The medical letter on drugs and therapeutics march 17 2014

The Medical Letter

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On Drugs and Therapeutics
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IN THIS ISSUE (starts on next page)

Mumps Outbreak.............................................................................................p 21
Intranasal Naloxone for Treatment of Opioid Overdose............................. p 21
Drugs for Gout................................................................................................. p 22

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The Medical Letter

®

On Drugs and Therapeutics
Published by The Medical Letter, Inc. • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofit Publication
Volume 56 (Issue 1438)
March 17, 2014

ALSO IN THIS ISSUE

Drugs for Gout .............................................. p 22

Mumps Outbreak
An outbreak of mumps has occurred among students at
Fordham University in New York. All of those who developed mumps had been vaccinated against the disease.
RECENT OUTBREAKS — Mumps outbreaks in the US
have occurred predominantly in vaccinated older teenagers and young adults who are ≥10 years past their last
measles-mumps-rubella (MMR) vaccination. Primary
vaccine failure, close living conditions such as in college
dormitories, and waning immunity could be contributing
factors. The relatively low incidence in older people could
be due to a lower level of exposure or superior immunity
from natural infection. In an outbreak in New York in 20092010, most of the cases occurred in persons who had previously received 2 doses of MMR vaccine; post-exposure
prophylaxis with a third dose of the vaccine was followed
by a rapid decline in the incidence of disease.1,2
RECOMMENDATIONS — During a mumps outbreak, the
Advisory Committee on Immunization Practices (ACIP)
recommends vaccination for all persons who might be exposed and do not have a history of vaccination or other
evidence of immunity.3 For school-age children and older
students at risk of exposure, vaccination consists of 2 doses of MMR vaccine at least 28 days apart.
The CDC recommends considering a third dose of
MMR vaccine for control of an outbreak in a highly vaccinated population in a setting with intense exposure,
high attack rates, and evidence of ongoing transmission for >2 weeks.4

MMR vaccine is contraindicated during pregnancy, in
patients with severe immunodeficiency, and in persons
with a history of a severe allergic reaction to any component of the vaccine, including neomycin. □

www.medicalletter.org
Take CME Exams

1. IU Ogbuanu et al. Impact of a third dose of measles-mumps-rubella vaccine on a mumps outbreak. Pediatrics 2012; 130:e1567.
2. AP Fiebelkorn et al. Mumps postexposure prophylaxis with a third
dose of measles-mumps-rubella vaccine, Orange County, New
York, USA. Emerg Infect Dis 2013; 19:1411.
3. HQ McLean et al. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations
of the Advisory Committee on Immunization Practices (ACIP).
MMWR Recomm Rep 2013; 62(RR-04):1.
4. AP Fiebelkorn et al, in Manual for the surveillance of vaccine-preventable diseases. 5th edition, CDC, 2012, chapter 9. Available
at: www.cdc.gov/vaccines/pubs/surv-manual/chpt09-mumps.html.
Accessed March 10, 2014.

Intranasal Naloxone for Treatment of
Opioid Overdose
The recent increase in deaths from heroin overdose in
the US has led to renewed interest in the opioid antagonist
naloxone, particularly in making it available as an intranasal spray to paramedics and possibly to relatives and
close friends of heroin users. Intravenous (IV) administration is preferred, but peripheral venous access may
be difficult to obtain in IV drug abusers, and exposure
to their blood may be hazardous.
PHARMACOLOGY — Naloxone is a semisynthetic
derivative of thebaine that is structurally similar to oxymorphone. It acts as a competitive antagonist at opioid receptors in the brain. Unlike other opioid antagonists, it has no opioid agonist effects. In patients with
opioid overdose, naloxone begins to reverse sedation,
respiratory depression, and hypotension within 1-2

minutes after IV administration and 2-5 minutes after
intramuscular (IM) or subcutaneous (SC) administration. It has a half-life of 30-80 minutes in adults, much
shorter than that of most opioids; the protective effect
may wear off as soon as 45 minutes after IV administration of a low dose.1
ADVERSE EFFECTS — It is not clear whether naloxone has any direct toxicity (seizures, cardiac arrhythmias, and myocardial infarction have been reported),
but it can precipitate acute withdrawal symptoms in opioid-dependent patients. Acute opioid withdrawal is associated with anxiety, piloerection, yawning, sneezing,

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21


Table 1. Some Clinical Studies of Naloxone for
Prehospital Treatment of Opioid Overdose
Study

Description

Results

AM Kelly et al2
(n = 155)
Prospective,
randomized

Suspected opioid overdose
2 mg IM or IN (in 5 mL)
naloxone

Response time

IN: 8 vs IM: 6 min
RR >10 at 8 min
IN: 63% vs IM: 82%
GCS >11 at 8 min
IN: 57% vs IM: 72%

