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Actos and Bladder Cancer: A Case of Cause and Effect

Type 2 diabetes, which is also called adult-onset diabetes and non-insulin-dependent diabetes, is a serious illness suffered by many individuals around the globe. This persistent disease influences the body’s behavior in processing sugar/glucose, which is the body’s main source of energy. There are ways to prevent this type of diabetes; however, if unchecked and allowed to develop, it would result to lifetime suffering.

Though anyone can be susceptible to Type 2 diabetes, those who are 45 years old or above and most often inactive, have low HDL cholesterol or a high triglycerides level, hypertensive, overweight and have been diagnosed with pre-diabetes or gestational diabetes, are more prone to developing it.

A person will start suffering from the dreaded diabetes when he/she begins to have high blood sugar. This happens when his/her pancreas (the gland near our stomach which secretes the hormone insulin and controls the amount of sugar in the bloodstream) stops to produce, or begins to produce, very little insulin or when it no longer responds to insulin. This sugar or glucose comes from all the food and beverages a person consumes; it is also the cell’s source of energy – the energy the body needs to be able to perform daily activities normally.

In 1999 the oral diabetes medicine Actos (also called Pioglitazone), from Takeda Pharmaceuticals, was approved by the US Food and Drug Administration for market release. The drug was intended to help Type 2 diabetics control their blood sugar level by increasing their sensitivity to insulin. Actos also helped decrease the amount of glucose that the liver releases and it was claimed safe even if taken without food.

It should be noted, though, that Actos is not a cure to Type 2 diabetes, to which there is no known cure; it only helps the body to manage glucose level and absorption of insulin. In 2008 Actos became the 10th most prescribed drug in the US. Its efficacy was, likewise, recognized in a number of European countries, like France and Germany.

Studies that showed Actos’ effect in increasing the risk of bladder cancer surfaced in 2010, though, and despite the fact that an earlier study, conducted in 2005, already arrived at this same conclusion, this finding was never brought to the attention of the FDA. Cases of adverse effects and deaths due to Actos piled one on top of another. Despite this, Takeda kept denying that Actos increased the risk in the development of bladder cancer. Besides bladder cancer, the drug was also found to cause severe, permanent damage to vital internal organs.

As early as 2011 at least 10,000 lawsuits were filed against Actos’ manufacturer Takeda. The company’s continuous denial of the adverse effects of Actos, despite knowledge of it and the obvious evidences render it much more liable as it openly violated patients’ trust.

Symptoms of bladder cancer include: presence of blood in urine, constant urgency and straining to empty bladder, frequent urination and feeling of pain when urinating.

What is the Basis for a Byetta Lawsuit?

Diabetic patients prescribed with Byetta prior to 2007 and had since developed acute pancreatitis may be able to receive personal injury compensation from Amylin.

Byetta is a synthetic prescriptive drug used to control blood sugar levels of people suffering from type 2 diabetes or diabetes mellitus type 2. It is manufactured by Amylin Pharmaceuticals and distributed in the US by Eli Lilly & Co. The twice-daily injectable Byetta and its once-weekly counterpart Bydureon, generic name exenatide, have been found to be efficacious in reducing the glucose levels in blood by mimicking the effects of incretins (incretin mimetic), a hormone released by the intestine in the blood when food is introduced, which in turn increases insulin production of the pancreas. Exenatide also reduces the appetite, which helps in weight loss. Exenatide has been approved by the Food and Drug Administration since 2005.

There are side effects associated with Exenatide, including nausea, hypoglycemia, excess sweating, headache and gastrointestinal distress. However, it is the unfortunate effect on the pancreas that has brought attention to Exenatide. The direct action of Exenatide is on the pancreas, which dictates the release of glucose-processing insulin in the blood. In some cases, patients who have been prescribed with Byetta developed acute pancreatitis, the sudden inflammation of the pancreas that can lead to serious health complications and death.

Because of this side effect, the FDA decreed in 2007 that Byetta labels should include a warning about the risk of developing pancreatitis even though the association has yet to be definitively established. Nevertheless, if you or someone you know is a Byetta user prior to 2007 and developed (or died from) acute pancreatitis, it is possible that a claim for personal injury may be successful. A lawyer conversant with the laws applicable to a Byetta lawsuit should be consulted to assess the situation. It is noteworthy that in some studies, exenatide use increases the risk of developing problems with the thyroid in rats, including cancer.