Attached is a blog submitted by Elizabeth Carrollton who wants to alert us to the relationship of a diabetes drug, Actos, and bladder cancer.
When diet and exercise aren’t enough, medical professionals turn to trusted medications to help type 2 diabetes patients live longer and healthier lives. But many of the medicines that are aimed at improving diabetes can have the opposite effect on other bodily functions.
One of the most popular type 2 diabetes drugs on the market, Actos (pioglitazone), is also one that comes with the biggest dangers. Studies have linked this popular once-daily pill to an increased risk of bladder cancer, congestive heart failure (CHF), edema and other life-threatening conditions.
Worldwide, drug regulators have put the brakes on Actos. But in the United States, drug regulators have allowed Takeda Pharmaceuticals to continue its prolonged study into its drug while sales continue. The U.S. Food and Drug Administration (FDA) has done little to protect vulnerable Actos patients.
Evidence in Scientific Studies
Since Actos belongs to the thiazolidinedione drug family, medical professionals have had their doubts about the drug. The two other drugs in this family, both of which were also used in diabetes patients, have been pulled from pharmacy shelves because of serious medical dangers.
Even before Actos was mass marketed in 1999, clinical trials indicated problems. Studies showed links between Actos and bladder cancer, CHF, bone fractures, edema and blindness. Instead of holding the drug back for more research, Takeda launched a 10-year study into bladder cancer risks while sales of the drug skyrocketed. When the drug’s link to CHF was pinpointed, the FDA gave the drug a black-box warning instead of taking it off the market. (The black box is the strongest type of warning the FDA can require.)
Banned in Europe; Whistleblowing in the U.S.
Even after the initial results of Takeda’s bladder cancer study revealed that Actos patients taking the drug for longer than a year had a 40 percent increased chance of getting the disease, the FDA did little to regulate it. Instead, in 2011, the FDA added yet another warning to the drug’s label. At the same time, France, Germany and Canada took steps to restrict or remove the drug from the market.
Adding to the skepticism about Takeda’s truthfulness regarding Actos, a former medical reviewer for the company filed a federal whistleblower lawsuit. Dr. Helen Ge said that Takeda repeatedly lied to the FDA about the drug’s safety record.
Doctors Make Other Choices
While the FDA waits for Takeda to finish and publish its final bladder cancer study results in 2013 — and as the whistleblower’s Actos lawsuit makes its way through the court system — Actos continues to be readily available. However, many medical professionals have been opting to instead prescribe type 2 diabetes drugs with better safety records.
Bottom Line (by Neil Baum): Patients taking ACTOS should see their doctor and obtain a urine test and a urine cytology. If either of these tests are abnormal, then a cystoscopy is in order. This is a test to look into the bladder with a small, lighted tube to be sure no bladder tumors are present.
Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.