Mr. Fromson is a Partner with Finkelstein & Partners, LLP, and he participates in the firm’s litigation involving dangerous drugs.
Being a diabetic is tough enough and monitoring your blood sugar just got tougher. Users of the drug, Actos, who already have to confront its association with heart failure, now confront another concern: bladder cancer. And those patients who have suffered bladder cancer while ingesting Actos, and other pioglitazone-containing medicines, are inquiring whether the makers of Actos adequately warned of the bladder cancer risk. Last week, the U.S. Food and Drug Administration (FDA), approved updated drug labels for pioglitazone-containing medicines to include safety information that the use of pioglitazone may be associated with an increased risk of bladder cancer. The active ingredient in Actos, Pioglitazone, is also used in ActoPlus met, ActoPlus met XR and Duetac to treat Type 2 Diabetes. The updated drug labels recommend that healthcare professionals should not use pioglitazone in patients with active bladder cancer and that pioglitazone should be used with caution in patients with a prior history of bladder cancer. This labeling revision follows on the heels of FDA’s June 2011 Drug Safety Communication where FDA indicated that ACTOS use of more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. The ACTOS product labeling as of 2011 did not inform as to a causal relationship with bladder cancer. Rather, after summarizing animal studies with rats, as well as two 3-year trials in which ACTOS was compared to placebo or glyburide, the labeling stated there were too few events of bladder cancer to establish causality. Although the occurrence of such cancers in animal test subjects during pre-market studies was well know to regulatory agencies and the manufacturer, Takeda, Inc., the drug Actos, as well various combination therapy regiments that incorporate Actos, have been used to treat Type 2 Diabetes since 2000, without warning of a causal relationship of the drug to bladder cancer. According to the FDA, over 2.3 million prescriptions for the drug were issued in the United States in 2010. The drug manufacturer (Takeda) is now sponsoring long term studies regarding patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan. But a shorter five-year analysis (1997 – 2008) of pioglitazone exposure longer than 12 months, compared to never being exposed to pioglitazone, was associated with a 40% increased risk of bladder cancer. In 2010, a case control study in the Journal, Cancer, discussed the increased risk while also recognizing the already existing association between bladder cancer incidence and diabetes, wherein it stated “Our findings support an association between bladder cancer incidence and diabetes, and further suggest that the risk may be greater among patients taking oral hypoglycemics and those with diabetes of longer duration.” Cancer 2010. © 2010 American Cancer Society. Earlier this year, the European Medicines Agency (EMA) — Europe’s equivalent of the FDA — announced that France had already pulled from pharmacy shelves pioglitazone-containing medicines (Actos, Competact). The EMA announcement indicated “[t]his decision by the French authority follows receipt of results of a retrospective cohort study carried out in France which became available today. These results appear to suggest an increased risk of bladder cancer with pioglitazone.” Determining whether ACTOS or other pioglitazone-containing medicines contributed to an individual’s bladder cancer requires a case-sensitive in depth review of medical history. Individuals who smoke are at greater risk for bladder cancer, and so are people who have exposure to toxic chemicals such as arsenic, phenols, aniline dyes, and arylamines. Dye workers, rubber workers, aluminum workers, leather workers, truck drivers, and pesticide applicators may be at a higher risk, too. Also, long-term chronic infections of the bladder, irritation due to stones or foreign bodies are some other factors which predispose individuals to bladder cancer. If you or anyone you know has been diagnosed with bladder cancer and was prescribed Actos, ActoPlus met, ActoPlus met XR or Duetac (Pioglitazone) to treat Type 2 Diabetes, contact Finkelstein & Partners, LLP, for a free evaluation of your case.