Do you need a reason for a thorough and transparent pharmacovigilance process… how about nine billion reasons?
A US court has slapped Takeda and Eli Lilly with record damages of $9 billion for failure to warn patients of the link between its diabetes drug, Actos (pioglitazone), and bladder cancer. Takeda was fined $6 billion and Eli Lilly, who marketed the drug in the US between 1999 and 2006, was fined $3 billion.
In the case, a former Actos user claimed to have developed bladder cancer after using the drug for more than five years. The suit claimed that Takeda downplayed the increase in bladder cancer risk associated with Actos and misled regulators about the dangers.
A bladder-cancer warning was added to the Actos label in 2011, to reflect the finding that using Actos for more than a year could increase the risk of bladder cancer by 40%. Since then, thousands of patients have sued both Takeda and Eli Lilly. Germany and France suspended the medicine the same year.
The prescribing information for the drug lists several serious potential side effects – congestive heart failure being at the top of the list. Bladder cancer is fourth on the list, beneath the risks of hypoglycaemia and liver damage.
At one point, Actos was Takeda's top-selling medicine, but sales have plunged due to competition from generic drugs and fears over its link with bladder cancer. Both Takeda and Eli Lilly have said they intend to contest the ruling by every available legal means.
www.whitehalltraining.com
Whitehall Training provides pharmacovigilance training courses that cover all aspects from signal detection and reporting to international regulation. The 4-module format allows learers to tailor the learning to suit the needs of their specific role.
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