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Home , Quetiapine

Fact or Fiction

Is quetiapine effective for anxiety?

Jessica L. Gören, PharmD, BCPP, and Courtney Nemeth Wiseman, MD, MPH

Dr. Gören is Associate Professor, Department of Pharmacy Practice, he rate of off-label prescribing of generalized (GAD). University of Rhode Island, Kingston, second-generation Three trials that involved >2,100 pa- RI; Senior Clinical Pharmacist Specialist, Department of Pharmacy, Cambridge (SGAs) is estimated to have doubled tients found quetiapine XR monotherapy T 1,2 Health Alliance; and Instructor in the past decade. In 2010, quetiapine is effective for GAD in doses of 50 to 300 in Psychiatry, Harvard Medical was the most commonly used SGA in the mg/d.5-7 In 2 of the studies, quetiapine XR School, Boston, MA. Dr. Wiseman is Instructor, Clinical, Contributing United States with >10 million prescrip- was as effective as and esci- Services Faculty, Department of tions dispensed.2 Clinical experience and for GAD.5,6 Reviews of off-label Psychiatry and Behavioral Sciences, Feinberg School of Medicine, reports from patients indicate quetiapine SGA use have found that compared with Northwestern University, Chicago, IL. may be useful for treating anxiety. When placebo, quetiapine XR monotherapy is ef- making medication choices, it can be use- fective for GAD (number needed to treat ful to combine anecdotal evidence with the = 8).8,9 Side effects reported in clinical tri- facts (or lack thereof). Does evidence sup- als of quetiapine included headache, som- port or contradict the use of quetiapine for nolence, sedation, fatigue, dizziness, dry anxiety? mouth, weight gain, hyperlipidemia, and elevated glucose levels. What the research shows Quetiapine is FDA-approved for treating: What did the FDA say? • adults and adolescents with In April 2009, the FDA’s Psychopharma­ cologic Drugs Advisory Committee re- • adults, children, and adolescents with viewed whether evidence supported que- acute manic episodes associated with bipo- tiapine XR for treating MDD and GAD.10 lar I disorder (BDI) as monotherapy or as an Although the committee found that que- adjunct to or divalproex tiapine XR monotherapy effectively treated • adults with an acute depressive epi- GAD, it concluded it was not acceptably sode associated with safe.11 The committee expressed concerns • adjunctive treatment of major depres- over exposing a greatly expanded popula- sive disorder (MDD) in adults tion to a drug with substantial metabolic side • maintenance treatment of BDI as an ad- effects, including weight gain (incidence 3% junct to lithium or divalproex in adults.3 to 23%), increased cholesterol (incidence 7% In addition, quetiapine extended-release to 18%), and .12-14 Weight gain (XR) is approved as an adjunctive treatment and metabolic effects have been reported for MDD in adults.4 even when quetiapine is prescribed at low Neither the immediate-release or XR for- doses (≤100 mg/d).15,16 The FDA did not ap- mulation is indicated for treating anxiety, prove expanding the indication of quetiap- but quetiapine has been studied as a treat- ine XR to include treatment of GAD. ment for several anxiety disorders, including posttraumatic stress disorder, social phobia, Our opinion obsessive-compulsive disorder, and anxiety Quetiapine XR is effective for treating secondary to mood disorders. It has been GAD. However, even at low doses, it is as- Current Psychiatry E4 August 2012 most extensively studied as treatment for sociated with substantial side effects and should be reserved for patients with poor response or contraindications (eg, ) Related Resources to traditional GAD treatments such as se- • AstraZeneca. Seroquel prescribing information. www1. lective reuptake inhibitors and -us.com/pi/seroquel.pdf. • AstraZeneca. Seroquel XR prescribing information. www1. serotonin- reuptake