CardioExchange Archive

July 21st, 2011

FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone

Larry Husten, PHD

The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication about […]

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June 16th, 2011

FDA Says Pioglitazone Use Is Linked to Bladder Cancer

Larry Husten, PHD

The FDA has issued a safety announcement stating that the use of pioglitazone (Actos) for more than 1 year may be  associated with increased risk for bladder cancer. The FDA announcement follows last week’s suspension of the drug in France and Germany by regulatory authorities in those countries. The FDA said that pioglitazone should not be […]

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June 9th, 2011

Pioglitazone (Actos) Suspended in France Over Cancer Concerns

Larry Husten, PHD

Sales of the popular diabetes drug pioglitazone (Actos, Takeda) have been suspended in France after a study carried out by the French health insurance fund (CNAM) found that it may increase the risk of bladder cancer. The French regulatory agency (AFSSAPS) said that new prescriptions for drugs containing pioglitazone may no longer be written, but […]

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March 24th, 2011

Study Finds Pioglitazone Prevents Progression To Diabetes

Larry Husten, PHD

Pioglitazone significantly reduces the development of type 2 diabetes in people with impaired glucose tolerance, according to the results of the ACT NOW study published in the New England Journal of Medicine. Ralph DeFronzo and colleagues randomized 602 patients with impaired glucose tolerance to pioglitazone or placebo. During a median followup of  2.4 years, diabetes developed […]

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March 17th, 2011

Meta-Analysis Suggests Worse Outcomes For Rosiglitazone Compared To Pioglitazone

Larry Husten, PHD

There are no long-term trials directly comparing rosiglitazone and pioglitazone. In an article published in BMJ, Yoon Kong Loke and colleagues performed a systematic review and meta-analysis of 16 observational studies with more than 800,000 thiazolidinedione users in an attempt to assess the relative cardiovascular effects of the two drugs. When compared with pioglitazone, rosiglitazone was […]

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September 17th, 2010

FDA Announces Safety Review of Pioglitazone

Larry Husten, PHD

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of […]

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