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Background Information about Actos and Bladder Cancer


In 1999 with Actos received FDA approval to treat type II diabetes. Before getting approval for Actos, Takeda knew that it would cause casastrophic side effects, including bladder cancer. Animal studies showed a signal for bladder cancer risk. Takeda knew that they should have studied the bladder cancer risk further. Bladder cancer evidence in human studies became available in the early 2000s. From the date of approval, Takeda sold Actos without adequate warnings of its side effects.

For 10 years Takeda failed to study and properly warn of the risk of bladder cancer. On June 7, 2011, a French study showed that use of Actos for more than one year increases the risk of bladder cancer. On June 9, 2011, the European medicine agency suspended the use of Actos because of the bladder cancer risk. On June 10, 2011, Germany suspended the years of Actos. On June 5, 2011, the FDA warned that Actos causes bladder cancer. On June 15, 2011, the FDA advised that people with bladder cancer should stop using Actos.


The bladder is a hollow organ in the lower abdomen. It stores liquid waste made by the kidneys. Your bladder is part of the urinary track. Urine passes from each kidney into the bladder through a long tube called a ureter. Urine leaves the bladder through a shorter tube called the urethra. The wall of the bladder has three layers of tissue: the inner layer of tissue which is also called the lining. As your bladder fills up with urine, the transitional cells on the surface stretch. When you empty the bladder, these sales shrink. The middle layer is muscle tissue. When you empty the bladder, the muscle layer in the bladder wall squeezes the urine out of the body. The outer layer covers the bladder. It has fat, fibrous tissue, and blood vessels.

Bladder cancer may cause these common symptoms: finding blood in your urine; feeling an urgent need to empty your bladder; having to empty your bladder more often than you used to; feeling the need to empty your bladder without results; needing to strain when you empty your bladder; and feeling pain when you empty your bladder. These symptoms may be caused by bladder cancer, or other health problems such as an infection. If you experiencing symptoms, especially if you are taking Actos, you should contact your doctor immediately. You will want to be treated as early as possible.

If you have symptoms that suggest bladder cancer, your doctor will try to diagnose your problem. You may have a physical exam and the following tests: you’re in tests (wear a lab tests your urine for blood and cancer cells); cytoscopy (where a doctor uses a thin tube to look in your bladder); and a biopsy (where a pathologist examines your bladder tissues under a microscope).

Bladder cancer is cancer is that forms in the tissues of the bladder (the organ that stores urine). Most bladder cancers are transitional cell carcinomas (cancer that begins in cells that normally make up the inner lining of the bladder). Other types of squamous cell carcinoma (cancer that begins in sin, flat cells) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids). The cells that form squamous cell carcinoma and adenocarcinoma developed in the inner lining of the bladder as a result of chronic irritation and inflammation.

If cancer cells are found in the tissue sample from the bladder, the pathologist studies the sample under a microscope to learn that grade of the tumor. The grade tells how much the tumor differs from normal bladder tissue. It may suggest how fast the tumor will grow. Tumors with higher grades tend to grow faster than tumors with the lower grades. They are also more likely to spread. Doctors use tumor grade with other factors to suggest treatment.

Cancer begins in cells, the building blocks that make up tissues. Tissues make up the bladder and the other organs of the body. Normal cells grow and divide to form new cells as the body needs them. When normal cells grow old or get damaged, they die, and new cells take their place. Sometimes, this process goes awry. New cells form when the body doesn’t need them, and old or damaged cells don’t die as they should. The buildup of extra cells often becomes a mass of tissue called a growth or tumor. Tumor is in the bladder can be benign (not cancer) or malignant (cancer).

Benign tumors are not as harmful as malignant tumors. Benign tumors: Is usually not a threat to life; can be treated or removed and usually don’t grow back; don’t invade tissues around them; and don’t spread to other parts of the body. Malignant growths: may be a threat to life; usually can be removed but can’t grow back; can invade and damage nearby tissues and organs; and can spread to other parts of the body. Bladder cancer can spread by breaking away from the original tumor. They can spread through the blood vessels to the liver, lungs and bones. Bladder cancer cells may also attach to other tissues and growth to form new tumors that may damage those tissues. The bladder cancer cells can also spread through lymph vessels to lymph nodes.

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