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Shezad Malik MD JD
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Actos Bladder Cancer Warning & Side Effects

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I am writing this Actos update, regarding the Actos dangerous drug cancer side effects.

Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks.

What is Actos?
Actos or Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes. Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body’s sensitivity to insulin, a hormone that controls blood sugar levels. Pioglitazone is not used to treat type 1 diabetes or diabetic ketoacidosis.

Fast FDA Facts About Actos
*Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).
*Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.
*From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.

Diabetes Drug Actos Bladder Cancer Risks
The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone).The agency’s warning comes five days after Germany and France pulled Actos from the market.

The warning comes after a review of data from a five-year analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

According to the FDA, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.Some medical experts believe that an Actos recall is imminent or that new warnings about the risk of bladder cancer from Actos should be added to the medication.

Research Data Summary
To address the long-term risk of bladder cancer associated with pioglitazone use, the drug manufacturer (Takeda) is conducting a ten-year, observational cohort study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan. Patients selected in this study had diabetes mellitus and were ≥40 years of age at study entry. The study group included 193,099 patients with diabetes.

The primary outcome of the cohort study is an incident (new) diagnosis of bladder cancer identified from the KPNC cancer registry. A planned five-year interim analysis was performed with data collected from January 1, 1997 through April 30, 2008.

The results showed that after adjusting for risk factors, there was no significant increase in the risk for bladder cancer in patients ever exposed to pioglitazone compared to patients never exposed to pioglitazone.

But, the risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk. The hazard ratio after more than 24 months of pioglitazone use was 1.4. Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone.

Possible signs or symptoms of Actos bladder cancer may include:

Blood in the Urine
Pain During Urination (Dysuria)
Frequent Urination
Feeling of Need to Urinate Without Results

Although it appears that information about the risk of Actos cancer problems has been known to the manufacturer for some time, inadequate warnings were provided to consumers and medical doctors. Further, it appears that the manufacturer may have placed their desire for profits ahead of patient safety by failing to adequately warn about the potential risk of bladder cancer. As a result, consumers diagnosed with bladder cancer may be able to obtain compensation through an Actos lawsuit.