Actos

What Is Actos®?

Actos® is an orally ingested medication that has been prescribed to treat type 2 diabetes. Actos® was introduced into the market in 1999 when it was approved by the U.S. Food and Drug Administration. Actos® is manufactured by Takeda Pharmaceutical Company Ltd., and co-manufactured in the United States by Eli Lilly Pharmaceuticals.

What Is Type 2 Diabetes?

Type 2 diabetes is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. Type 2 diabetes is also known as diabetes mellitus type 2, and was formerly known as non-insulin-dependent diabetes mellitus or adult-onset diabetes.

What Was the FDA Safety Announcement?

In June 2011, the FDA issued a safety announcement “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. Information about the risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the rise of bladder cancer.”

The FDA announcement stated to patients:

• There may be an increased chance of having bladder cancer when you take Actos®.
• You should not take Actos® if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with Actos®. It explains the risks associated with the use of Actos®.
• Talk to your healthcare professional if you have questions or concerns about Actos®.
• Report side effects from the use of Actos® medicines to the FDA MedWatch program.

The FDA announcement further stated to healthcare providers:

• Do not use Actos® in 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 Urinary Bladder Cancer?

Bladder cancer includes tumors that are any of several types of malignant growths of the urinary bladder. This is a disease in which abnormal cells multiply without control in the bladder. Bladder cancer characteristically causes blood in the urine, which cannot always be seen with the naked eye.

What Are The Symptoms Associated With Bladder Cancer?

Symptoms of bladder cancer include:

• blood or red color in urine
• urgent need to urinate
• pain while urinating
• pain in back or lower abdomen

How Is Bladder Cancer Diagnosed?

Many patients with a history, signs, and symptoms suspicious for bladder cancer are referred to a urologist or other physician trained in cystoscopy, a procedure that uses a flexible tube bearing a camera and various instruments that is introduced into the bladder through the urethra.

The most reliable procedure for diagnosing bladder cancer is biopsy obtained during cystoscopy. Sometimes bladder cancer is an incidental finding during cystoscopy. Urine cytology can be obtained in voided urine or at the time of the cystoscopy (“bladder washing”). Cytology is very specific such that a positive result is highly indicative of bladder cancer.

A diagnosis of bladder cancer can made with a CysviewTM guided fluorescence cystoscopy, as an adjunct to conventional white-light cystoscopy. This procedure improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone. Cysview cystoscopy detects more cancer and reduce recurrency.

How Is Bladder Cancer Treated?

The treatment of bladder cancer depends on how deep the tumor invades into the bladder wall. Surface tumors (those not entering the muscle layer) can be “shaved off” using an electrocautery device attached to a cystoscope. Immunotherapy in the form of BCG instillation is also used to treat and prevent the recurrence of surface tumors.

BCG immunotherapy is effective in up to 2/3 of the cases at this stage. Instillations of chemotherapy, such as valrubicin(Valstar) into the bladder can also be used to treat BCG-refractory CIS disease when cystectomy is not an option. Urocidin is phase III trials for this.

A combination of radiation and chemotherapy can also be used to treat invasive disease. It has not yet been determined how the effectiveness of this form of treatment compares to that of radical ablative surgery.

How Is Urinary Bladder Cancer Testing And Treatment Being Paid For, And How SLChapman LLC Can Help?

If you have been prescribed Actos® and are currently experiencing symptoms of urinary bladder cancer, then you will be responsible for all costs for testing and/or treatment. However, you may have a strong legal position that warrants additional analysis. At SLChapman LLC, we understand that the damages you have suffered or will be caused to endure as a result of taking Actos®, and we will work to obtain the maximum award provided for under the law. If you have been prescribed Actos® and are currently experiencing symptoms of urinary bladder cancer, then you can get help by contacting the experienced lawyers at SLChapman LLC for a free initial consultation. E-mail SLChapman LLC at actos@slchapman.com, or call (800) 851-5523.today.