A US judge fined Johnson & Johnson and a subsidiary more than $US1.1 billion ($1.07 billion) today for downplaying and concealing risks associated with the anti-psychotic drug Risperdal, The Herald Sun reported.
This came after a jury in Arkansas found that the companies “minimised or concealed the dangers associated with an antipsychotic drug,” notably diabetes and weight gain.
The Department of Health and Ageing in Australia said they have taken this case into account when considering the benefit-risk ratio for Risperdal.
“In Australia the important product Information document for Risperdal, on which doctors rely, clearly warns of the increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar,” said a spokesperson for the Therapeutic Goods Administration (TGA).
“It is then up to doctors, who in Australia have this full information, to consider the risks of treatment and the anticipated benefits of that treatment and entail informed consent. “
Risperdal, introduced in 1994, is a “second-generation” antipsychotic drug that earned Johnson & Johnson billions of dollars in sales before generic versions became available several years ago.
The US Food and Drug Administration in 2004 forced the company to revise the drug’s labelling to reflect increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.
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