Monday, May 14, 2012

Actos® Adverse Effects

Many of us would be very surprised to find that a drug can be approved by the FDA yet still have serious—and undisclosed—side effects. The drug Actos, used in the treatment of Type 2 diabetes, is one such drug. Actos works by decreasing the body’s resistance to insulin as a way of controlling blood sugar levels. Actos is currently being used by millions of people across the globe, with sales jumping from around $2.9 billion in 2006 to over $4.3 billion in 2010. Actos has often been prescribed in place of the drug Avandia, which was found to carry significant risks of heart disease and possibly even death in 2007. Actos, which is manufactured by the Japanese pharmaceutical giant Takeda Pharmaceuticals, has recently fallen under scrutiny as well as studies have linked it to an increased risk of bladder cancer as well as correlating it to other serious diseases such as heart attack, stroke and liver failure.

“Minor” Side Effects of Actos
The truth is, all prescription medicines as well as most over-the-counter medications, carry some risk of adverse effects. Fortunately the incidence of serious side effects is rare and for the most part the majority of people have either no side effects or relatively minor ones. Minor side effects associated with Actos include flu-like symptoms, headaches, toothache, sore throat or sinus pain and weight gain. More serious side effects which should prompt the user to seek medical attention include an allergic reaction which includes difficulty breathing or chest tightness, blurry vision, symptoms of heart or liver failure including breathing difficulties, a sudden gain in weight, stomach pains, dark urine, jaundice or vomiting, low blood sugar symptoms such as tremors, anxiety or chills, severe and unusual bone pain and total exhaustion along with feeling weak and shaky.

More Serious Adverse Effects from Actos
In general, the side effects of Actos were found to be similar to the side effects of Actos used in combination with sulfonylurea, metformin or insulin other than an increase in edema when Actos was combined with insulin therapy. Almost 200,000 patients with Type 2 Diabetes who took Actos to control their disease, were involved in a Northern California research study. Alarmingly, the study found that those taking Actos for any length of time past twelve months were at a 40% higher risk of developing bladder cancer than those not taking the drug. Prior to the release of this study, Takeda disclosed no cancer warnings on their labeling information sheet or the patient medication guide. Other studies are now indicating that those patients who took the highest dosages of Actos or took it for at least two years with a cumulative dosage of greater than 28,000 mg faced the highest risks of developing bladder cancer.

While the FDA has compelled Takeda to adjust their labeling to include warnings about possible increased risks of bladder cancer, the United States is holding off pulling the drug until results of further studies are in. Other countries are not so relaxed about the drug with New Zealand scheduling a recall of Actos, and France and Germany already suspending sales of the drug. The French National Health Insurance Plan studied data from a million and a half patients with Type 2 diabetes, finding a “statistically significant increase” in the risk of bladder cancer in those taking Actos as compared with those taking other anti-diabetic drugs. Unfortunately the bladder cancer risk is not the only serious adverse effect noted in those taking Actos.

Cardiovascular Risks and Side Effects from Actos
As noted, once the cardiovascular risks of the Type 2 diabetes drug Avandia were made public, Actos was seen as a much safer alternative, causing sales to skyrocket. Both Avandia and Actos belong to the class of drugs known as thizolidinediones which are considered to be among the strongest medications for Type 2 diabetes. Both Actos and Avandia work by reducing body tissue insulin resistance while adjusting cholesterol levels simultaneously. The risk of heart attack, stroke and cardiovascular disease was found to be 30-40 percent higher among those taking Avandia, and initially Actos was not felt to carry this same risk.

In 2010, however, the FDA stated Actos would carry what is known as a “black box warning” regarding cardiovascular risk. Those with Type 2 diabetes who also have any type of heart disease, no matter how mild, or any kidney disease could be at a significantly increased risk of developing congestive heart failure while taking Actos. Congestive heart failure occurs when the heart is unable to pump sufficient blood to maintain adequate circulation in the body, leading to a fluid buildup in the lungs.

Bone Fractures Seen in Certain Groups Taking Actos
In another study, women over the age of 50 who suffered from broken bones and osteoporosis were found to be over 70% as likely to have been prescribed a thiazolidinedione drug such as Actos. The types of fractures seen in this study were not the same sort as those seen in people with osteoporosis, such as spine and hip fractures, but also included arm and leg fractures. In short, women with Type 2 diabetes over the age of 50 who were taking a thiazolidinedione drug were much more likely to suffer from some form of osteoporosis and bone fractures.

Actos has also been shown to raise the level of liver enzymes, meaning there is a possibility of liver damage when taking the drug. If you have experienced any of the side effects associated with Actos, it is imperative you consult your physician.

Author: Sullo & Sullo Attorneys

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