Sda112011.qxp

Antidepressant/Warfarin Interaction .81
Beta-Blockers for Violence Prevention.87
Bupropion vs Paroxetine for Suicidality .83
PSYCHIATRY Clozapine and Eosinophilia.86
Generic Olanzapine.81
IM Haloperidol: Needle Length.82
DRUG ALERTS Quetiapine QT Prolongation.86
Reference Guide .88
Therapeutic Drug Monitoring.84
Varenicline Safety Update .82
Zonisamide Augmentation.85
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Generic Olanzapine Approved
The FDA has approved the first generic versions of Zyprexa (olanzapine) and Zyprexa Zydis(olanzapine orally disintegrating tablets) for the treatment of schizophrenia and bipolardisorder. The generic versions have the same quality, strength, and purity as the brand-nameagents, and the manufacturing, packaging, and testing sites must meet the same quality stan-dards. Generic olanzapine tablets will be manufactured by Dr. Reddy’s Laboratories and TevaPharmaceuticals, and the Zydis formulation will be manufactured by Apotex, Dr. Reddy’sLaboratories, and Par Pharmaceuticals.
FDA News Release: FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder. Available atwww.fda.gov/NewsEvents/Newsroom/PressAnnouncements.
Antidepressant/Warfarin and GI Bleeding
According to results of a case-control study, patients receiving chronic warfarin therapy havean increased risk of GI bleeding after receiving a new prescription for an antidepressant. Theexcess risk appears to decline with subsequent prescriptions.
Methods: Medicaid enrollees from 5 large U.S. states, which account for about one-third of
the country’s Medicaid population, comprised the study sample. Case patients were those
prescribed warfarin between 1999 and 2005 who were hospitalized for GI bleeding during
this period. Each case was matched with 50 controls (warfarin users who did not experience
GI bleeding). The analysis included only antidepressants initially prescribed after a period of
warfarin use. All antidepressants, regardless of drug class, were considered if they were
listed as potentially interacting agents with warfarin in commonly used U.S. drug-interaction
compendia.
Results: The incidence of hospitalization for GI bleeding in the entire patient population was
about 4.5 per 100 person-years of warfarin use. Of the 9 antidepressants, all but nortriptyline
PSYCHIATRY DRUG ALERTS (ISSN 0894-4873) is published monthly by M.J. Powers & Co. Publishers, 65 Madison Ave.,
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were associated with a statistically significant risk of GI bleeding, with odds ratios* rangingfrom 1.51 to 2.49. In an analysis adjusted for multiple factors (e.g., age; gender; nursing home placement; concomitant illness; use of acetaminophen, levofloxacin, or proton pumpinhibitors), the associations with escitalopram, sertraline, and venlafaxine were no longerstatistically significant, although all still had elevated odds ratios. The association with GI bleeding remained statistically significant for citalopram, fluoxetine, paroxetine,amitriptyline, and mirtazapine. Citalopram and mirtazapine had the highest odds ratios inthe adjusted analysis, at about 1.7. The excess risk of GI bleeding was associated only withthe first prescription for an antidepressant and did not extend to second, third, and fourthprescriptions.
Discussion: Depression often coexists with cardiovascular disease. About 7% of patients
using warfarin are also given a prescription for antidepressants, which can interact with
warfarin by interfering with its metabolism and by blocking serotonin reuptake by platelets.
Previous studies of bleeding risk have had conflicting results, possibly because investigators
assumed that bleeding risk would be constant after introduction of the antidepressant. The
present study assumed that risk would be limited to the early period because susceptible
patients would develop GI bleeding soon after antidepressants were prescribed and then
discontinue treatment or change the antidepressant.
Schelleman H, Brensinger C, Bilker W, Hennessy S: Antidepressant-warfarin interaction and associated gastrointestinal
bleeding risk in a case-control study. PLOS One 2011;6(6):e21447. From the University of Pennsylvania, Philadelphia.
Funded by the National Institute on Aging. The study authors disclosed financial relationships with commercial
sources.
Drug Trade Names: amitriptyline—Elavil, Endep, Enovil; citalopram—Celexa; escitalopram—Lexapro;
fluoxetine—Prozac; levofloxacin—Levaquin; mirtazapine—Remeron; nortriptyline—Aventyl, Pamelor;
paroxetine—Paxil; sertraline—Zoloft; venlafaxine—Effexor
*See Reference Guide.
