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Diabetes drug Actos banned in India

10 July 2013 | Regulatory | By BioSpectrum Bureau

Indian Health Ministry has banned popular diabetes drug Actos from being sold in the country after increased risk of bladder cancer associated with the drug was revealed

Indian Health Ministry has banned popular diabetes drug Actos from being sold in the country after increased risk of bladder cancer associated with the drug was revealed

Singapore: The Indian Health Ministry has banned the blockbuster diabetes drug Actos along with suspending sales of pain killer Analgin and anti-depressant Deanxit.

The blockbuster diabetes drug Actos (pioglitazone) has been banned in India in an effort to prohibit the sale of medicines based on allegations of adverse side effects.

"Ever since the FDA issued its safety announcement in June 2011 that Actos may be linked with bladder cancer, we have carefully monitored the adverse event reports received by the agency. We support India's decision to ban Actos within their country," said Charles Balkin, founding partner of Balkin & Eisbrouch, LLC, a national law firm that represents clients who have been injured by dangerous drugs.

India's Ministry of Health and Family Welfare has banned the manufacture and distribution of Actos, Deanxit and Analgin under Section 26A of the Drugs and Cosmetics Act, 1940, effective immediately within India.

The insulin-sensitizing medication prescribed to Type 2 diabetics, Actos has been centered in controversy across the globe. The drug was pulled off the France and Germany markets in 2011 after research revealed a possible increased risk of bladder cancer among Actos patients as high as 22 percent. Although the drug is still prescribed in the US, it carries a strict warning cautioning of a possible heightened risk of bladder cancer when taken for more than one year. It also contains FDA's strictest warning (a black box warning) about the potential link of Actos with heart failure.

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