Thursday, June 28, 2012

Type 2 Diabetes Drug Warning

Type 2 Diabetes Drug Warnings
Thiazolidinediones (TZDs) are the dysfunctional family of type 2 diabetes medications. There are three drugs in the TZD family:  Rezulin, Avandia and the newest member, Actos. Each of these drugs promises to lower blood sugar but poses serious health threats.
By the time the Food and Drug Administration(FDA) started the damage-control process by adding a warning to these drug labels, millions had already filled prescriptions of these harmful medications.
Takeda Pharmaceuticals began marketing a new oral diabetes medication known as Actos (pioglitazone) in 1999. Actos works by increasing the body's sensitivity to insulin, usually lowering blood sugar by 1 A1C. However, the side effects can be mighty tough to swallow.
The severe side effects of Actos include impaired vision, weakened bones, heart problems and bladder cancer. In fact, long-term use of Actos increases the risk of bladder cancer by 83 percent.  
In 2011, France and Germany reacted to studies that showed a link between Actos and bladder cancer by banning the drug altogether.
The FDA began a safety review of Actos in 2010, while the drug was still increasing in popularity in the United States as the 10th most prescribed drug.  The FDA's response to the safety review was mediocre, as it merely added a warning label to the medication.
The warning does not describe the full extent of a bladder cancer diagnosis that begins with users noticing physical symptoms like pain while urinating or blood in urine, and may progress to the point of requiring multiple surgeries, chemotherapy, radiation and bladder removal.
Bladder cancer affects the lives of thousands, resulting in death for around 15,000 Americans each year. And Actos takes people one step closer to this diagnosis — especially for those who use the drug for a longer period of time.
The FDA reacted to the dangers of Avandia, another thiazolidinedione, by severely restricting access to the drug.
GlaxoSmithKline began marketing Avandia (rosiglitazone) in 1999, the same year Actos came out. In 2006, Avandia sales were as high as $3.2 billion. Meanwhile, thousands of users were experiencing heart attacks and heart failure. GlaxoSmithKline has faced more than 20,000 Avandia lawsuits relating to heart problems.
The third drug in this family, Rezulin (troglitazone), was removed from the market in 2000 after causing liver toxicity leading to liver failure and death.
The FDA had rushed the approval process for the drug and put it on the market in 1997. Following reports of adverse reactions, the FDA increased the warning label and required liver tests for patients using Rezulin.
After three years of Rezulin use and 90 cases of liver failure (with 63 fatalities), the FDA finally ordered the drug to be taken off the market.  
Whether it’s a recall or a warning label, any type 2 diabetes medications should be approached with caution.

Alanna Ritchie writes about prescription drugs and medical devices for

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