FDA Rejects New Diabetes Drug That Contains Actos
A new drug developed by manufacturer Takeda Pharmaceuticals to replace the controversial diabetes drug Actos has been rejected by the FDA. The new drug combines Actos with another drug. The FDA has ordered Takeda to produce more evidence showing “how the drugs have performed in other countries where they have already been approved.”
Injured plaintiffs consult an Actos lawyer
Actos has come under fire due to lawsuits filed by diabetes patients who allegedly developed Actos bladder cancer after taking the drug. In fact, Actos was banned in some European countries that deemed the risk of developing Actos bladder cancer too great. Diabetes patients who believe they may have developed Actos cancer have consulted an Actos lawyer for guidance in the legal process.
Takeda is looking to replace Actos by the time its patent expires in about four months, at which time companies will be able to make generic versions of the drug, cutting into Takeda’s profits. Despite the accusations of negligence made by Actos cancer plaintiffs, Takeda has shown no signs of taking the drug off the market in America.
Actos, already taken off the market by French and German regulators, represents a major part of Takeda’s profits, which have fallen significantly in response to growing numbers of Actos lawsuit filings. In many of these suits, the plaintiff’s Actos lawyer complains that Takeda ignored evidence of the bladder cancer risk in order to keep making money off of the drug. Complaints of Actos cancer and other adverse events associated with the drug, like macular edema (which causes blindness), helped cause sales of the drug to fall 13% between March and September 2011.
Actos side effects lawsuits in Louisiana
Takeda will go to court in lawsuits consolidated into multidistrict litigation (MDL) in Louisiana, under Judge Rebecca Doherty. In the MDL, each Actos lawsuit will have a separate trial, but pre-trial discovery will occur simultaneously, conserving resources for each plaintiff and their Actos lawyer.
Eli Lilly & Co. is also named in the MDL as a co-defendant. Together, the companies face allegations that they failed to sufficiently warn diabetes patients of the risk of developing Actos cancer. A select few Actos cases will be chosen for bellwether trials, which are expected to predict what compensation plaintiffs will receive for their Actos side effects.