The FDA approved Actos for treatment of diabetes in 1999. Patients have since reported side effects from taking Actos, one of the most serious of which is bladder cancer, an aggressive form of cancer. An August 2011 report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer. A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.

In September 2010 the FDA ordered a safety review of Actos. The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos. Although the risk of bladder cancer among this group as a whole has so far not appeared significant, a significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

In June 2011 the Food and Drug Administration released a safety communication to inform the public of a possible increased risk of bladder cancer in patients taking Actos for longer than one year. The FDA has required updated drug labels for drugs containing Actos as a warning to healthcare professionals and patients of a possible increased risk of bladder cancer when taking Actos for longer than one year. Drugs containing Actos include Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended-release), and Duetact (pioglitazone/glimepiride). The updated labels recommend that healthcare professionals should not prescribe Actos drugs to patients having bladder cancer and to use caution in patients with a prior history of bladder cancer. Patients are encouraged to contact their healthcare professional if they see any signs of blood in their urine, new or worsening pain on urination, urination urgency, or pain in the back or lower abdomen since taking an Actos drug, as these symptoms may be signs of bladder cancer.

In addition to the bladder cancer risks associated with Actos, other serious potential side effects of Actos include adverse cardiovascular events. Increased risk of heart attacks, heart failure, and related deaths have been attributed to Actos. Earlier studies comparing the cardiovascular safety of Actos and a similar drug Avandia indicated that Actos was a substantially safer alternative for the treatment of diabetes; as a result, Actos became more frequently prescribed than Avandia. More recent research suggests, however, that Actos may present a similar level of heart health risk to Avandia.

A study reported in 2010 by HealthCore Inc. compared the incidence of heart attack, heart failure or death in 28,938 patients taking Actos or Avandia from 2001 to 2005. The results showed similar risk levels between Actos and Avandia; approximately 4 percent of each patient group experienced a heart attack, heart failure or death, accounting for other conflicting factors including age, gender and prior heart disease. This study included death records and followed younger patients for a longer period of time, in contrast to a 2007 study of over 200,000 Medicare patients that showed no increased cardiovascular risk for Actos over Avandia. Unlike the 2007 study, the newer study did not include an analysis of strokes, however, which could account for some of the difference in risk observed.

An additional drug post-marketing safety study compared Actos to the drug Glyburide, a type II diabetes drug in the sulfonylurea class. Among a group of diabetic patients, overnight hospitalization for congestive heart failure was experienced by 9.9 percent of Actos patients versus 4.7 percent of Glyburide patients.

The American Heart Association and the American College of Cardiology have issued a joint science advisory to recommend close monitoring by healthcare professionals of patients taking Actos or Avandia, while additional research is carried out to clarify the extent of cardiovascular risks.

Concerned about the safety of prescribing diabetes drugs to patients with heart conditions, in 2007 the FDA issued “black box” warnings for increased risk of heart failure for both Actos and Avandia. The warnings did not include increased risk for heart attacks, the FDA not having yet reached a conclusion on the increased risk from use of these drugs.

The FDA has found a potential safety concern, although not a causal link, that Actos may lead to rhabdomyolysis and kidney failure. Rhabdomyolysis is a rare condition causing rapid muscle fiber breakdown, resulting in buildup of the muscle protein myoglobin in the bloodstream. Myoglobin is toxic to kidneys, so that rhabdomyolysis can lead to kidney failure and death. Other symptoms of rhabdomyolysis are muscle pain and weakness, fever, nausea, and dark urine. While the FDA has not yet determined that regulatory action is necessary, it is continuing to evaluate this potential safety issue and will keep healthcare professionals and the public informed.

If you think that you or a loved one may have suffered a serious side effect related to taking Actos, you may have valuable rights. It is important that you retain all pertinent medical records and bills to help you obtain any compensation to which you may be entitled. It is also important for you to speak with a qualified drug injury attorney about your rights and your potential for any compensation that may be due to you and your family.

Sullo & Sullo, LLP has an experienced team of attorneys who can help you to investigate your rights and your lawsuit options.

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