inhibi- astrazeneca-us.com/pi/seroquelxr.pdf. tors. Published studies assessed quetiap- Drug Brand Names ine XR only when used on a scheduled ba- Divalproex • Depakote Paroxetine • Paxil sis, and did not address use of quetiapine • Lexapro Quetiapine • Seroquel immediate release or XR on an as-needed Lithium • Eskalith, Lithobid basis for GAD. Disclosure The authors report no financial relationship with any company Quetiapine is References whose products are mentioned in this article or with manufactur- 1. Alexander GC, Gallagher SA, Mascola A, et al. Increasing ers of competing products. effective for GAD off-label use of medications in the United States, 1995-2008. Pharmacoepidemiol Drug Saf. 2011;20(2): but side effects 177-184. 2. Drug Topics. 2010 Top 200 branded drugs by total limit its use as a prescriptions. http://drugtopics.modernmedicine.com/ http://www.fda.gov/AdvisoryCommittees/Calendar/ drugtopics/data/articlestandard/drugtopics/252011/ first-line agent for ucm136250.htm. Updated June 18, 2009. Accessed June 26, 727256/article.pdf. Published June 2011. Accessed June 26, 2012. 2012. treating anxiety 11. FDA advisory committee recommendation on Seroquel 3. Seroquel [package insert]. Wilmington, DE: AstraZeneca; XR supplemental new drug applications [news release]. 2012. Wilmington, DE: AstraZeneca; April 9, 2009. http://www. 4. Seroquel XR [package insert]. Wilmington, DE: AstraZeneca; astrazeneca.com/Media/Press-releases/Article/20090409-- 2012. FDA-Advisory-Committee-Recommendation-on-Seroquel- 5. Merideth C, Cutler A, Neijber A, et al. Efficacy and tolerability XR-. Accessed June 26, 2012. of extended release quetiapine fumarate monotherapy 12. Meyer JM, Koro CE. The effects of antipsychotic therapy on in the treatment of GAD. Eur Neuropsychopharmacol. serum lipids: a comprehensive review. Schizophr Res. 2004; 2008;18(suppl 4):S499-S500. 70(1):1-17. 6. Bandelow B, Chouinard G, Bobes J, et al. Extended- 13. Newcomer JW. Metabolic considerations in the use of release quetiapine fumarate (quetiapine XR): a once-daily antipsychotic medications: a review of recent evidence. J monotherapy effective in generalized anxiety disorder. Clin Psychiatry. 2007;68(suppl 1):20-27. Data from a randomized, double-blind, placebo- and 14. Chen WY, Chen CC, Hung GC. Hyperglycemic active-controlled study. Int J Neuropsychopharmacol. 2010; hyperosmolar state associated with low-dose quetiapine 13(3):305-320. treatment in a patient with bipolar disorder. Curr Drug Saf. 7. Katzman MA, Brawman-Mintzer O, Reyes EB, et al. 2011;6(3):207-208. Extended release quetiapine fumarate (quetiapine XR) 15. Williams SG, Alinejad NA, Williams JA, et al. Statistically monotherapy as maintenance treatment for generalized significant increase in weight caused by low-dose anxiety disorder: a long-term, randomized, placebo- quetiapine. Pharmacotherapy. 2010;30(10):1011-1015. controlled trial. Int Clin Psychopharmacol. 2011;26(1): 11-24. 16. Simon V, van Winkel R, De Hert M. Are weight gain and metabolic side effects of atypical antipsychotics dose 8. Maglione M, Ruelaz Maher A, Hu J, et al; Agency for dependent? A literature review. J Clin Psychiatry. 2009; Healthcare Research and Quality. Off-label use of atypical 70(7):1041-1050. antipsychotics: an update. http://www.effectivehealthcare. ahrq.gov/ehc/products/150/786/CER43_Off- LabelAntipsychotics_execsumm_20110928.pdf. Published September 2011. Accessed June 26, 2012. 9. Maher AR, Maglione M, Bagley S, et al. Efficacy and What is your experience? Do you agree with comparative effectiveness of medications for off-label uses in adults: a the authors? Send comments to letters@ and meta-analysis. JAMA. 2011;306(12):1359-1369. currentpsychiatry.com or share your thoughts on 10. U.S. Food and Drug Administration. Psychopharmacologic www.facebook.com/CurrentPsychiatry. Drugs Advisory Committee meeting announcement.

Current Psychiatry Vol. 11, No. 8 E5