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Study Finds Drop in Use of Antipsychotics for Dementia After Black Box Warning

By February 16, 2011July 18th, 2019Dangerous Drugs

As a defective prescription drug attorney, I’ve written before about the possible misuse of antipsychotic drugs in patients with dementia. This practice is popular because dementia patients can suffer delusions, paranoia, aggression and agitation, sometimes making them a danger to themselves and others. Starting in the early 2000s, caregivers began responding by giving patients atypical antipsychotics such as Risperdal (risperidone) and Zyprexa (olanzapine), an off-label use of the drug but a common one. However, studies increasingly began showing that these newer antipsychotics carried an increased risk of death in the elderly. In response, the FDA added a black box warning, its strongest, to the packaging of the drugs in 2005. Now, a new study shows that prescribing took a sharp downturn after that black box warning.
Difficult-to-control dementia patients demand a lot of time from caregivers, and thus a lot of money from nursing homes and other facilities. That’s why it was once more popular to prescribe atypical antipsychotics to keep dementia patients calm, even though the FDA hadn’t approved the drugs for this purpose. But after a series of studies in the early 2000s, scientists concluded that patients on those drugs were substantially more likely to die than similar patients not using the drugs – in one Canadian study, 31 to 55 percent more likely. Deaths were particularly blamed on stroke and cardiovascular causes, including diabetes.
The new study in the Archives of General Psychiatry used Veterans Affairs data to conclude that new prescriptions for all types of antipsychotics dropped from 18% of dementia patients in 1999 to 12 percent in 2007. That study found that first-generation antipsychotic use dropped throughout the study period, while atypical antipsychotic use rose until 2003 – when the medical community first reported the risk of death in the elderly. In 2003, atypical antipsychotic use began to drop – and 2005, after the black box warning, it accelerated. Another study of prescribing practices at doctors’ offices found a 50 percent reduction in antipsychotic use between 2004 and 2008.
As a dangerous prescription drug lawyer, I’m pleased to see such a strong correlation between regulatory action and changes in prescribing practices. I am particularly interested in the fact that prescriptions started dropping when the risk of death from atypical antipsychotics first became known – but dropped much faster once the FDA added a black box warning to the drug. That suggests that doctors take the FDA’s warnings seriously. That’s good in itself, and it also shows that regulatory actions likely do matter. Unfortunately, the FDA moves slowly – it frequently waits months for panels to make nonbinding decisions before taking action. Since some scientific decision-making can’t be sped up, it would be best if more doctors were willing to change their prescribing practices as soon as credible scientific evidence about a drug appeared.

Based in St. Louis, Carey, Danis & Lowe focuses its practice on representing families that have suffered an injury, illness or death because of a defective prescription drug. When doctors give us drugs, we trust that the drugs will help us feel better. But when the drugs have a serious safety problem, they can actually hurt patients further. And when drug companies know about the problem, but fail to warn the public or even try to hide it, they can be legally responsible for all of the injuries and illnesses that result. Our pharmaceutical liability attorneys help patients collect financial damages after they were hurt by a drug they thought they could trust. That includes money for all current and future medical costs, as well as compensation for an illness, an injury or any permanent disability or death.
If your family was hurt because of a pharmaceutical and you believe the manufacturer should have warned you, you should call Carey, Danis & Lowe for help. To set up a free consultation, send us a message online or call 1-877-678-3400 today.