D Kerr et al3
(n = 172)
Prospective,
randomized

Suspected opioid overdose
2 mg IM or IN (in 1 mL)
naloxone

TM Robertson
et al4
(n = 96)
Retrospective,
EMS records

Suspected opioid overdose
IN or IV naloxone

Response time
IN: 8.0 vs IM: 7.9 min
RR >10 and/or
GCS >13 at 10 min
IN: 72.3% vs IM: 77.5%
Response time

IN: 12.9 vs IV: 8.1 min
Increase in RR of >6
or in GCS of >6
IN: 66% vs IV: 56%

MA Merlin et al5 Confirmed opioid overdose
(n = 96)
2 mg IN or 0.4-2 mg IV
Retrospective,
naloxone
EMS reports

Median increase in RR
IN: 4 vs IV: 6
Median increase in GCS
IN: 3 vs IV: 4

rhinorrhea, nausea, vomiting, diarrhea, and abdominal
or muscle cramps, which are uncomfortable but rarely
life-threatening.
DOSAGE FOR OPIOID OVERDOSE — Naloxone hydrochloride is available in the US as 0.4- and 1-mg/mL
solutions for IV, IM, or SC administration. No singleagent oral formulation and no intranasal formulation is
commercially available.
An initial dose of 0.4-2 mg IV is recommended for
adults. It can be repeated every 2-3 minutes up to a
total of 10 mg. If the patient still has not responded, the
diagnosis of opioid overdose should be questioned. If
the patient responds initially, but respiratory depression
recurs when the effect of naloxone has worn off, naloxone can be given again as needed.
Naloxone can be administered intranasally using a mucosal atomizer device. A syringe is attached to a spray

tip that fragments the medication into a fine mist. The
usual intranasal dose (off-label) is 2 mg (1 mg per nostril), which can be repeated in 3-5 minutes.
Table 2. Some Naloxone Formulations
Formulation

Hospira

0.4 mg/mL
1 mL vial
10 mL vial
1 mL syringe
1 mg/mL
2 mL syringe

Amphastar

Cost1
$22.00
137.10
15.40
17.00

1. Approximate acquisition cost (WAC). Source: Analy$ource® Monthly (Selected
from FDB MedKnowledge™) March 5, 2014. Reprinted with permission by
FDB, Inc. All rights reserved. ©2014. www.fdbhealth.com/policies/drug-pricingpolicy. Actual retail prices may be higher.

22

1. Opiate antagonists: naloxone hydrochloride, in AHFS Drug
Information, Bethesda, MD: American Society of Health-System

Pharmacists, 2014, page 2259.
2. AM Kelly et al. Randomised trial of intranasal versus intramuscular
naloxone in prehospital treatment for suspected opioid overdose.
Med J Aust 2005; 182:24.
3. D Kerr et al. Randomized controlled trial comparing the effectiveness
and safety of intranasal and intramuscular naloxone for the treatment of suspected heroin overdose. Addiction 2009; 104:2067.
4. TM Robertson et al. Intranasal naloxone is a viable alternative to
intravenous naloxone for prehospital narcotic overdose. Prehosp
Emerg Care 2009; 13:512.
5. MA Merlin et al. Intranasal naloxone delivery is an alternative to intravenous naloxone for opioid overdoses. Am J Emerg Med 2010;
28:296.

Drugs for Gout
Related Article(s) since publication

GCS = Glasgow Coma Scale score (graded 0-15); IM = Intramuscular;
IN = Intranasal; IV = Intravenous; RR = Respiratory rate

Manufacturer

CONCLUSION — Naloxone can be life-saving in patients with opioid overdose. It is usually injected intravenously, intramuscularly, or subcutaneously, but intranasal administration may be an alternative. □

The goals of gout treatment are threefold: treating
acute inflammation, preventing flares, and lowering serum urate levels.1,2
ACUTE GOUT — Nonsteroidal anti-inflammatory
drugs (NSAIDs) – In most patients without renal disease,
peptic ulcer disease, or other contraindications, acute
exacerbations of gout can be treated successfully with
an NSAID, which should be started as soon as possible
after the onset of symptoms and taken regularly (not as