Varenicline Neuropsychiatric Safety Update
In 2007 the FDA issued a warning about suicidal thoughts and aggressive behavior inpatients using varenicline (Chantix) for smoking cessation. In 2008 another report suggestedthe neuropsychiatric symptoms were likely associated with the drug rather than with nico-tine withdrawal. Since that time, 2 FDA-sponsored epidemiological studies have examinedthe neuropsychiatric adverse effects of varenicline in patients trying to quit smoking. Neitherstudy found a significant difference in serious neuropsychiatric events (i.e., that requiredhospitalization) between varenicline and nicotine-replacement therapies such as NicoDermpatches. These studies had serious limitations, including small samples and only evaluatingevents that precipitated hospitalization. The manufacturer is currently conducting a large-scale study to evaluate the neuropsychiatric safety of varenicline. The results are expected in 2017. Until then, prescribers are urged to monitor patients who are taking the drug foragitation, depressed mood, behavioral changes, and suicidal thoughts.
FDA drug safety communication: safety review update of Chantix (varenicline) and risk of neuropsychiatric adverseevents. Available at www.fda.gov/Drugs/DrugSafety/ucm276737.htm.
IM Haloperidol: Needle Length Matters
Intramuscular antipsychotic administration increases compliance and can improve relapseprevention efforts as well as reduce hospitalization. If the expected results are not beingobserved with IM administration, the effects of patient-specific characteristics, such asadiposity in the administration area, should be evaluated. In patients with prominent dis-tribution of adipose tissue, increasing needle length may improve medication effects. A 23-year-old female with schizophrenia had been treated with consecutive trials of IMhaloperidol and fluphenazine with minimal success and was subsequently lost to follow-up.
When she presented with continual auditory hallucinations and paranoid delusions, treat-ment was restarted with 5 mg b.i.d. oral haloperidol and monthly 150-mg IM glutealinjections of haloperidol decanoate using a 1.5-inch needle. Because of continued psychosis,the haloperidol decanoate dosage was increased to 350 mg administered every 3 weeks. Thepatient continued to experience auditory hallucinations. Excess gluteal fat distribution wasconsidered as a possible factor in this patient’s nonresponse. Following a switch to a 2-inchneedle, the patient noticeably improved and her improvement progressed.
The prescribing information for haloperidol decanoate includes instructions for needlegauge, but not length. Other IM antipsychotic labels include instructions regarding needlegauge and length based on administration site and patient weight. Generally, longer needlelengths are recommended for gluteal injections in patients with obesity.
Brahm N, Washington N: Case report: increased patient response to intramuscular haloperidol decanoate following a
change in needle length. Journal of Pharmacy Practice 2011;doi 10.1177/0897190011426559. From the University of
Oklahoma, Tulsa. The authors disclosed no competing interests.
Drug Trade Names: fluphenazine—Prolixin; haloperidol—Haldol
Bupropion vs Paroxetine for Suicidal Behavior
Results of a pilot study suggest paroxetine may be modestly superior to bupropion atreducing suicidal ideation in a subgroup of high-risk adults with depression. Patients withthe most severe suicidal ideation at baseline appeared to experience the greatest improve-ment with paroxetine.
Methods: Study subjects were 74 patients with a current major depressive episode and a
past suicide attempt, current suicidal ideation, or both. Patients received flexible-dose
extended-release paroxetine (starting at 25 mg/day, increasing to 37.5–50 mg/day) or
bupropion (starting at 150 mg/day, increasing to 300–450 mg/day). Treatment outcomes
were evaluated weekly for 8 weeks of acute treatment, followed by monthly evaluations for
an additional 16 weeks. Suicidal behavior during follow-up was assessed with the Clinical
Scale for Suicidal Ideation.
Results: A total of 24 patients (32%) did not complete acute treatment, and only 21 finished
the full 24-week protocol. During the study period, there were 10 suicidal events: 4 in the
paroxetine group and 6 in the bupropion group (3 of these events occurred in a single
patient). Most of the events (n=9) comprised increased ideation or agitation. A single patient
was hospitalized for an acetaminophen overdose.
Overall, improvements in suicidal ideation and depression did not differ substantiallybetween the groups. However, paroxetine produced greater improvements than bupropionin depression among patients with more severe depressive symptoms (other than suici-dality) at baseline. Similarly, improvements in suicidal ideation were greater with paroxetinethan with bupropion in these patients. Among those with the most severe suicidal ideationat baseline, bupropion was associated with a nearly 6-times greater risk than paroxetine ofworsening ideation.
