Quetiapine: the legal and safety record

The 2010 resolution, stated precisely

On April 27, 2010, AstraZeneca agreed to pay $520 million to resolve allegations that, from 2001 to 2006, it promoted Seroquel for uses the FDA never approved — insomnia, aggression, anxiety among them — and aimed that promotion at primary care physicians, pediatricians and geriatricians, prescribers who, in the government’s words, do not typically treat schizophrenia or bipolar disorder [1]. Three facts keep this page honest. It was civil-only — no criminal charge, no plea, unlike the Zyprexa and Paxil cases elsewhere in this series. A civil settlement resolves allegations without a determination of liability. And it was about marketing, not about whether the drug injured anyone. (An earlier version of this page added that news coverage called it the largest civil-only off-label settlement to that date. That superlative is not in the Justice Department’s release, so we removed it.)

Why it still matters: the sleep prescription

The reason this sixteen-year-old case earns a page is continuity: low-dose quetiapine for insomnia — the marquee use in the allegations — remains one of the most common off-label psychiatric prescriptions in America. Quetiapine filled 8.7 million US prescriptions in 2024 [3]; public data cannot say what share is for sleep, and this page will not guess. What it can say: the use was never approved, the marketing that helped build it was the subject of a half-billion-dollar settlement, and the metabolic side-effect profile that makes an antipsychotic a heavy tool for insomnia is on our quetiapine page with the label quoted verbatim.

The sleep prescription, measured

Nobody records why a prescription was written, but dose is a clue. In two state Medicaid programs, 53 to 56 percent of people starting a newer antipsychotic started at a low dose, and quetiapine was the most common drug; low-dose quetiapine starts fell in Oregon after off-label promotional activities were suspended [5]. The trial evidence for insomnia is one randomised trial of 13 patients, with no significant benefit over placebo [6]. In Denmark, people started on low-dose quetiapine had more heart attacks, strokes and cardiovascular deaths than people started on ordinary sleeping pills, an observational finding that others dispute [7]. The federal VA and Defense Department guideline for chronic insomnia suggests against antipsychotics [8]. None of that makes a given prescription wrong; it is why “what is this for, and what else was tried?” is the question to ask.

What is not in the record

• No criminal plea, no admission. Writing “found guilty” about this case is wrong in a checkable way [1].
• No adjudicated injury finding. AstraZeneca’s SEC filings report agreements in principle with lawyers for 28,575 metabolic personal-injury claimants by January 2012, on confidential terms, and a defense verdict in the one case tried; no court decided causation [4]. An earlier version of this page gave a settlement total of about $647 million, taken from a news report. No AstraZeneca filing states a total, so we removed it.
• No Class I recall — twelve records, all Class II/III, within openFDA's ~2012-onward coverage window [2].

Common questions

What did AstraZeneca pay $520 million for?

To resolve civil allegations, announced April 27, 2010, that between 2001 and 2006 it promoted Seroquel for uses the FDA never approved — insomnia, aggression, anxiety and others — and marketed it to primary care physicians, pediatricians and geriatricians, prescribers who do not typically treat schizophrenia or bipolar disorder. There was no criminal charge, no plea, and no determination of liability: a civil settlement resolves allegations, and precision about that is the difference between reporting and overclaiming.

Is quetiapine approved for insomnia?

No. It is approved for schizophrenia and bipolar indications and as an adjunct in major depression. Low-dose quetiapine for sleep is off-label — legal to prescribe, heavily prescribed, and the exact use the 2010 allegations said was being promoted. The evidence question for a sleep prescription is therefore the one to ask: what trials support this dose for this use, against alternatives with far lighter metabolic baggage?

Was anyone found liable for Seroquel injuries?

The federal resolution was about marketing conduct, not injuries, and adjudicated no harm to any patient. Separate personal-injury litigation over diabetes and metabolic effects was resolved in court-ordered mediation: by January 31, 2012, AstraZeneca reported agreements in principle with lawyers for 28,575 claimants, on terms it says are confidential, and it has never published a total. The one case that reached a jury ended in a defense verdict for AstraZeneca. No court decided causation.

Has quetiapine had serious recalls?

No Class I recall — FDA’s most serious category — appears in the openFDA enforcement database (openFDA enforcement data is reliable only from roughly 2012 onward, so this is a statement about the covered window, not the drug’s whole history). Twelve records exist, eight Class II and four Class III, for manufacturing and quality issues rather than anything about the molecule.

Should I stop taking quetiapine because of this history?

No — not on your own, and for an antipsychotic the stakes of abrupt stopping are high. What the record sharpens is a question, not a decision: if the prescription is low-dose for sleep, ask what the evidence for that use is and whether weight, glucose and lipids are being monitored. If it is for schizophrenia or bipolar disorder, this page changes nothing about a treatment that has approval-grade evidence behind it.

Sources

Last verified 2026-09-29. Corrections change this date.