits resulting in mounting financial obligations, which many cannot afford without assistance.
If the cancerous tumors persist they can spread and infect other vital organs. This makes treatment very difficult, and patients could lose their bladders and even their lives to this destructive disease. If you experience any of the above symptoms and have taken Actos, seek medical advice immediately.
Legal Help for Victims of Actos
If you have or are currently taking Actos you could be at risk. You need to contact an actos attorney for a case evaluation. If you are entitled to compensation, they will ensure that you get the help you need.