Discussion: It appears that there have been no antidepressant clinical trials previously
conducted in patients chosen for elevated suicide risk. Suicidal behavior is known to be
associated with serotonergic hypofunction, but studies comparing serotonergic with nor-
adrenergic antidepressants have not consistently favored either drug class. Although the
high attrition rate and large variability in treatment outcomes limit the ability of this study to assess a selective effect of an SSRI on suicidal behavior, results suggest a larger clinicaltrial is warranted.
Study Rating*—17 (100%): This study met all criteria for a randomized clinical trial.
Grunebaum M, Ellis S, Duan N, Burke A, et al: Pilot randomized clinical trial of an SSRI vs bupropion: effects on
suicidal behavior, ideation, and mood in major depression. Neuropsychopharmacology 2011; doi 10.1038/npp.2011.247.
From Columbia University and New York State Psychiatric Institute, New York, N.Y. Funded by the National Alliance
for Research on Schizophrenia and Depression; and the NIMH.
Drug Trade Names: bupropion—Wellbutrin; paroxetine—Paxil
*See Reference Guide.
Therapeutic Drug Monitoring in Psychiatry
With the vast number of psychoactive drugs available today, therapeutic drug monitoring(TDM; the quantification of serum or plasma concentrations of medications for dose opti-mization) can be a valuable tool foroptimizing drug dosages. In 2004 Reference Ranges for Psychoactive Drugs for Which
TDM is Strongly Recommended
Drug Name
Therapeutic Reference Range
time, knowledge of TDM and pharma-cogenetics has advanced substantially, Antidepressants
evaluated, TDM was "strongly recom-mended" for 15, "recommended" for 52, Desipramine considered "useful" for 44, and "poten- tially useful" for 19. See table for TDMreference ranges for several commonly Antipsychotics
most TCAs, but is of little use for mostSSRIs, except in elderly patients for whom it may help determine aminimum effective dosage. Early plasma concentrations of citaloprammay be useful in predicting later nonresponse. Evidence does notsupport TDM for tetracyclic antide- recommended for the first-generationantipsychotics haloperidol, perphenazine, and fluphenazine, andthe second-generation agents amisul- Mood Stabilizers
risperidone. Therapeutic ranges arewell defined for lithium, valproic acid, and carbamazepine, and TDM isstrongly recommended for these drugs. For antidementia drugs (e.g., donepezil, rivastigmine) and anxiolytic/hypnotic drugs (e.g., benzodiazepines), TDM is rarely used but may be useful. Calculated therapeutic refer-ence ranges are scarce for dopamine agonists and other antiparkinsonian drugs, and theefficacy of TDM has not been established. TDM recommendations are also based on patient-specific factors. It is strongly recom-mended for pregnant or breastfeeding patients, children and adolescents, patients withintellectual disabilities, and the elderly. Plasma measurements can also be useful for: doseoptimization; suspected complete or partial-medication noncompliance; when there is a lackof improvement with recommended doses; if adverse effects occur; with a suspected druginteraction; for relapse prevention with maintenance treatment; in the presence of a particu-larity concerning genetic polymorphism; and for patients with pharmacokinetically relevantcomorbidities (e.g., hepatic or renal insufficiency, cardiovascular disease). Because concen-trations outside of the reference range may be caused by genetic polymorphisms, pharmaco-genetic studies may also be undertaken to determine if a patient is a "poor" or "ultrarapid"metabolizer, which can guide dosing decisions.
Hiemke C, Baumann P, Conca A, Dietmaier O, et al: AGNP consensus guidelines for therapeutic drug monitoring in
psychiatry: update 2011. Pharmacopsychiatry 2001; 44:195–235. From University Medical Center, Mainz, Germany; and
other institutions. Source of funding not stated. Several study authors disclosed financial relationships with
commercial sources.
Drug Trade Names: amisulpride (not available in the U.S.)—Deniban, Solian; amitriptyline—Elavil, and others;
carbamazepine—Epitol, Tegretol; citalopram—Celexa; clomipramine—Anafranil; clozapine—Clozaril;
desipramine—Norpramin; donepezil—Aricept; fluphenazine—Prolixin; haloperidol—Haldol;
imipramine—Tofranil; nortriptyline—Aventyl, Pamelor; olanzapine—Zyprexa; perphenazine—Trilafon;
risperidone—Risperdal; rivastigmine—Exelon; valproic acid—Depakene, Depakote
Antidepressant Augmentation with Zonisamide
In a pilot study, zonisamide showed promise as augmentation therapy in patients withunipolar major depression receiving duloxetine.
