Pioglitazone, or ACTOS, is a drug that was initially intended as a treatment to help manage Type 2 Diabetes. After an initial successful launch, it was withdrawn from the US markets because the risk that ACTOS was hurting Americans was shown to be too high. Not only was it removed from the American market, but a significant lawsuit was also initiated for people who were adversely affected by their prescriptions. Many other countries are now following the American lead and withdrawing their approval of the drug.
What it was supposed to do
ACTOS was designed to act as both a stimulant and modulator for the way that the body utilizes glucose metabolism and production, with the particular focus being on interacting with the liver. It reduces insulin dependence, decreased withdrawal levels of the glucose from the liver, and also reduces the amounts of glucose and related factors in the bloodstream. This is very important for people with diabetes as it helps to allow them to control their blood sugar and insulin requirements.
By suppressing the insulin and glucose presence in the bloodstream and liver, it returns the substances to a neutral level. A person with diabetes can then take appropriate replacements of glucose and insulin to create natural levels in their body. In some cases, where glucose is too high, a dose of ACTOS inhibits its production and presence enough to reduce it down to normal levels, and there is no need for additional insulin or glucose dosing.
ACTOS also has an additional proven effect on cholesterol levels, significantly reducing the amount of triglycerides and high-density lipoproteins present and changing the balance of LDL (the good cholesterol) and cholesterol in patients with disorders that usually require statins. ACTOS was thought to be a better way of treating cholesterol issues in patients with concurrent diabetes as it reduced the number of separate medications needed.
Why it was withdrawn
During short term testing, several things were found to be odd about ACTOS. While the majority of side effects were not serious, there was a sharp increase in the number of fractures in the upper body that was particularly noticeable in women. There was also an increased tendency for swelling and water retention in addition to edema.
Taken together, these side effects began to create the perfect environment for heart failure, and the FDA started to issue caution about its use for patients who were already at risk for myocardial infarction. It was the discovering of the dramatic increase in bladder cancer that led to it being withdrawn from the approved medication risk.
The FDA found that after four years, there was a 40% increase in bladder cancer in patients. This was deemed too high a risk for the drug to remain available. Unfortunately, by the time this discovery was made, many patients were far beyond the four-year mark. The result was a lawsuit that has yet to be fully settled.
ACTOS and Abuse
Another unexpected downside of ACTOS was its high abuse risk. While you wouldn’t expect a medication for diabetes and cholesterol to have a great appeal to addicts, there is one minor side effect that made it dangerously famous. There is little weight gain associated with taking ACTOS.
Because it inhibits and manages glucose and insulin levels, in a healthy person, it can affect the metabolism that can lead to (at minimum) weight control and (at maximum) weight loss. Many people began to abuse this drug as a means to control their weight while unaware of the health risks involved. It remains to be seen if anyone taking ACTOS without a prescription will be compensated in the lawsuit.