FDA approves generic Actos in the midst of brand name lawsuits

Last Friday, the FDA approved a generic version of type 2 diabetes drug Actos. Even if you don’t suffer from the adult-onset disease, you’ve likely heard the name Actos in the news. Hundreds of people have sued the drug’s manufacturer, Takeda Pharmaceuticals, for failing to warn of serious adverse side effects, including the risk of bladder cancer.

As you may have also heard, and as MedicineNet states, “Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.”

That being said, West Virginia-based Mylan Pharmaceuticals, the maker of the generic Actos, was forced to add a bladder cancer warning to its label. And since studies have also shown that Actos may cause heart failure in some individuals, the generic version’s label warns of this as well.

If your doctor prescribes the generic version of Actos, if your insurance company only approves your pharmacy to give you the generic version of Actos, or if you take the generic version because it’s less expensive, please be sure to review the label and accompanying guide. If you’re unsure of something, talk to your pharmacist.

Please also note that, in 2011, the Supreme Court ruled that you cannot sue a generic drug manufacturer for failing to warn of adverse side effects. So if, in the future, Actos and its generic counterpart are found to cause more than bladder cancer and cardiovascular concerns, you may sue Takeda Pharmaceuticals, but you may not have a defective drug claim against Mylan Pharmaceuticals. You should always speak with an experienced trial lawyer to be sure.

Earlier this year, a Cleveland investigative reporter interviewed partner Peter Brodhead about the Supreme Court’s decision. To view that segment – and to see how the decision has affected a few people in our community – please click here.

Only time will tell how the FDA’s decision to approve a generic version of Actos will affect pending lawsuits against Takeda Pharmaceuticals. In the meantime, be sure to speak with an Actos lawyer if you feel that you may have a case.