Actos side effects for this popular diabetes drug now include bladder cancer. Actually, this is not news to researchers, since testing on laboratory animals long ago showed an increase in bladder tumors. These results showed up in male rats who were exposed to Actos at the same equivalent dosages that are prescribed to humans. The double whammy is that Actos also has the same level of cardiovascular risks as another drug in the same chemical family, the now controversial drug Avandia. Read more on what you should know. Diabetics have better options than these.

Nothing Really New

The latest headline about Actos (generic name, pioglitazone) is that the Japanese manufacturer, Takeda, under orders from the FDA, has begun a long-term study of nearly 200,000 people in California to determine the cancer risk of Actos.

The interesting thing is that this risk was already observed in lab animals. Furthermore, bladder cancer has been reported often enough in people that the new study is reactive rather than proactive regarding this risk. Indeed, the incidence of cancer rises with increasing dosage and duration of use beyond the median (24 months). This is a drug whose annual sales are 4.5 billion dollars. What do you think the FDA will do? The first comment by the FDA is probably predictive. The agency already released a statement that the increased incidence of bladder cancer at 24 months is statistically insignificant. Don’t you feel better now?

Basics of Actos

This is quoted from Wikipedia on Actos:

Pioglitazone is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action. Pioglitazone is marketed as trademarks Actos in the USA and UK, Glustin in Europe,”Glizone” and “Pioz” in India by Zydus CND and USV respectively and Zactos in Mexico by Takeda Pharmaceuticals. Actos was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion. [Note that this figure is about half of the latest annual report.]

Listed Side Effects

A press release by GlaxoSmithKline in February 2007 noted that there is a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide. The information was based on data from the ADOPT trial. Following release of this statement, Takeda also admitted that pioglitazone has similar implications for female patients.

The risk of hypoglycemia is low in the absence of other drugs that lower blood glucose.

Pioglitazone can cause fluid retention and peripheral edema. As a result, it may precipitate congestive heart failure (which worsens with fluid overload in those at risk). It may cause anemia. Mild weight gain is common due to increase in subcutaneous adipose tissue. In studies, patients on pioglitazone had an increased proportion of upper respiratory tract infection, sinusitis, headache, myalgia and tooth problems.

On July 30, 2007 an Advisory Committee of the Food and Drug Administration concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of “myocardial ischemic events” when compared to placebo, but when compared to other diabetes drugs, there was no increased risk. Pioglitazone is currently being reviewed. A meta-analysis released subsequently showed that pioglitazone reduced the number of ischemic cardiac events rather than increase the risk, but increases CHF. The PERISCOPE study compared pioglitazone with glimepiride in diabetics; atherosclerotic plaque volume was measured and followed over time. Glimepiride therapy had highly significant progression of plaque volume over time of 0.73 percent. In comparison, pioglitazone had a -0.16 percent regression in plaque volume. This is the first study to show that diabetic therapy slowed progression of atherosclerosis. Therapy with pioglitazone raised HDL, and lowered triglyceride and hsCRP; these are all beneficial effects on risk factors for coronary artery disease, however to date, no oral anti-diabetic drug has been shown to reduce the risk of cardiovascular complications. Chronic administration of the drug has led to occasional instances of cholestatic hepatitis, reversible upon drug discontinuation.

Preliminary data from a 10-year epidemiological study from Takeda Pharmaceutical Company indicated a possible link between pioglitazone and bladder cancer. The findings prompted the FDA to order safety reviews for the drug in September 2010.

Not So Scary Alternatives

Diabetes is a spectrum disorder. Depending on where you are along the spectrum, from incipient or pre-diabetes to full-blown pancreatic failure, you have dietary and supplement alternatives that are much more effective and much better for your health than any drug. You have many, many options.

Actos side effects news,

Dr. D

Related articles by Zemanta

• UPDATE 2-US FDA reviewing safety of Actos diabetes drug (reuters.com)
• FDA reviewing cancer risk with diabetes pill Actos (seattletimes.nwsource.com)
• Diabetes Drug Actos (pioglitazone) Review Initiated To Determine Possible Bladder Cancer Link (medicalnewstoday.com)
• Why The New Drugs Cause Such Terrible Side Effects (diabetesupdate.blogspot.com)
• Takeda Responds to FDA Advisory Committee Recommendation (newswire.ca)