Generic Actos, What You Should Know

Aug 19 2012 - 1:55pm
Generic Actos, what you should know
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The Food and Drug Administration (FDA) has approved the first generic formulation of Actos (pioglitazone hydrochloride) for treatment of type 2 diabetes, which can be good news for people with diabetes who need to take oral antidiabetes drugs. Since Actos is in the news, it's a good time to review what you should know about this drug.

What do you know about Actos?

Actos was developed to be used along with a sensible diet and regular exercise, as well as other medications if needed, to manage blood sugar (glucose) levels in people who have type 2 diabetes. Pioglitazone is one of three thiazolidinediones that has been introduced to the market for type 2 diabetes treatment. The other two drugs are:

  • Rosiglitazone (Avandia), which is still available in the United States on a limited basis only because of potential cardiovascular risks. It has been taken off the market in Europe.
  • Troglitazone (Rezulin), which was withdrawn from the market because its use increased the risk of hepatitis

Pioglitazone works by enhancing the sensitivity of the body to insulin, the hormone necessary for controlling blood sugar levels. If too much sugar stays in the bloodstream and is not transported into the cells by insulin, individuals are highly susceptible to develop serious health problems such as kidney damage, neuropathy, vision problems, and an increased risk of heart disease and stroke.

Actos, and now the generic drug available from Mylan Pharmaceuticals in 15 milligram, 30 mg, and 45 mg doses, provide patients with equal potency and quality. The difference between Actos and the generic brand is a lower cost for the latter product.

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If you currently take pioglitazone or may in the future, you should be aware of its possible side effects. Based on the results of clinical trials, the most common side effects are upper respiratory tract infection, headache, muscle pain, sore throat, and sinus infection.

Of greater concern are the Boxed Warning concerning heart failure, the label warning about bladder cancer, and a risk of fractures. Let's look at each of these separately.

Problems associated with pioglitazone
Before taking pioglitazone, you also should be aware of the following possible problems--and a potential benefit.

  • Heart failure. The Boxed Warning on pioglitazone stresses that the drug may cause or worsen congestive heart failure in some individuals, and that the drug is not recommended for anyone who has symptomatic heart failure. Symptoms of heart failure include edema (swelling of the hands, feet, ankles, arms, and/or lower legs), shortness of breath, pain or swelling in the stomach, confusion, wheezing or dry cough, increased tiredness, and rapid, excessive weight gain.
  • Bladder cancer. A series of studies over the past few years have noted an increased risk of bladder cancer associated with the use of thiazolidinediones, including Actos. Results of the most recent research showed a two- to threefold increased risk of bladder cancer among individuals who used Actos for five years or longer.
  • Fractures. Results of one large study indicate an increased risk of fracture among women who take Actos. In the Prospective Pioglitazone Clinical Trial in Macrovascular Events (macrovascular events include stroke, heart disease, vascular disease), 5,238 patients who had type 2 diabetes and a history of macrovascular diseases were given either Actos or placebo along with standard care. The incidence of fractures among women was 5.1% for those who took Actos compared with 2.5% among those who took placebo. Increased fracture risk was not seen in men.
  • Liver disease. On a positive note, several studies have indicated that pioglitazone may be helpful in treating non-alcoholic steatohepatitis (NASH), also known as non-alcoholic fatty liver disease. NASH is characterized by an inflamed liver caused by an accumulation of fat in the organ, and it is strongly associated with metabolic syndrome and obesity.

The FDA's approval of the first generic Actos offers patients with type 2 diabetes a more cost-effective form of the drug. Anyone who takes pioglitazone, or any medication, should be informed about all its risks and benefits before starting treatment.

SOURCES:
Boettcher E et al. Meta-analysis: pioglitazone improves liver histology and fibrosis in patients with non-alcoholic steatohepatitis. Alimentary Pharmacology and Therapeutics 2012 Jan; 35(1): 66-75
Food and Drug Administration
Heeboll S et al. Prognosis and treatment of non-alcoholic fatty liver disease and steatohepatitis. Ugeskr Laeger 2012 Feb 20; 174(8): 488-90
Mamtani R et al. Association between longer therapy with thiazolidinediones and risk of bladder cancer: a cohort study. Journal of the National Cancer Institute 2012 Aug 9. doi:10.1093/jnci/djs328

Image: Morguefile

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