needed) until resolution of the flare. There is no convincing
evidence that indomethacin (Indocin, and others), a traditional choice, is more effective than other NSAIDs such as
ibuprofen (Motrin, and others) or naproxen (Naprosyn, and
others). In one controlled trial, high doses of the selective
cyclooxygenase-2 (COX-2) inhibitor celecoxib (Celebrex;
800 mg once, then 400 mg 12 hours later on day 1, followed by 400 mg bid for 7 days) were as effective as indomethacin 50 mg three times daily.3
Colchicine – Colchicine can be used for patients with
contraindications to NSAIDs. It should be started in
the first 24 hours after the onset of acute symptoms. A
1.2-mg dose followed by 0.6 mg one hour later is as effective as higher doses, with less toxicity.4 Diarrhea can
occur. Colchicine is a myotoxin; neuromyopathy can occur, especially in elderly patients or in those with hepatic or renal dysfunction. It is a substrate of CYP3A4
and the efflux transporter P-glycoprotein (P-gp). Fatal
toxicity has been reported in patients taking colchicine
with a strong CYP3A4 inhibitor such as clarithromycin
(Biaxin, and others) or a strong P-gp inhibitor such as
cyclosporine (Neoral, and others).5 Myopathy and rhabdomyolysis have been reported in patients taking colchicine with a statin or fibrate.

The Medical Letter • Volume 56 • Issue 1438 • March 17, 2014


Table 1. Some Drugs for Gout
Drug

Usual Adult Dosage

1

Cost

Anti-Inflammatory Drugs

Naproxen – generic
Naprosyn (Roche)

Colchicine – Colcrys
(Takeda)

Urate-Lowering Drugs
Allopurinol – generic
Zyloprim (Prometheus)
Febuxostat – Uloric
(Takeda)
Probenecid – generic
Pegloticase – Krystexxa
(Savient)

Acute: 750 mg, then
250 mg q8h
Prophylaxis4: 250 mg bid
x 6 weeks
Acute: 1.2 mg, then 0.6 mg
1 hour later
Prophylaxis4: 0.6 mg once/d
or bid x 6 months
100-900 mg once/d5
40-80 mg once/d
500-1000 mg bid
8 mg IV every 2 weeks

$0.352
8.653

5.882
145.323
15.45
925.20

2.40
43.80
214.20
36.00
10,780.00

1. Approximate wholesale acquisition cost (WAC) for 1 day’s treatment of an
acute attack, 1 course of prophylaxis, or 30 days of urate lowering at the lowest
recommended dosage. Source: Analy$ource® Monthly (Selected from FDB
MedKnowledge™) March 5, 2014. Reprinted with permission by FDB, Inc. All
rights reserved. ©2014. www.fdbhealth.com/policies/drug-pricing-policy. Actual
retail prices may be higher.
2. Cost of generic naproxen.
3. Cost of Naprosyn.
4. Not an FDA-approved indication.
5. To avoid gout flares, starting dosage should be no more than 100 mg/d and the
dose should be increased by 100 mg/d at 2-4 week intervals. Doses >300 mg/d
should be divided. The starting dose should be lowered in patients with moderate to severe renal impairment, but still should be titrated up to a maintenance
dose that may be higher than 300 mg.

Corticosteroids – Short courses of systemic corticosteroids such as prednisone or methylprednisolone
given orally or parenterally are effective for treatment of
acute flares. Intra-articular injection of methylprednisolone or triamcinolone is also considered effective, but
randomized controlled trials are lacking.6
Interleukin-1 (IL-1) Inhibitors – Canakinumab (Ilaris),7

which is FDA-approved for treatment of systemic juvenile idiopathic arthritis and is extraordinarily expensive,
has also been reported to be effective in relieving gout
pain and inflammation.8 Anakinra (Kineret), which is approved for use in rheumatoid arthritis, has also reduced
the pain and inflammation of gout and is widely used
off-label.9 These drugs may be options for patients with
gout who cannot tolerate or have contraindications to
NSAIDs, colchicine, and corticosteroids.
PREVENTION OF FLARES — Prophylaxis with colchicine or an NSAID can prevent flares of acute gout
associated with initiation of urate-lowering therapy. In
older patients or in those with comorbidities such as
renal disease or peptic ulcer disease, colchicine is
preferred.
URATE-LOWERING AGENTS — The goal of therapy
with urate-lowering drugs is to reduce the serum urate
level to <6.0 mg/dL and preferably to <5.0 mg/dL, but
asymptomatic, incidental hyperuricemia should not be

treated with urate-lowering drugs. Initial treatment of hyperuricemia should be with a xanthine oxidase inhibitor.
Xanthine Oxidase Inhibitors – Allopurinol lowers
serum urate levels by inhibiting xanthine oxidase, the
enzyme that converts xanthine into uric acid. It is effective in preventing recurrences of acute gout arthritis and in reducing the size of tophi, and may prevent
urate nephrolithiasis. The dosage of allopurinol should
be started at 100 mg/day and gradually increased until
the target urate level (<6 mg/dL) is reached. Doses as
high as 900 mg daily may be required; 300 mg daily is
widely used, but often fails to normalize serum urate levels. The starting dose should be lowered in patients with
moderate to severe renal impairment, but still should be
titrated up to a maintenance dose that may be higher
than 300 mg.
Adverse effects can include a variety of cutaneous reactions (including Stevens-Johnson syndrome), liver enzyme abnormalities, leukopenia, and generalized vasculitis. Severe cutaneous reactions are associated with

