Actos: Bladder Cancer Risks
In September 2010, the FDA announced it was reviewing data from an ongoing 10-year study of Actos (pioglitazone) and the risk of bladder cancer.
FDA completed its review of five-year results, which showed that although there was no overall increased risk of bladder cancer from Actos, an increased risk was found among patients who had used Actos the longest (for more than 2 years) and at the highest doses.
In June 2011, the European Medicines Agency was informed by the French Medicines Agency of its decision to suspend the use of Actos-containing medicines in France, while awaiting the outcome of the ongoing European review on the risks and benefits of some anti-diabetic medicines.
On June 15 2011 the FDA informed the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Information about this risk would be added to the Warnings and Precautions section of the label for medicines containing Actos. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
In one European country (France), Actos sales are suspended until further review of the risks and benefits of this Type 2 diabetes drug. In the United States, it’s business as usual and more warnings will be added to the label.
FDA Issues Warning on Actos for Bladder Cancer
Another day, another FDA warning… is anyone heeding the warning that Actos may cause bladder cancer?
Actos is used along with diet and exercise to improve control of blood sugar in adults who have type 2 diabetes mellitus.
On June 15, 2011, the FDA distributed safety information based on their review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone (Actos) use, an increased risk of bladder cancer was noted among patients with the longest exposure to the drug, and in those exposed to the highest cumulative dose of pioglitazone.
The FDA is also aware of a recent study conducted in France which suggests an increased risk of bladder cancer with pioglitazone (Actos). Based on the results of this study, France has suspended the use of Actos and Germany has recommended to not prescribing Actos in new patients.
But what does the U.S. FDA do?
The FDA issues a warning on Actos for bladder cancer.
From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.
If you or a family member has been prescribed Actos or an Actos related drug and you have been diagnosed with bladder cancer – please contact Monheit Law to find out what legal options are available to you. Filing an Actos claim may be prudent because it will help pay your medical bills and fill in the blanks if you are unable to work or provide for your family.
When Did Actos Come Off the Market?
In the United States, Actos did not come off the market. Actos is still for sale and the makers of Actos are still selling millions of prescriptions. It’s mega-business as usual for the Takeda Pharmaceutical Company.
According to a New York Times blog written in 2010: “Last year, Avandia had $521 million in sales in the United States, compared to market leader Actos with $3.4 billion, according to data provided Monday by the industry tracking firm IMS Health.
Five years ago, they were nearly even in sales, with $1.8 billion for Avandia, made by British-based GlaxoSmithKline, and $2.1 billion for Actos, from the Japanese drug maker Takeda Pharmaceutical. Avandia loses patent protection in 2012, Actos in 2011.
Recent studies have indicated Actos is safer than Avandia, which has been linked to heart problems.”
The blog post was written prior to the June 2011 FDA warning and August 2011 label update regarding Actos may possibly cause bladder cancer in patients who have been taking the type 2 diabetes drug for more than a year.
Actos did come off the market in France and Actos is no longer being prescribed to new type 2 diabetes patients in Germany. But as far as the United States – Actos is still for sale. Corporate pharmaceutical greed trumps consumer safety.
If you or a family member has been diagnosed with bladder cancer after being prescribed Actos for more than a year – you may have legal options regarding an Actos lawsuit. Please contact Monheit Law to get some answers.
Types of Bladder Cancer
According to statistics, in the United States, bladder cancer is estimated to occur in 20 per of every 100,000 people per year and is thought to be a higher occurrence among diabetics.
There are three different types of bladder cancer that begin in cells in the lining of the bladder. These cancers are named for the type of cells that become malignant cancerous:
Transitional cell carcinoma begins in cells in the innermost tissue layer of the bladder. These cells are able to stretch when the bladder is full and shrink when empty. Most bladder cancers (around 90 percent) begin in the transitional cells.
Squamous cell carcinoma begins in thin flat cells that may form in the bladder after a long bout of infection or irritation.
Adenocarcinoma begins in the glandular cells that form in the bladder after long-term irritation and inflammation.
There are different stages for bladder cancer:
Stage 0 (zero) is the earliest and least serious stage. The cancer is growing in the inner lining layer of the bladder only. Bladder cancer in the early stages is frequently curable.
In Stage I, the cancer has grown into the layer of connective tissue under the lining layer of the bladder but has not reached the layer of muscle in the bladder wall. The cancer has not spread to the lymph nodes.
For Stage II, the cancer has grown into the thick muscle layer of the bladder wall, but it has not passed completely through the muscle to reach the layer of fatty tissue that surrounds the bladder. At this point the cancer has not spread to lymph nodes or to distant sites.
At Stage III, the cancer has grown completely through the bladder into the layer of fatty tissue surrounding the bladder. It may have also spread into the prostate, uterus, or vagina but not the lymph nodes.
For Stage IV, the cancer has grown through the bladder wall and into the pelvic or abdominal wall. Stage IV is the most advanced and the most serious.
Is there a connection between your type 2 diabetes medication and being diagnosed with bladder cancer? If you don’t know – ask Monheit Law to uncover the facts and find out what your legal options are.
Frequently Asked Questions:
Actos Lawsuit, Bladder Cancer Treatment
Do I have an Actos lawsuit? How can I find out?
You might be entitled to an Actos lawsuit if you were prescribed Actos for more than one year and have been diagnosed with bladder cancer. You won’t know your eligibility until you inquire.
People often wonder what they have to gain by filing an Actos lawsuit. Treating bladder cancer, if it’s treatable, will require create a mountain of medical expenses, costly medications and specialists, time lost from work and activities, and perhaps a diminished quality of life. Why? All because you were prescribed an unsafe drug in order to manage your Type 2 diabetes. It’s just not right and a settlement can help.
