actos

FDA announces preliminary safety review of pioglitazone

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The FDA is evaluating preliminary results from a long-term, observational study suggesting patients assigned pioglitazone may be at increased risk for bladder cancer. As of press time, the FDA’s review is ongoing and they have not confirmed an association between pioglitazone and bladder cancer risk.

According to the FDA, the preliminary data are based on 5-year results from an ongoing, 10-year study conducted by Takeda Pharmaceuticals. Although preliminary findings indicated no association between exposure to pioglitazone (Actos, Takeda) and risk for bladder cancer, there was an increased risk among patients with the longest duration of exposure to the drug as well as in those assigned the highest cumulative dosage.

Pioglitazone is prescribed to control blood glucose in patients with type 2 diabetes. The only other drug in this class is rosiglitazone (Avandia, GSK). FDA officials have no clinical data suggesting an association between rosiglitazone and bladder cancer. However, following an FDA advisory committee meeting back in July, officials recommended restrictions be placed on the use of rosiglitazone in addition to revised labeling that includes additional warnings about cardiovascular safety.

The FDA recommends for patients to discuss any concerns with their health care professional. Patients should not stop taking pioglitazone unless told to do so by their health care professional.

Thiazolidinediones and Bladder Cancer Revisited.

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Prolonged TZD use might cause bladder cancer.

In several studies, the diabetes drug pioglitazone (Actos) has been associated with risk for bladder cancer (JW Gen Med Jun 21 2012). In this retrospective study, researchers used a U.K. database to compare the incidence of bladder cancer in 18,000 users of thiazolidinedione (TZD) drugs (i.e., pioglitazone and rosiglitazone [Avandia]) and 41,000 users of sulfonylureas. Although median follow-up was about 3 years, follow-up exceeded 5 years in 25% of patients.

Overall, 197 bladder cancers were diagnosed (about 1 case per 300 patients). After adjustment for potential confounders, risk for bladder cancer was significantly higher after 5 years of TZD use (hazard ratio, 3.42 for 5-year users compared with risk in <1-year users). Moreover, 5 years of TZD use was associated with higher incidence of bladder cancer than 5 years of sulfonylurea use (HR, 2.53); with shorter durations of use, incidence was similar in the TZD and sulfonylurea groups. Pioglitazone and rosiglitazone conferred similar risks.

Comment: The evidence for an association between TZDs and bladder cancer — albeit mostly from observational studies — is mounting. The mechanisms are unclear: In basic science studies, agonists of PPAR– (the TZD receptor) affect cell differentiation and proliferation in various ways. In any case, we have little reason to prescribe TZDs, which are not essential for managing diabetes and which are associated with other adverse effects.

Source:Journal Watch General Medicine

 

New Drug Approvals: Generic Actos, Tradjenta Indication, CFC-Free Inhaler OTC .

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Several new drug approvals or indications were announced last week. Here are the ones you might be most interested in:

  • Generic Actos: The FDA approved the first generic version of Actos (pioglitazone) for glucose control in patients with type 2 diabetes.
  • New Tradjenta indication: The oral antidiabetic Tradjenta (linagliptin) can now be used as add-on therapy to insulin in patients with type 2 diabetes. Previously, it was reserved for use as an adjunct to diet and exercise, or in combination with other oral diabetes agents.
  • Over-the-counter, CFC-free asthma inhaler: Asthmanefrin — an over-the-counter, chlorofluorocarbon-free epinephrine inhaler — is now available. It will help fill the void left when Primatene Mist was discontinued in 2011 because of its CFC propellant, the manufacturer says.

Source: FDA

Generic version of pioglitazone receives FDA approval.

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The FDA announced today that it has approved the first generic version of pioglitazone tablets, which are used in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes.

According to a press release, Mylan Pharmaceuticals gained FDA approval for the 15 mg, 30 mg and 45 mg tablets.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” Gregory P. Geba, MD, MPH, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

Pioglitazone (Actos, Takeda) is dispensed with a patient medication guide that provides important instructions about its use and drug safety information. The drug also has a boxed warning to emphasize that pioglitazone may cause or worsen heart failure, particularly in certain patient populations. The agency recommends careful monitoring of patients when starting the drug or increasing the. Additionally, the product label states that the use of pioglitazone for more than 1 year is associated with the risk of bladder cancer.

The most common side effects reported by patients using pioglitazone include headache, sinus infection, muscle pain and sore throat.

Source: Endocrine Today.

Pioglitazone Is Associated with Excess Risk for Bladder Cancer.

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Using pioglitazone for >2 years or exceeding a cumulative dose of 28,000 mg imparted the highest risk.

In 2011, the FDA issued a safety warning for the antidiabetic drug pioglitazone (Actos). The warning states that use for longer than 1 year might be associated with excess risk for bladder cancer, based on data from a French study and an interim analysis of a manufacturer-sponsored, U.S. observational study. U.K. investigators now report on a case-control study in which they evaluated the same outcome.

Researchers identified 116,000 patients (mean age, 64) with type 2 diabetes who were new users of oral antidiabetic drugs. After a mean follow-up of 4.6 years, 470 patients had received diagnoses of bladder cancer (89 cases per 100,000 person-years). Each patient with bladder cancer was matched with as many as 20 controls. Ever use of pioglitazone was associated with 83% higher risk for bladder cancer — a significant increase — compared with never users. The bladder cancer rate increased significantly with duration of pioglitazone use, with the highest rates in patients who were exposed for >2 years, and in patients whose cumulative dose exceeded 28,000 mg. Notably, no excess risk for bladder cancer was observed for patients who received rosiglitazone (Avandia).

Comment: In this study, pioglitazone use was associated with excess risk for bladder cancer in patients with type 2 diabetes. Because these findings reinforce the FDA warning, clinicians and patients should weigh carefully the benefits and risks of using this drug.

Source:  Journal Watch General Medicine