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Actos subject of U.S., foreign clinical study

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While the U.S. Food and Drug Administration plays it safe in regard to the apparent increased risk of bladder cancer associated with taking the type-2 diabetes drug Actos (pioglitazone), the results of an international study soon will become fodder either for or against that finding.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company completed primary-data collection in March on more than 900 type-2 diabetics ages 18 to 80 who have been scattered throughout the United States, Estonia, Germany, Latvia, Spain and the United Kingdom. The subjects have been participating in a clinical study that began in 2010 comparing the efficacy of Tradjenta (linagliptin) and Actos both independently and as a joint therapy at several dosage levels.

Tradjenta is a Boehringer Ingelheim type-2 diabetes drug that the FDA approved in 2011. The FDA initially approved Actos, which is made by Takeda, in 1999. Takeda in 2012 and in early 2013 has been bracing for generic competition against Actos, thusly giving pioglitazone a second wind in a new generic diabetes product.

The primary data of the domestic and foreign study ideally will show the comparative levels of “change from baseline in HbA1c after 30 weeks of treatment.” A secondary outcome will be an analysis of adverse events that will have arisen during an 84-week period.

One apparent Actos side effect is bladder cancer. Victims have filed Actos lawsuits, asserting, among other claims, the manufacturer either knew or should have known and should have properly warned about the increased risk of bladder cancer.

It took a dozen years for the proper warnings to be issued, a period long enough to allow a first grader to become a college freshman.

The FDA in 2011 approved updated labels for all pioglitazone-containing medications to reflect that “the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”

FDA officials obtained new data before they spearheaded the label revision. Midway through a 10-year epidemiologic study, FDA officials learned that “although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”

Playing it safe from a public health perspective, the FDA OKd the bladder cancer warning as it has continued to monitor, and to be open to, new scientific contributions.

Millions of patients were exposed to what Actos lawsuit plaintiffs would characterize as an unreasonable and uninformed increased risk of bladder cancer. At the same time that the FDA announced pioglitazone re-labeling, the agency reported that from “January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.”

Long-term studies, magnifying the incidence of bladder cancer among pioglitazone patients, have implications for other drugs. If pioglitazone is the bladder cancer culprit that science says it is, then consumers of medications other than Actos may be exposed to the increased risk of the disease; hence pioglitazone warnings are on everything that contains the drug.

Why are there more drugs spreading the increased bladder cancer risk? This phenomenon goes to the nature of the pharmaceutical industry, in which pipelines of emerging brands pump the lifeblood that immunizes against penury.

Pharmaceutical corporations must re-invent their revenue streams due to the inevitable lapse of brand-name drug patents and the ensuing competition from manufacturers of the generic versions. Takeda has felt such market pressure in regard to Actos, writing in its 2012 annual report, “[W]e are developing a strategy to generate stable growth from fiscal 2012 (ending March 31, 2013), when we expect Actos to encounter generic competition in the U.S.”

Although Actos, as a brand, will have to match up in the prescription drug market with cheaper generic pioglitazone, Takeda has accounted for that by infusing its type-2 diabetes portfolio with new life in the new year of 2013. Takeda announced Jan. 25 that the FDA approved, among other Takeda drugs, Oseni, a blend of alogliptin and pioglitazone, the latter the same familiar substance that Actos contains and that carries the increased risk of bladder cancer.

Anyone who has taken Actos and who has been diagnosed with bladder cancer may want to contact one of the Actos attorneys at Reich & Binstock, experienced pharmaceutical injury lawyers who operate in every state. Call the law firm toll-free at 1-866-LAW-2400. Visit www.reichandbinstock.com.