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Steve Thomas
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New drug carries Actos’ increased bladder cancer risk

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A new Takeda type-2 diabetes drug contains an older Takeda type-2 diabetes drug that is associated with an increased risk of bladder cancer.

The U.S. Food and Drug Administration on Jan. 25 approved three new Takeda diabetes medications. Among them is a tablet therapy that would be marketed as the brand name Oseni, a blend of Takeda’s new Nesina (alogliptin) and its pre-existing Actos (pioglitazone).

Actually, the manufacturer is marketing the generic alogliptin under three brand names. Nesina is the stand-alone drug. Kazano is alogliptin combined with metformin. Oseni is the third brand.

Actos comes in two forms now, by itself and in a drug combination. Actos lawsuits have been filed in numerous states by patients who have developed bladder cancer that has been presumptively linked to the drug’s increased risk.

The experienced Actos attorneys at Reich & Binstock represent Actos bladder cancer victims in their pursuit of compensation for medical expenses and other losses. Reich & Binstock continues to offer free consultations to diabetics whose bladder cancer may be linked to taking a drug that is distinguished by its unreasonable risk. A lot of those patients did not even know about risks that the manufacturer should have known and promulgated.

But the bladder cancer risk is not lost on Oseni.

Accordingly, Oseni’s “Warnings and Precautions” for health care professionals include the following statement: “Data suggest an increased risk of bladder cancer in pioglitazone users. Data also suggest that the risk increases with duration of use. Do not use Oseni in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria or urinary urgency as these may be due to bladder cancer.”

Prompted by prevailing science, the FDA on Aug. 4, 2011, issued a statement “informing the public that the agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public on June 15, 2011.”

Reinforcing the risk, in its October 2011 release of consumer medication information, the American Society of Health-System Pharmacists reported, “In clinical studies, more people who took pioglitazone for more than one year developed bladder cancer than people who did not take pioglitazone. Talk to your doctor about the risk of taking this medication.”

Although data will be collected through December, interim results from a California study are consistent. The findings were from a joint Takeda and Kaiser Permanente Northern California study that tracked patients from January 1997 through December 2010.

As of an October 2012 update, the Actos-treated group, numbering more than 33,000, filled at least two Actos prescriptions within a six-month period. In the other group, nearly 160,000 were treated solely with other drugs for their type-2 diabetes. The incident new bladder cancer diagnoses were expressed as adverse events per 100,000 person years: 82.3 for those who took Actos and 72.6 for those who did not. Moreover, the bladder cancer incidence increased with the duration of the Actos regimen. Additional data will be collected in the balance of 2013.

In the meantime, Actos has gone generic, but, just like with Oseni, the warnings were not gone with the wind. The FDA on Aug. 17, 2012, approved the first generic version of Actos. The FDA’s announcement explained that the Mylan generic’s “product label also notes that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”

To reach one of the pharmaceutical injury attorneys at Reich & Binstock for a free consultation as to an entitlement to compensation, one may either submit an electronic request for free legal advice through Reich & Binstock’s Web site, www.reichandbinstock.com, or call toll-free at 1-866-LAW-2400.

“As the most common form of the disease, type-2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States,” according to an FDA statement that concerned the approvals.