Diabetes drugs are big business because so many people need help controlling their blood sugar. But one popular drug has come under fire. What’s the latest update on Actos and bladder cancer?
The diabetes drug Actos (pioglitazone) has been controversial for years because of a potential link to bladder cancer. On June 15, 2011 the FDA issued the following safety communication:
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”
Drug regulators in France and Germany banned Actos a few years ago but the FDA sidestepped this action. Not surprisingly, this ambiguity has left many patients in the U.S. confused and concerned.
On April 29, 2015 the company that makes Actos announced:
“Takeda Pharmaceuticals U.S.A., Inc., today announced that they have reached an agreement expected to resolve the vast majority of ACTOS (pioglitazone HCl) product liability lawsuits pending against Takeda in the U.S. Takeda will take a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014 to cover the settlement and the costs associated with defending remaining cases and for other related litigation.”
A U-Turn and “All Clear” on Actos and Bladder Cancer:
On July 31, 2015 Takeda Pharmaceutical Company, announced the results of a 10-year post-marketing study:
“Findings demonstrate that there is no association between the use of pioglitazone and the risk of bladder cancer. These results are consistent with those of a 10-year, prospective cohort study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanent Northern California, which demonstrated no increased risk of bladder cancer among patients ever exposed to pioglitazone.”
Doctors and Patients Completely Confused:
What a mess. First doctors and patients were told that Actos was a very good drug for people with type 2 diabetes. Then they were told that there might be a connection between Actos and bladder cancer. Some European countries decided to ban sale of the drug. The company announced it was setting aside $2.7 billion to settle lawsuits. Then, three months later, it announces, there is no reason to worry about any relationship between Actos and bladder cancer.
Another U-Turn on March 30, 2016:
Now, however, a study published in the BMJ shows a 63 percent increased relative risk associated with Actos and bladder cancer. Almost 150,000 people were followed for up to 14 years. The investigators concluded that the longer people took this drug and the higher the dose, the greater the risk. The absolute risk remains low, but this study seems to confirm that there is indeed a connection between Actos and bladder cancer (BMJ, March 30, 2016).
If your head is spinning, we’re not surprised. This kind of on again, off again, on again risk assessment is enough to make everyone confused. Because it is so hard to study the long-term effects of medications on cancer risk it is hardly any wonder that patients are left holding the bag. Here is an article that we wrote on how the FDA handles the confusing problem of medicines and cancer that you may find of interest.
Other Side Effects of Actos:
- Heart failure (Fluid retention, edema, swelling in ankles or legs, shortness of breath)
- Liver damage (Nausea, stomach pain, loss of appetite, dark urine, yellow skin)
- Symptoms of low blood sugar (hypoglycemia) such as shakiness, dizziness, lightheadedness
- Headache
- Upper respiratory tract infection, cold-like symptoms, sore throat, sinusitis
- Muscle pain
- Weight gain
- Gas, flatulence
- Fractures (in women)
Stories from Readers:
Bill relates the following experience:
“I started taking Actos in early 2007 for my type 2 diabetes. At the time I was 43, a non-smoker and only about 15 pounds overweight. About a year and a half later I started urinating blood which led to tests, antibiotics, and eventually a diagnosis of bladder cancer.
“I underwent two surgeries to remove tumors, spent 2 weeks in the hospital due to complications from the surgeries and went through several months of liquid chemo treatments. At the time of diagnosis my urologist was unsure what caused the cancer. He said I was younger than most people diagnosed, and had no known risk factors.”
Mike in Roswell, GA says:
“I took Actos for 4 years. I developed cancer in the right kidney. Related? I don’t know but I sure discontinued Actos after they surgically removed my kidney. I wonder if any other cancers than bladder have been associated with Actos or it’s cousin Avandia, which I also took.”
A Grandma in Central Florida says:
“I took this medicine for about a year and did not like the way I felt on it. I also developed persistent swollen ankles. I mentioned the way I felt to a kidney specialist who was treating me for a temporary problem at the time, and he immediately took me off the drug and stated that he didn’t like this particular medicine.”
Cara in Coupeville has some harsh words for the FDA:
“I took Actos for a decade, until ten years ago. I asked three doctors and a hospital medical staff doctor to let me stop that drug. I had gained a huge amount of weight and my legs had swelled. They just said that’s what happens to diabetics. I would lose my legs.
“I wasn’t buying it. I knew it was the drug Actos causing my problems. My legs had huge blisters on them that seeped. Even gangrene set in.
“At that point, a friend recommended a naturopathic doctor [ND]. He investigated the drug, called me and said it’s a horrible drug. He took me off of it, gave me an antibiotic, and three weeks later my legs were normal and my weight had started coming down. I lost 140 pounds.
“The FDA is in the hands of the drug companies. They don’t care. Listen to your body. Sometimes you do know what’s best. I still go to that ND and still have my legs. Actos should be removed the market. The FDA doesn’t have the guts to do it.”
Share your own experience with diabetes drugs in the comment section below. Consider our Guide to Managing Diabetes for more information on other diabetes medications as well as non-drug approaches for helping to keep blood sugar under control. We have a whole chapter on this topic in our book Best Choices from The People’s Pharmacy.
