Actos Concerns Go Global

Indian Drug Makers Fight Ban on Actos


At the end of June, the government of India suspended the sale of three drugs that had been pulled from pharmacy shelves in other countries – Alagin (a painkiller), Deanxit (a depression medication), and the infamous, now-off-brand Actos.

Actos was banned in France and Germany in 2011, when the countries cited severe safety concerns. That same year, the US forced Actos manufacturer Takeda Pharmaceuticals that they had to put the FDA’s most serious warning label on the box, although the drug was never officially recalled.

Now, India has decided, according to their Drugs and Cosmetics Act 30-B, that they will pull Actos, and possibly other pioglitazone generics. And Indian drug manufacturers are not happy.

Companies that manufacture generic forms of Actos in India argue that the government has not followed proper regulatory protocols. “We are demanding a review,” said Indian Pharmaceutical Alliance chief D.G. Shah (as quoted by the Business Standard). “A ban has to be based on science … [and] it has to follow a proper process.”

According their own regulatory process, the Indian government is supposed to consult drug manufacturers before outright banning pharmaceuticals such as Actos. If the government does not offer to consult with these companies soon, Shah says, drug manufacturers may sue for the right to continue producing generic forms of Actos.

“This drug is in use in most advanced markets of the world, be it the US, Japan or the UK. I believe the DCGI has invited comments and responses from the industry and it should come up for review, which would be a very welcome step,” Lupin group president, India and CIS (Commonwealth of Independent States) Shakti Chakraborty told Business Standard. Lupin is one of the pharmaceutical manufacturers in India which produces a generic version of Actos.

Plaintiff in US Actos Bellwether Case Seeks $10 Million in Damages

While India decides whether or not to ban Actos and its generic forms outright, personal injury lawsuits against Takeda Pharmaceuticals are well underway.

In the District Court of Louisiana (Lafayette), plaintiff Anthony Vavalle and his wife, Sandy, are suing the manufacturer for personal injury related to Actos use. The 60-year-old Vavelle was diagnosed with Type II diabetes in December 2008, and like too many patients at the time, he was prescribed Actos to treat his condition.

Just two years later, Vavalle was diagnosed with bladder cancer – a disturbingly common side effect from taking Actos.

According to many studies in the last several years, using Actos for two years or more dramatically increases a patient’s chances of developing bladder cancer. Other complications can arise from taking Actos as well, including liver damage and macular edema. While people with Type II diabetes are susceptible to these conditions anyway, taking Actos has been linked to greater risk.

Vavalle’s lawsuit is the latest bellwether case in MDL No. 2299. He seeks $10 million in damages for lasting physical injuries, emotional distress, medical bills, and significant pain and suffering.

In many Actos personal injury lawsuits, plaintiffs’ lawyers also allege that Takeda Pharmaceuticals “willfully, wantonly and with malice withheld” study results from patients using Actos and their healthcare professionals. The manufacturer began a three-year study into the safety of Actos in 2005, after receiving complaints about dangerous side effects.

The Strom Law Firm Can Help with Personal Injury and Wrongful Death Cases, Including Against Actos

If you or a loved one have taken Actos to treat Type II diabetes, and have since suffered dangerous side effects including developing bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation. The attorneys at the Strom Law Firm can help with personal injury cases, including against Actos manufacturer Takeda Pharmaceuticals. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us803.252.4800

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

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