Actos (pioglitazone) is an oral diabetes medication in the class of drugs known as thiazolidinediones (TZD). Diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Takeda’s Type 2 Diabetes drug, Actos (pioglitazone), grew in popularity after the use of Avandia, GlaxoSmith Kline’s controversial drug, was severely restricted in the United States because of concerns of an increased risk of heart attack and heart failure. By late 2011, Avandia was no longer available through retail pharmacies. And then came Actos.
Waiting one day after Avandia received restrictions from the FDA, Takeda began a new advertising campaign for its diabetes product Actos. Boasting taglines such as “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke,” diabetes sufferers quickly shifted from Avandia to Actos. However, like Avandia before it, the safety issues surrounding Actos have come to the attention of the FDA and have left the public questioning whether there is a diabetes drug worth the risk.
Actos Bladder Cancer Risk
On June 15, 2011, the FDA issued a Drug Safety Warning with regards to an increased bladder cancer risk associated with the use of the diabetes drug, Actos. This warning came after a review of data from a five-year interim analysis of an ongoing study of Actos by Takeda.
In the same year, Takeda was named in more than 10,000 Actos-related lawsuits.
The results showed that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer amongst those who had used the drug the longest. Independent researchers discovered that Actos users have a 40% higher chance of developing cancer after they have taken the drug for longer than a year. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
Before the FDA warning – several European Markets, France and Germany, suspended the use of Actos, citing concerns over an increased risk of patients developing bladder cancer.
Studies continued to point toward Actos bladder cancer risks. On July 5, 2013, an international independent study was published finding Actos to be “probably carcinogenic.”
In June 2013, 23 experts from nine countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of fourteen drugs and herbal products. After a detailed review of one large randomized controlled study, four cohort studies, and three case-controlled studies, the Agency determined that pioglitazone (the active ingredient in Actos) should be classified as “probably carcinogenic” to humans based on the evidence that it causes bladder cancer.
Takeda had profited from sales of Actos in the U.S. of over $3 billion in 2009 and just under $3 billion in 2010.
Side Effects Associated with Actos
Possible side effects associated with Actos include:
- Low blood sugar
- Liver problems
- Bladder cancer
- Broken bones (fractures)
- Diabetic eye disease with swelling in the back of the eye (macular edema)
- The release of an egg from an ovary in a woman (ovulation) leading to pregnancy
A 2008 Swiss medical study was the first to uncover a link between Actos and bone fracture, finding that the drug could cause a double or triple risk of bone fracture in patients.
In 2010, Actos was linked to 243 cases of heart failure and 121 heart attacks.
What are diabetics supposed to do? Is there a drug to help with the suffering that doesn’t set them up for new injuries? What drugs can they safely turn towards to alleviate their struggles? Sadly, it appears there is no clear answer at this time. Given the history of diabetes drugs, diabetics have to seriously question and monitor the release of new diabetes medications, especially when the FDA is already requesting additional research.
Today’s diabetic must be informed. If you are a diabetic, your focus should remain on your health. It is always advisable to discuss any risks and concerns with your physician.
Actos Bladder Cancer Lawsuit
The Actos bladder cancer lawsuit is largely inactive. As of January 2018, only 18 cases remained in the federal court in Louisana. TorHoerman Law is no longer accepting Actos cases. If you have any questions, contact us.
Actos Bladder Cancer Lawsuit Settlement
TorHoerman Law, one of the lead negotiators in a $2.4 billion settlement deal with Takeda, released a press release announcing the completion of a historic Actos bladder cancer lawsuit settlement. Read the Press Release Here.