Popular Drug Reveals the Issue of “Off-Label” Use

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From The Washington Post: Despite major lawsuits and detailed reports pertaining to severe health risks associated with the antipsychotic Seroquel, the drug remains one of the country’s most popular drugs and is increasingly prescribed “off-label” for insomnia, anxiety, and PTSD.

“A Washington Post analysis of more than four years of the most recent data from the FDA’s Adverse Event Reporting System — through the first quarter of 2017 — found about 20,000 cases where Seroquel or its generic equivalent, quetiapine, was listed as the primary or secondary suspect in an adverse event. That included 1,754 deaths in which they were the primary suspect plus 2,309 deaths in which they were a secondary suspect. Overall, 93 percent were apparently the result of off-label prescribing of the drug.

Earlier data, analyzed by the nonprofit Institute for Safe Medication Practices, looked at adverse events by category of quetiapine use and found that off-label prescribing accounted for more than a quarter of 5,657 cases from 2004 through September 2010. More than half of the off-label cases were for insomnia and sleep disorders.”

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7 COMMENTS

  1. I am pleased to learn of this Washington Post article highlighting the off-label use of seroquel/quetiapine, particularly for sleep. I see it all the time in the clinic. I know a child psychiatrist who hands out quetiapine like candy to young teenagers. About 1/3 of the clients referred to me by psychiatrists are taking this drug and have not been informed about the possible adverse effects, lack of scientifically established benefits for sleep, and expert recommendations not to use it for sleep (http://www.ndshp.org/Resources/Documents/Quetiapine.pdf). My clients typically say the drug knocks them out at night and that they awake feeling tired, groggy, and cognitively impaired, and that these effects take hours to wear off. Failure to provide even basic information to clients about established risks and benefits of a drug is an ethical violation yet appears to be standard practice. My experience in the clinic is consistent with Chaya Grossberg’s lesson learned #1 (https://www.madinamerica.com/2018/03/10-things-learned-people-coming-off-psych-drugs/): “No one gets on psychiatric drugs with informed consent.”

  2. I was prescribed 25mg of Seroquel per day in 2005. I found 25mg (the lowest dose), a bit strong so I cut down to 1/4 of this. At night I used to take it maybe 15 minutes before sleeping and sometimes I nearly collapsed before I got to bed.

    After some time I noticed on waking that my chest area was a soft red, and the rest of me completely white. I also noticed worrying heart beat drops. So I stopped the Seroquel and my chest colour returned to normal; and the drops on heart beats stopped. But my sleeping dropped as well from up to 9 hrs per night to 4 to 5 hrs. (and after many years it’s still not great). But at least I’m still alive!

  3. I believe Seroquel has a Black Box Warning attached to it in the USA.

    If a doctor doesn’t record heart rythm problems then they don’t exist, and a middle aged overweight person having a heart attack is not too out of the ordinary A lot of potential drug deaths could be going unnoticed.

  4. Just to remind ourselves, the studies seem to show that Seroquel is not even a very good anti-psychotic. Its effect size varies depending on who studied it from 0.33 (Hutton, Moncrieff et al) to 0.44 (Leucht/Cipriani et al). Looking at whether that effect actually makes anyone feel better, the Number Needed To Treat is 21 and 16 respectively and its only 8-10 for antidepressants. So since antidepressants are useless, Quetiapine is either a little bit above useless or possibly worse than useless.