Takeda’s best-selling diabetes medication Actos has been banned in France and Germany amidst new information tying the drug to a high risk of bladder cancer.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
Update: FDA Confirms Actos Bladder Cancer Link
December 15, 2016 – FDA has updated its review of Actos, confirming that use of the drug may increase the risk of bladder cancer. While Actos labels already contain a warning about the bladder cancer risk, the agency is once again updating the labeling to describe the additional studies it has reviewed.
What’s the problem?
The French Medicines Agency made the decision to ban Actos and Competact – a similar drug that combines Actos and metformin – after a recent study confirmed that the medications increased the risk of bladder cancer side effects. After reviewing the findings of the French report, which analyzed Actos and Competact over a period of three years, German health officials quickly followed suit and pulled the drugs in their country as well.
Here in the U.S., the Food & Drug Administration (FDA) has been reviewing Actos closely over the past year after reports that users who took the medication for a period of two years or more were at an increased risk of developing bladder cancer. Up until recently, Actos has been considered safer than the controversial drug Avandia, which is in the same class of medications.
What is Actos?
Actos (generic: pioglitazone) is an oral diabetes medication that is designed to help control blood sugar levels in type 2 diabetics. Actos works to control blood sugar levels in your body by reducing insulin resistance – a condition in which the body’s cells don’t respond to the insulin that allows them to turn blood sugar into energy. While not approved to treat lipid disorders, Actos may have a positive effect on HDL (good) cholesterol and triglycerides (blood fats) without changing LDL (bad) cholesterol or total cholesterol.
Actos Bladder Cancer
Bladder cancer is a cancerous tumor in the bladder, an organ in the center of the lower abdomen that holds urine. The disease usually starts from cells lining the bladder called transitional cells. These tumors are classified by the way they grow – papillary tumors have a wart-like appearance and are attached to a stalk, while nonpapillary tumors are less common but more invasive and typically have a worse outcome. Signs and symptoms of Actos-induced breast cancer include:
- blood or blood clots in the urine
- pain during urination (dysuria)
- urinating small amounts frequently
- frequent urinary tract infections
Symptoms that may be indicative of more advanced bladder cancer include:
- lower back pain
- swelling in the lower legs
- a growth in the pelvis near the bladder (pelvic mass)
- weight loss
- bone pain or pain in the rectal, anal or pelvic area
Side Effects of Actos
In addition to being associated with bladder cancer, Actos has also been linked to the following side effects:
- congestive heart failure (CHF)
- heart attack
- liver problems
The link between Actos and these side effects is strong enough that in 2007 the FDA increased the warnings on the drug concerning congestive heart failure.
Actos Heart Failure
According to a September 2007 study, Actos and Avandia were found to increase the risk of heart failure. The research concluded that heart failure risks are greatest for patients with a history of heart disease and heart failure, but less for those who had no heart problems. Overall, the relative risk was 72 percent higher. The study, which was published in the journal Lancet, came just four months after a similar study found that Avandia increased the risk of death by 64 percent and the risk of heart attack by 43 percent. Both Actos and Avandia carry ‘black box’ warnings – the strictest allowed by law – on their labeling that they may cause or worsen congestive heart failure, a chronic condition in which the heart fails to pump efficiently. Signs and symptoms of congestive heart failure include:
- swelling (edema) of the ankles, legs or abdomen
- shortness of breath
- inability to sleep unless in a sitting position
- increased urination
- abdominal pain
- decreased appetite
If you are taking Actos
Do not take Actos if you:
- are allergic to pioglitazone
- have severe heart failure or heart disease
- have diabetic ketoacidosis
- have a history of stroke or liver disease
If you are currently taking Actos, monitor your blood sugar levels closely. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol or are experiencing high levels of stress. Symptoms of hypoglycemia include:
- trouble concentrating
Be sure to always carry hard candy or glucose tablets with you in case you have low blood sugar. Be sure your friends and family know how to help you in case you go into diabetic shock.
Additional Resources & Information
- Actos Bladder Cancer Lawsuit Filed by Blue Cross
- Judge Warns Takeda Over Bad Behavior in Actos Bladder Cancer Litigation
- Jury Awards $9 Billion in Actos Bladder Cancer Lawsuit
Ohio Man Blames Actos for Bladder Cancer Diagnosis
July 15, 2015 – A man from Orange, Ohio, filed a lawsuit against Takeda Pharmaceuticals today alleging that his use of Actos for type 2 diabetes caused him to develop bladder cancer. Plaintiff William Harstein is seeking compensation for medical expenses, pain and suffering, mental anguish and expenses related to the elevated cost of living incurred as a result of his cancer diagnosis. Click here to learn more.
Do I have an Actos Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. Our lawyers are handling individual litigation nationwide and currently accepting new bladder cancer cases in all 50 states.