Background: Zonisamide is FDA approved as an anticonvulsant and is commonly used to
augment antiparkinsonian drugs. It has the ability to enhance dopaminergic and serotonergic
neurotransmission. In the present open-label, uncontrolled study, its use was investigated as
an adjunct to duloxetine, chosen because the 2 agents have little potential for pharmacoki-
netic interaction.
Methods: Study participants were 40 adults experiencing a major depressive episode. All
patients were initially treated with 60 mg/day duloxetine for 12 weeks. Those who did not
achieve clinical response (i.e., ≥50% reduction in the 17-item Hamilton Rating Scale for
Depression [HAM-D] total score) went on to receive 75 mg/day zonisamide, in addition to
their duloxetine, for another 12 weeks.
Results: After the initial 12 weeks, 15 patients had responded to duloxetine and 1 dropped
out of the study. Of the remaining 24 patients who received zonisamide augmentation, 14
achieved response by week 24. Thus by study end, 29 of 40 patients (73%) had responded to
either duloxetine or the combination.
Adverse effects were reported at 12 weeks and then at 24 weeks in the patients who went on to receive the zonisamide. During duloxetine monotherapy, some adverse effects—anorgasmia, poor concentration, and general malaise—were reported more commonly innonresponders than responders. During the 12-week augmentation period, insomnia wasthe only adverse effect reported by patients who had an antidepressant response. Among the 10 nonresponders to augmentation, poor concentration and reduced energy were reported by all, loss of libido by 8, and anorgasmia by 6. No patient had a manic episode.
Unexpectedly, patients who received zonisamide experienced significant weight lossbetween weeks 12 and 24, averaging >6 lbs in those with an antidepressant response and 3 lbs in nonresponders.
Discussion: Although the study had important methodological limitations, including the
small sample size, low duloxetine dose, and particularly the lack of a placebo control, the
results indicate that zonisamide may be an acceptable augmentation strategy in patients
with major depression. Further studies with rigorous designs are warranted before
definitive conclusions can be drawn.
Fornaro M, Martino M, Dalmasso B, Colicchio S, et al: An open pilot study of zonisamide augmentation in major
depressive patients not responding to a low dose trial with duloxetine: preliminary results on tolerability and clinical
effects. Annals of General Psychiatry 2011;10:23. From the University of Genova, Genoa, Italy; and other institutions.
Source of funding not stated. The authors disclosed no competing interests.
Drug Trade Names: duloxetine—Cymbalta; zonisamide—Zonegra
Quetiapine and QT Prolongation
The FDA recently required the addition of a warning about QT-interval prolongation, which can lead to torsades de pointes, to the labeling for quetiapine (Seroquel). The warningstemmed from reports of QT prolongation in patients with concomitant illness, those whowere taking other medications that affect the QT interval or cause electrolyte imbalance, and in cases of overdose. Several drugs are listed in the quetiapine labeling as concomitantmedications to avoid: the antiarrhythmics procainamide, quinidine, amiodarone, and sotalol,and the antibiotic moxifloxacin as well as chlorpromazine, thioridazine, and ziprasidone. QTprolongations are more likely to occur with increasing doses and in patients with elevatedserum concentrations because of renal or hepatic insufficiency. Resulting torsades de pointesoccurs more frequently in women and the elderly than in other populations. Other second-generation antipsychotics also have the potential to prolong the QT interval. Risk appears to belowest with aripiprazole and lurasidone, which may be better options for patients taking otherQT affecting drugs or at increased risk of complications from the prolongation. Quetiapine (Seroquel) and QT-interval prolongation. The Medical Letter 2011;53 (October 3):79.
Drug Trade Names: amiodarone—Cordarone, Pacerone; aripiprazole—Abilify; chlorpromazine—Thorazine;
lurasidone—Latuda; moxifloxacin—Avelox; procainamide—Procanbid, Pronestyl; quetiapine—Seroquel;
quinidine—Quinidex, and others; sotalol—Betapace, Sorine; thioridazine—Mellaril; ziprasidone—Geodon
Clozapine-Associated Benign Eosinophilia
A 27-year-old male had an 8-year history of paranoid schizophrenia for which he had beenhospitalized several times. Multiple antipsychotic trials produced little or no improvement.
