India yanks Takeda's Actos on safety concerns

Two other older meds also get the regulatory ax
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Why now? That's a fair question about India's move to suspend the sale of three drugs, including Takeda Pharmaceuticals' now-off-patent blockbuster, Actos. The country's health ministry also banned Analgin, a decades-old painkiller, and Deanxit, a combination pill for depression.

All three of these drugs have been suspended from one market or another, though Actos remains on sale in major markets, including the U.S. and U.K. Apparently, India could and should bar drugs that are banned in their home countries under its Drugs and Cosmetics Act 30-B, but officials have stalled in some cases, India Today reports. Now, however, the government is looking closely at banning drugs prohibited in the U.S., U.K., Canada, Japan, the EU or Australia.

Analgin, sold in India by Sanofi ($SNY) and a handful of dominant generics producers, was barred from sale in Sweden some 36 years ago. Other countries, including France, Japan and Australia, have also pulled the drug. Meanwhile, Deanxit, an antidepressant made by Danish drugmaker Lundbeck, was previously banned in the company's home country. The health ministry held off suspending those meds for many years despite pressure from Parliament, India Today says.

And then there's Actos. Studies have linked the diabetes drug--in the same class as the controversial Avandia pill from GlaxoSmithKline ($GSK)--to an increased risk of bladder cancer. France has suspended its sale, but it's still used worldwide, including in the U.S. The FDA, in fact, has reviewed the evidence and added a bladder cancer warning to the drug's label. A previous black box warning highlights the risk of congestive heart failure.

Safety concerns had begun to erode Actos sales before it went off patent in the U.S. last August. Nonetheless, Actos brought in 122.9 billion yen for Takeda last year, or about $1.5 billion, down from $4.3 billion in 2010. Sales have been plummeting on generic erosion, and Takeda has been restructuring, laying off workers and cutting other costs to cope. The company also faces 10,000 or so lawsuits over Actos safety in the U.S.

In India, the market for Actos and its generics amounts to some 1 billion rupees, or about $116 million. In addition to Takeda, the ban affects a raft of Indian companies, including Ranbaxy Laboratories, Wockhardt and Sun Pharmaceutical Industries.

- read the India Today story

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