Tuesday, April 10, 2012

Takeda Pharmaceuticals Received FDA Instructions for Diabetic Drug Actos

The drug Actos, also known as pioglitazone, has recently come under fire due to studies showing a slight increased risk of bladder cancer in those taking high doses of the drug or those who have taken Actos for longer than two years. Manufactured by Takeda Pharmaceuticals of Japan, the drug has shown huge gains in popularity in the past few years as it quickly replaced the drug Avandia which suffered under claims of increased risk of heart attack and death. Actos is Takeda’s tenth best-selling drug, making over $3.4 billion dollars in the past year alone. While the recent safety reviews have alarmed many who are currently taking the drug, in fact there have been safety concerns regarding Actos for several years.

Warnings are Not New
As far back as 2006, the FDA issued instructions to Takeda regarding Actos and ActoPlus Met, advising the company to make specific label changes to the drug’s precautionary statements. These label changes were to specifically include information regarding reports of bladder cancer in those taking Actos. Takeda’s supplemental drug applications regarding Actos were approved conditionally, so long as the agreed-upon text was included in the drug’s labeling.

The FDA stipulated that the final printed label be identical to the proposed labeling changes, and required Takeda to submit an electronic version of the proposed label as well as 20 paper copies and fifteen copies mounted on heavy-weight paper, however final approval was not mandated prior to using the labels. Although these FDA instructions took place nearly five years ago, it was only recently that more stringent warnings regarding Actos were issued.

Letters Issued to Health Care Professionals Prescribing Actos
At the same time the FDA asked for better warning labels, they requested that any letters sent to health care professionals regarding safety concerns of Actos also be sent to the NDA and FDA. Actos is prescribed for Type 2 diabetes, along with a nutritious diet and regular exercise, and is also found in a combination drug with Metformin to control the amount of sugar in the blood and help the body use insulin normally.

Recent Health Reviews
While the more recent health reviews of Actos have led to France and Germany pulling the drug from the market, the fnial recommendations state that Actos continues to offer significant benefits in carefully screened patients. Actos should not be used in those with a history of bladder cancer or in the elderly population, and those taking the drug should be monitored carefully, and kept at the lowest effective dosage.

Author: Sullo & Sullo Attorneys

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