What is Seroquel?

Seroquel is a brand name of Quetiapine Fumarate. Seroquel was approved by the FDA for the treatment of schizophrenia in patients 13 years old and older, to treat bipolar disorder in adults manic episodes associated with bipolar I disorder in children ages 10 to 17 years old.¹

Seroquel is sold by AstraZeneca.²

Does Seroquel it work?

In 1997, the same year the FDA approved Seroquel to treat schizophrenia, AstraZeneca suppressed the results of a long-term study of Seroquel which showed that Seroquel failed to outperform older drugs. A 2005 study of atypical antipsychotics (including Seroquel) showed that these drugs failed to outperform older antipsychotics, had no advantages over the older drugs and that the new drugs had very high discontinuation rates due to side effects.³

In 2010, Astra-Zeneca agreed to pay a $520 million fine to settle charges that it illegally marketed Seroquel for uses not approved as safe or effective by the FDA. AstraZeneca marketed Seroquel for the treatment of aggression, Alzheimer’s disease, anger management, anxiety, ADHD, dementia, depression, post-traumatic stress disorder and sleeplessness. The company specifically targeted groups of doctors that didn’t typically treat the conditions Seroquel had been approved for. The company recruited doctors to give promotional speaker programs promoting unapproved uses of Seroquel, and to serve as authors on articles ghost written by medical literature companies about studies those doctors did not conduct, and then used those studies and articles to promote unapproved uses of Seroquel. AstraZeneca paid those doctors illegal kickbacks to give lectures and act as authors of ghost-written articles promoting off-label uses of Seroquel.⁴

AstraZeneza paid at least one doctor many thousands of dollars, to serve as the author of papers he didn’t write, on studies he didn’t conduct and to present those studies and falsely favorable data on Seroquel to audiences at speaking engagements.⁵

What should I ask my doctor about before I decide to use Seroquel?

Like all anti-psychotics, Seroquel has many and very serious side effects. All atypical antipsychotics can cause a potentially fatal condition called Neuroleptic Malignant Syndrome, which can cause irregular heart rhythms and kidney failure. Seroquel and other anti-psychotics also cause a nervous system disorder called tardive dyskinesia, which causes people to make involuntary and repetitive body movements such as grimacing facial expressions, movements of the lips and tongue or rapid blinking and sometimes movements of the torso, limbs or hands that they can’t control and sometimes grunting or difficulty breathing. Other serious side effects of Seroquel can include hyperglycemia (high level of glucose in blood but lower than diabetes), diabetes, cataracts, seizures and other serious conditions. Seroquel and other antipsychotics are particularly dangerous for elderly patients and can lead to aspiration pneumonia, which is a common cause of death in elderly patients.⁶

Seroquel also causes significant excessive weight gain, which can be a factor in the development of Type 2 Diabetes. AstraZeneca suppressed public release of studies which showed unfavorable results, including that more than 80 of participants in some studies on Seroquel quit due to adverse side effects.⁷

What if I’m already taking Seroquel?

Never stop taking any prescription medication without discussing it with your doctor. If you experience any adverse effects or side effects, tell your doctor as soon as possible. Be sure to tell your doctor any other medication you are taking and discuss medications that should not be taken with Seroquel, including over-the-counter medications.⁸

If you have been taking Seroquel and stop, you may experience withdrawal symptoms, which doctors sometimes call “discontinuation syndrome.” These symptoms can include nausea, vomiting, dizziness, headache, severe anxiety, insomnia, diarrhea, shaking and other symptoms. Your doctor can help you develop a plan to taper off Seroquel gradually and reduce these symptoms.⁹

Learn everything that you can about Seroquel before you start taking it.

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¹ Food and Drug Administration, Medication Guide Seroquel, (2011), http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf
² http://www.seroquelxr.com/
³ Washington Post, Vedantam S., “A Silenced Drug Study Creates An Uproar” (18 March 2009), http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html
⁴ United States Department of Justice, “Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing” (27 April 2010), http://www.justice.gov/opa/pr/2010/April/10-civ-487.html
⁵ City Pages, Mannix A., “Charles Schulz under scrutiny for Seroquel study suicide” (2 February 2011) http://www.citypages.com/2011-02-02/news/charles-schulz-under-scrutiny-for-seroquel-study-suicide
⁶ Food and Drug Administration, Seroquel labelling information (retrieved 20 October 2012), http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf
⁷ Washington Post, Vedantam S., “A Silenced Drug Study Creates An Uproar” (18 March 2009), http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html
⁸ Ibid.
⁹ Am J Psychiatry, Kim D et al, “Quetiapine Discontinuation Syndrome” (1 May 2005), http://ajp.psychiatryonline.org/article.aspx?articleid=177544; Psych Central, Patient Forums (retrieved 20 October 2012), http://forums.psychcentral.com/archive/index.php/t-45595.html; topix.com, Forums (retrieved 20 October 2012), http://www.topix.com/forum/drug/seroquel/T1G6E60LQHIT5DCMV