Treatment with clozapine produced notable improvement in both positive and negative symp-toms within days, but tachycardia, fever, and eosinophilia developed over the first few weeksof treatment. Clozapine was replaced with relatively high-dose haloperidol, olanzapine, andaripiprazole. Psychotic symptoms improved, but the patient remained markedly impaired,both functionally and socially. When the patient’s condition deteriorated, clozapine rechallengewas considered, and a slow dose titration was started. Other psychotropics were tapered anddiscontinued, and the patient was monitored with near daily blood draws. Clozapine wastitrated in ≤25-mg increments every few days. Psychotic symptoms improved, but the patient’seosinophil count gradually increased to 13% of the total white blood cell (WBC) count. Therewere no cardiac symptoms or fever, other laboratory values were within acceptable ranges, andthe patient did not exhibit signs of organ involvement. Eosinophilia reached a peak of 16% of the total WBC count at a clozapine dosage of 150 mg/day. Over the subsequent 5 weeks, theeosinophil counts decreased and then remained within the normal range with clozapinedosages ≤300 mg/day over 1 year of continued treatment. Blood dyscrasias are a well known potential adverse effect of clozapine. Eosinophilia has beenreported and is believed to be a marker for potentially serious inflammatory conditions inclozapine-treated patients. No specific monitoring recommendations for eosinophilia exist, andproper management of clozapine-associated eosinophilia has been debated. Patients in whomangranulocytosis or other blood dyscrasias develop often rapidly re-experience the reaction onrechallenge. According to the present case report, as well as previously described patients, itappears that clozapine may be safely continued in patients with eosinophilia without signs orsymptoms of organ damage.
Roberts C, Mortenson L, Merrill D, Rafizadeh N, et al: Successful rechallenge with clozapine after eosinophilia.
American Journal of Psychiatry 2011;168 (November ):1147–1151. From Columbia University, New York, N.Y. One study
author disclosed financial relationships with several pharmaceutical sources.
Drug Trade Names: aripiprazole—Abilify; clozapine—Clozaril; haloperidol—Haldol; olanzapine—Zyprexa
Violence Prevention with Beta-Blockers
Beta-blockers have long been used in the management of acute aggression in a variety ofsettings. Limited evidence supports prophylactic use to prevent aggressive behavior. Two cases are presented here.
A 40-year-old male with bipolar schizoaffective disorder was hospitalized with delusions andviolent behavior. His delusions became less prominent with monthly injections of 100-mgfluphenazine decanoate plus oral clonazepam, quetiapine, and trihexyphenidyl, but heremained aggressive and impulsive. With a trial of pindolol, initiated at 5 mg b.i.d. and quicklyincreased to 10 mg b.i.d., the patient reported feeling significantly calmer. Within days he wasno longer experiencing aggressive or violent outbursts. Continued pindolol, administered onlyif the patient’s pulse was ≥60, was well tolerated, and he was discharged with no violentbehavior to a group home.
A 20-year-old male outpatient with antisocial personality disorder had been unsuccessfullytreated for a number of years with a wide variety of psychotropics, including antipsychotics,antidepressants, mood stabilizers, stimulants, and anxiolytics. The patient described himself ashaving difficulty controlling his emotions and "felt angry all the time." He consented to a trialof 40 mg propranolol b.i.d. Despite only taking half of the prescribed doses, the patient and hiscase worker reported improvement in his temper over the next several weeks and he wasnoticeably calmer and less agitated. He reported no adverse effects of propranolol treatment,and positive effects were maintained at 6-month follow-up. These case reports add to the evidence supporting prophylactic beta-blockers for violenceprevention. However, appropriate patients must be carefully selected because of potentiallyserious adverse effects. Beta-blockers are contraindicated in patients with asthma, bradycardia,atrioventricular block, uncompensated heart failure, and sick sinus syndrome, and must beused cautiously in patients with diabetes. Newman W, McDermott B: Beta blockers for violence prophylaxis: case reports [letter]. Journal of Clinical
Psychopharmacology 2011;31 (December):785–786. From the University of California Davis School of Medicine,
Sacramento, Calif. The authors declared no competing interests.
Drug Trade Names: clonazepam—Klonopin, and others; fluphenazine decanoate—Prolixin, and others;
pindolol—Visken, and others; propranolol—Inderal; quetiapine—Seroquel; trihexyphenidyl—Artane
Reference Guide
Odds Ratio: A comparison of the probability of an event in two groups. An odds ratio of 1
implies that the event is equally likely in both groups. An odds ratio greater than 1 indi-
cates that the event is more likely to occur in that group than in the comparison group.
Study Rating: A measure of how well a study conforms to quality standards. The study
rating uses a checklist system based on the comprehensive Strength of Evidence Report
from the Evidence-based Practice Center Program of the Agency for Healthcare Research
and Quality (AHRQ). The rating checklists have been posted at www.alertpubs.com.
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Consulting Editor: Steven J. Schleifer, MD, UMDNJ-New Jersey Medical School
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Founding Editor: Michael J. Powers
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