How can I afford an Actos lawsuit?
Many people fear going to a lawyer because they think the costs will be prohibitive. If you agree to hire Monheit Law and they agree to be retained by you, they take your Actos case on a contingency fee basis. What that means that you have no upfront costs or out-of-pocket expenses. Monheit Law gets paid when they win your case. So yes, you can afford an Actos lawsuit.
Who makes Actos?
Takeda Pharmaceutical Company Limited the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 19,000 employees worldwide and achieved $15.7 billion USD in revenue during the 2008 fiscal year. Takeda focuses on metabolic disorders, gastroenterology, neurology, inflammation, as well as oncology through its independent subsidiary, Millennium: The Takeda Oncology Company. Its headquarters is located in Osaka and it has an office in Tokyo.
What should healthcare professionals know before prescribing Actos?
- Do not prescribe Actos to patients with active bladder cancer.
- Use Actos with caution in patients with a prior history of bladder cancer. The benefits of glycemic control versus unknown risks for cancer recurrence with Actos should be considered in patients with a prior history of bladder cancer.
- Counsel patients to report any signs or symptoms of blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.
- Encourage patients to read the Medication Guide they get with their Actos medicine.
- Report adverse events involving Actos medicines to the FDA MedWatch program.
What is the treatment for bladder cancer?
There are numerous treatments for bladder cancer which are best discussed with your doctors and your family. Treatments will depend at what stage your bladder cancer is, your medical insurance, your general health, and other factors. Some of the options are surgery, immunotherapy, chemotherapy, and radiation therapy.
What other life threatening side effects does Actos have?
The Actos family of drugs is not for everyone. Other Actos drugs include Actoplus met, Actoplus met XR, and duetact. Type 2 diabetic medications may cause or worsen heart failure. Heart failure means your heart does not sufficiently pump blood. Patients with symptoms of heart failure should not start taking Actos.
Does Actos Cause Bladder Cancer?
On June 15, 2011 the FDA informed the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer.
In June 2011, the European Medicines Agency (EMA) was informed by the French Medicines Agency of its decision to suspend the use of pioglitazone-containing medicines (Actos) in France, while awaiting the outcome of the ongoing European review on the benefits and risks of prescription drugs for diabetics.
Prompted by an increased number of spontaneous reports of bladder cancer, the EMA considered that the accumulated evidence provided also by preclinical studies, epidemiological data and a placebo controlled clinical trial, represents a clinically relevant signal which requires further evaluation.
This decision by the French authority follows receipt of results of a retrospective cohort study carried out in France which became available on this date. These results appear to suggest an increased risk of bladder cancer with Actos.
Also in June 2011 results were published regarding the association of Actos use and bladder cancer through the publication, Diabetes Care.
Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs, with 31 concerning Actos. When reporting by age 10 cases occurred during clinical studies. Do yousuffer from bladder cancer after taking Actos?
On June 15, 2011 the FDA informed the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer.
Actos Drug May Raise Risk of Bladder Cancer
Bladder cancer is a cancerous tumor in the bladder. Should the diabetes drug Actos raise the risk for bladder cancer?
In 2003, the FDA requested that Takeda, the Actos maker, conduct a safety study to assess whether therapy with this type 2 diabetes drug increases the risk of bladder cancer. At the request of the FDA, the study was planned to be conducted over 10 years. In April 2011 the authors who drafted the initial protocol and were subsequently reviewed by the FDA, revised the Actos safety study accordingly and published the results of the planned midpoint interim analysis.
When the association between bladder cancer incidence and increasing levels of Actos was revealed, exposure to the risk of bladder cancerslightly increased with increasing dose and duration of Actos use. What is wrong with this picture?
Bladder cancer symptoms include – urine frequency, urine urgency, blood in the urine, painful urination, stomach pain, urinary incontinence, anemia and fatigue, and weight loss. These symptoms can also be the signs for other medical conditions.
Should bladder cancer be a life-threatening Actos side effect from an already life-threatening condition like type 2 diabetes?
First, let’s determine some of the causes of bladder cancer:
- Genetic causes;
- Smoking cigarettes and other tobacco products;
- Radiation therapy;
- Drinking insufficient amounts of water;
- Using the chemotherapy drug Cytoxan on a long-term basis which can irritate the bladder and increase the risk of bladder cancer;
- Eating excessive amounts of grilled meat and fat;
- Occupational hazards for bus drivers, rubber workers, hairdressers, farm workers, leather workers, blacksmiths, gardeners/landscapers, mechanics;
- Toxic substance exposure dyes, paint, pesticides, mineral oils, leather, dust, PAHs, diesel engine exhaust, asbestos, creosote, combustion, chlorinated solvents;
- Actos, a type 2 diabetes drug, has also been associated as a cause for bladder cancer.
Type 2 diabetes is a growing problem. From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing (Actos) product from outpatient retail pharmacies.
Bladder cancer is on the rise in the United States. According to the National Cancer Institute, there are an estimated 69,250 new cases and 14,990 deaths from bladder cancer in the U.S. during 2011.
If you have bladder cancer and have been taking Actos for more than a year, then you should consider talking to Monheit Law to determine whether or not Actos caused bladder cancer.
It has been 8 months since the June 2011 FDA warning on Actos and many patients and their loved ones still have questions such as is Actos still on market and is Actos safe to use?
The answer to the first question is yes. As of February 2012, Actos remains on the market in the United States.
The answer to the second question is more complicated. The FDA has warned that there is a possibility that the Actos drug causes bladder cancer. The FDA is most concerned about the potential development of the disease when Actos is used for more than one year and the patient has, or has had, bladder cancer. However, that does not mean that the risk is always confined to people who use Actos long term and have a history of bladder cancer.