Submission of an opinion letter requesting that Actos (Pioglitazone Hydrochloride) be banned.
2011-09-29
Medwatcher Japan submitted an opinion letter to the Ministry of Health, Labor and Welfare (MHLW) and Takeda Pharmaceutical Company Ltd, requesting that the sale of Actos (Pioglitazone Hydrochloride) be suspended.
Actos is a type 2 diabetes drug that was approved in 1999 in Japan.
According to company estimates in 2009, 1,320,000 patients a year use it in Japan.
In June this year, the MHLW ordered the company to revise the package inserts and warn doctors to avoid prescribing Actos to patients with bladder cancer, based on new results from a French epidemiological study which reported that Actos is associated with an increased risk of bladder cancer.
Ahead of the MHLW’s decision, the regulatory agencies of France and Germany decided to suspend the sale of Actos to new patients.
The decisions of France and Germany are right because the balance between the risk and benefit of Actos is not positive.
While Actos brings with it a serious risk of bladder cancer and cardiac toxicity, there has been no proof that it reduces strokes, heart attacks, and complications caused by diabetes.
(In large-scale clinical trials at Takeda Pharmaceutical Company Ltd, the primary end point, which is a composite cardiovascular disease end point, failed to reach statistical significance.)
Therefore, the MHLW should ban the sale of Actos.
In 2000, Medwatcher Japan requested that the sale of Actos be stopped. We are now once again requesting this .
※ Patients currently using Actos should not stop taking it until they have consulted their physicians.
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