Sunday, January 15, 2012

Actos® European Recall and FDA Stance

A wave of recent studies which definitively link the prescription drug Actos—prescribed for Type 2 diabetes—to bladder cancer gives a fairly clear indication that Takeda Pharmaceuticals may soon be flooded with Actos lawsuits. August, 2011, saw the first Actos lawsuit filed by a 54-year old woman from Pennsylvania who had taken Actos for over a decade, then was diagnosed with bladder cancer. It is likely this particular victim may end up having her bladder removed and be subject to chemotherapy treatments due to the unexpected and severe side effects of Actos. Although the FDA has made substantial changes in labeling for Actos, they have refused to go as far out on the limb as other countries who have issued recalls of the drug.

France’s Medical Regulatory Agency made the decision to recall Actos once the serious side effects became known. Some 230,000 people regularly take Actos in France, and the possibility of an increase in bladder cancer was felt to be too great to allow patients to continue to take the drug. Soon after, Germany’s health regulators advised physicians to stop prescribing Actos for their patients with Type 2 diabetes due to the potentially dangerous side effects of the drug. These recalls and prohibitions were made after the European Medicines Agency conducted its own study of drugs which contained pioglitazone.

This study led Germany to change their initial warnings to physicians to include the statement that no new patients should be prescribed Actos due to its dangerous side effects. While the EMA did not issue an Actos recall for the entire European Union, it confirmed that this particular Type 2 diabetes drug put its users at a much greater risk for developing severe side effects, including bladder cancer. New Zealand has now scheduled its own recall of Actos due to perceived risks including heart failure, heart attack, stroke and bladder cancer just like the drug’s predecessor, Avandia.

Germany and France based their recall of Actos on a French study indicating an increased risk of bladder cancer in those taking the drug. The study was done on over 150,000 study participants who had taken Actos between 2006 and 2009, with findings of a 22% increase in bladder cancer in those who took Actos to control their Type 2 diabetes. In those who were using higher dosages of Actos, that figure was as high as a 50% increased risk of bladder cancer.

In 2007 the FDA recalled Actos for improper warning labels, however once that issue was resolved they allowed the drug back on the market. At present the FDA continues to examine the results of a ten year study done on over a million patients who have regularly taken Actos. Although mid-point results from the study indicated a possibility of increased bladder cancer risk, the results were less than definitive, leading the FDA to allow Actos to remain on the market until further results are in.

Actos is routinely prescribed for Type 2 diabetes when it is not being well-controlled by diet and exercise alone. Actos is manufactured by Takeda Pharmaceuticals, a Japanese corporation, and co-marketed by Eli Lilly in the United States. Actos is Takeda’s best-selling drug, making them over $3.4 billion dollars in 2010 alone. The FDA approved Actos in 1999, and it quickly became the most prescribed alternative to Avandia which had been linked to stroke and heart attack. The FDA issued a black box warning to be placed on Actos labels in 2007 after it was determined that Actos could increase the risk of congestive heart failure. June, 2011 saw yet another revision to the Actos warning label which now clearly states to Actos patients that they face an increased risk of bladder cancer should they take the drug for longer than a year. This FDA warning also includes combination drugs such as ActoplusMet, ActoplusMet RX and Duetact. It is estimated that Actos lawsuits will lead to payments between one and five billion dollars on at least 13,000 lawsuits.

Takeda Pharmaceuticals will continue its ten-year observational cohort study which included nearly 200,000 patients. The interim analysis was done in 2008 among patients with a median duration of Actos therapy of two years, and a range of three months to eight and a half years. After adjustments were made for age, sex, use of tobacco products and use of other diabetes medications there appeared to be no significant increase in the risk for bladder cancer in those who had taken the medication for short amounts of time or in small dosages. Those who had taken Actos for more than twelve months, however, showed an almost 40% increase in bladder cancer risk. Other studies have shown similar risks in those taking higher dosages of Actos or taking it for longer periods of time. Some believe the FDA approves drugs too quickly and is not as concerned with possibly jeopardizing patient safety as other countries appear to be.

Author: Sullo & Sullo Attorneys

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