Depakote/Sodium Valproate to control agitation

[sharina]

I hope that everyone is aware of the latest news from America about this drug and the manufacturers.

This drug is a branded version of Sodium Valproate being it seems part Sodium Valproate and part Valporic acid. I am not sure if there is much difference between the two. I have read an article on it but it is a bit complicated to print. You can google the difference between the two online.

Anyhow,there was research done from about 1999 to early 2000's suggesting Depakote was useful as a drug to control agitation in dementia off licence.

However, according to news reports from America, it is alleged that Abbot Lab when they realised the drug was not reliably effective to control agitation in dementia still encouraged their Sales People to push the drug and suppressed negative results that established that the side effects/risks outweighed any perceived benefits.

Abbot have now incurred a more than a billion dollar penalty.
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In addition I have found the following advice that the use of sodium valproate is not supported to control agitation in dementia.

"An anticonvulsant called valproate is sometimes used to control agitation in people with dementia but current evidence does not support its use, with a recent review suggesting that it produces no improvements.
There is currently a need for more evidence about the effectiveness and safety of antidepressants and anticonvulsants in the treatment of behavioural and psychological symptoms in dementia. These drugs should not usually be combined with each other or with antipsychotics."


Factsheet 408
Last reviewed: January 2012
Next review due: January 2014

[sharina]

A US drug company has agreed to pay out $1.6bn (£1bn) after improperly marketing a mood-stabilising drug in a settlement thought to be the largest of its kind involving a single drug.

Abbott Laboratories encouraged its sales teams to market Depakote for uses that were not approved by regulators, the US justice department said.

The drug should be used in epilepsy and bipolar disorder cases.

However, it was sold to treat conditions such as dementia and autism.

According to a US justice department statement, Abbott maintained a specialised sales force to market the drug in nursing homes.

It said the drug could be used for the control of agitation in elderly dementia patients, despite the absence of any credible scientific evidence that Depakote was safe and effective for that use.

The illegal conduct was not the product of "some rogue sales representatives," US Attorney Timothy Heaphy said. The company engaged in the strategy from 1998 to at least 2006, he said.

Reuben Guttman, a lawyer who represented some of the company whistle-blowers, said that Abbott had preyed on two vulnerable categories of patient - the elderly and children.

The company "violated basic norms of health care and ethics", he said.

The company also marketed Depakote to treat schizophrenia, but clinical trials failed to demonstrate that the drug was any more effective than anti-psychotic drugs in treating the condition, according to court papers.

Abbott Laboratories will now pay $800m to federal and state governments, $700m in criminal penalties and a further $100m to resolve consumer protection issues.

The company has also agreed to a five-year probationary period to ensure that there is no repeat of the misconduct.

[sue38]

Thanks for highlighting this Sharina. You can read the BBC News report on the case here.