Other safety alerts
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| United States: Ongoing safety review on Actos (pioglitazone) by the FDA |
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The U.S. Food and Drug Administration (FDA) announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug. The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug. FDA is reviewing the data from this observational cohort study and a case control study that is nested within it, and will update the public in several months when the review is complete or earlier should additional data become available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm
In Hong Kong, Actos is registered by Takeda Pharmaceuticals Taiwan, Ltd, and a total of 22 pioglitazone-containing products are registered in Hong Kong. Any new findings about Actos will be kept in view.
Ends/Monday, September 20, 2010
Issued at HKT 12:30
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