There have been hundreds of lawsuits filed against Takeda Pharmaceuticals Co. Ltd., the maker of Actos, the world’s best-selling diabetes drug. Evidence continues to mount indicating that taking the pill for more than a year raises the risk of bladder cancer. In June, Takeda halted sales of Actos, its top drug, in Germany and France as a result of increased pressure from regulators. Since then, both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research. But interestingly, they have allowed sales to continue.
Doctors are being told not to prescribe Actos for people who now have or who in the past have had bladder cancer. The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that came to the market more than a decade ago with a heavy marketing campaign. There were some good things about the drug. It helped control blood sugar tightly, had few side effects in most patients, boosted the effects of some other diabetes drugs, worked by a new mechanism – improving the body’s sensitivity to insulin – and even allowed patients to reduce or delay use of injected insulin. But there were side effects.
Actos, despite links to heart failure risk and other serious side effects, became the number one diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. As we have previously reported, Avandia’s use was banned in the EU and sharply restricted in this country. As a result, Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.
When a manufacturer distributes a drug for sale to the public, it owes a duty to ensure that its product is safe for use. Based on all that is now known, it appears that Takeda Pharmaceuticals breached that basic duty with Actos. Takeda, which is based in Japan, has issued statements that it’s committed to keeping Actos available for patients who need it. The FDA analyzed data from the first five years of a ten-year Actos safety study Takeda begun in 2002 and concluded this June that risk of bladder cancer was 40% higher for patients taking Actos for at least a year. We will continue to follow developments relating to the drug. If you need more information, contact Roger Smith, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
Source: Insurance Journal
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