Actos is a medication made by Japanese drug maker Takeda. It is used to treat type 2 diabetes by lowering and regulating blood sugar levels. Takeda has earned billions of dollars in revenue for Actos since it was approved in the U.S. by the Food and Drug Administration (FDA) in 1999. As the number of people living with type 2 diabetes has grown, so has the demand for medications that lower blood sugar.
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.
Actos for Type 2 Diabetes
Type 2 diabetes is a chronic condition characterized by high blood sugar levels, which over time can cause serious and life-threatening complications. Controlling and lowering blood sugar is crucial to treating and even overcoming this illness. Drugs like Actos were designed to lower blood sugar levels, but also to be used along with lifestyle changes that do the same, like exercise, a healthy diet, and weight loss.
Actos is the generic drug pioglitazone, a member of the thiazolidinedione class of medications. These are drugs that increase sensitivity to insulin. Insulin is the hormone released by the pancreas in response to high blood sugar, and in healthy people keeps blood sugar levels normal. In someone with type 2 diabetes, sensitivity to the hormone has decreased.
Complications Associated with Actos
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.
One very serious complication of pioglitazone is congestive heart failure. This condition occurs when the heart cannot pump blood as well as it should, and it can be fatal. A black box warning was placed on Actos packaging at the behest of the FDA because of the seriousness of this possible side effect. Although Actos was on the market starting in 1999, this warning didn’t come out until 2007.
Many people have sued Takeda over congestive heart failure because they believe they were not adequately warned about it. The risks are particularly high for those patients taking Actos who already have congestive heart failure or who are at risk for it. It took so long for a warning about the risk to come out because initial evidence came from individual reports only. Eventually those reports led to studies, which confirmed the risk is associated with Actos.
The other very serious potential complication of Actos is bladder cancer. This has also been the source of lawsuits against Takeda because the outcome can be so serious and people feel they weren’t adequately warned about the possibility. Takeda got into hot water over bladder cancer because emails came to light showing that the company knew about the risk as early as 2005, yet no warning existed on the packaging. The warning is there now, but after many people suffered from bladder cancer.
Recalls in Europe
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.
FDA and Takeda Study and Call for Ban
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.
Although the FDA and Takeda have taken the official stance that the risk of bladder cancer is low to non-existent, the company is nevertheless facing numerous lawsuits. Thousands of lawsuits have been filed against Takeda over bladder cancer, as well as the other complications like heart failure. While Takeda admits no wrongdoing and declares Actos to be safe, it has paid out settlements over bladder cancer.
If you believe that using Actos harmed you in some way, you may be able to join or start your own lawsuit to seek compensation from Takeda. A recall may or may not be in the future for Actos, but if you have already suffered because of this drug, a recall won’t affect you anyway. Let a lawyer guide your next steps and help you decide if a lawsuit is the right move.