the HLA-B*5801 allele, which is especially common in
some Asians (e.g., Han Chinese, Thai); such patients
should be screened for this allele before receiving the
drug.
Febuxostat is a newer xanthine oxidase inhibitor that
can be used as an alternative to allopurinol.10,11 Febuxostat is effective in preventing acute gout recurrences and in reducing the size of tophi. Its effectiveness in preventing urate nephrolithiasis remains to be
established. The dose of febuxostat does not need
to be reduced in patients with moderate renal insufficiency. (Data are insufficient to make recommendations for patients with severe renal insufficiency.)
Stevens-Johnson syndrome and hypersensitivity reactions have also been reported with febuxostat.
Uricosuric Agents – When a xanthine oxidase inhibitor fails to lower serum urate to target levels, addition of
probenecid or another uricosuric agent may be effective. Probenecid can also be used as the initial uratelowering drug in patients who cannot tolerate xanthine
oxidase inhibitors. Probenecid can lower serum urate
levels to <6.0 mg/dL, but patients must have adequate
renal function for an optimal response. Uricosuric
agents increase the risk of urate nephrolithiasis and are
contraindicated in patients with kidney stones. Patients
with high urinary uric acid excretion (>800 mg/24 h) are
at high risk for nephrolithiasis and should not be treated
with uricosuric agents. Probenecid may decrease the
renal clearance of methotrexate. Salicylates can antagonize the uricosuric effect of probenecid.

The Medical Letter • Volume 56 • Issue 1438 • March 17, 2014

23


The antihypertensive drug losartan and the triglyceridelowering drug fenofibrate, which both have uricosuric
effects, have also been used (off-label) to treat hyperuricemia.12
Pegloticase – Pegloticase is an intravenous pegylated
urate oxidase enzyme that converts uric acid to allantoin,

an inert water-soluble purine metabolite, which is cleared
by the kidney.13 The drug rapidly lowers serum urate levels
in patients with gout, but it is very expensive and development of anti-pegloticase antibodies can interfere with its
continued effectiveness. Infusion reactions occur frequently, and anaphylaxis has been reported. Pegloticase should
be reserved for use in highly symptomatic patients with severe tophaceous gout who have not responded to both a
xanthine oxidase inhibitor and a uricosuric agent.
CONCLUSION — Acute flares of gout can be treated with
an NSAID, colchicine, or a corticosteroid. Colchicine and
NSAIDs can be used prophylactically to prevent flares associated with urate-lowering therapy. Allopurinol, febuxostat, or probenecid can prevent gout attacks by lowering
serum urate levels. Pegloticase can be used in patients
with severe disease when other urate-lowering drugs fail
to achieve target serum urate levels. □
1. D Khanna et al. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia.
Arthritis Care Res (Hoboken) 2012; 64:1431.
2. D Khanna et al. 2012 American College of Rheumatology guidelines for management of gout. Part II: therapy and antiinflammatory
prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken)
2012; 64:1447.
3. HR Schumacher et al. Efficacy and tolerability of celecoxib in the
treatment of acute gouty arthritis: a randomized controlled trial. J
Rheumatol 2012; 39:1859.
4. RA Terkeltaub et al. High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter,
randomized, double-blind, placebo-controlled, parallel-group, dosecomparison colchicine study. Arthritis Rheum 2010; 62:1060.
5. Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med
Lett Drugs Ther 2013; 55:e44.
6. MD Wechalekar et al. Intra-articular glucocorticoids for acute gout.
Cochrane Database Syst Rev 2013; 4:CD009920.
7. Canakinumab (Ilaris) for systemic juvenile idiopathic arthritis. Med
Lett Drugs Ther 2013; 55:65.
8. N Schlesinger et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised,
multicentre, active-controlled, double-blind trials and their initial

extensions. Ann Rheum Dis 2012; 71:1839.
9. P Ghosh et al. Treatment of acute gouty arthritis in complex hospitalized patients with anakinra. Arthritis Care Res (Hoboken) 2013;
65:1381.
10. Febuxostat (Uloric) for chronic treatment of gout. Med Lett Drugs
Ther 2009; 51:37.
11. MA Becker et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS
trial. Arthritis Res Ther 2010; 12:R63.
12. S Takahashi et al. Effects of combination treatment using anti-hyperuricaemic agents with fenofibrate and/or losartan on uric acid
metabolism. Ann Rheum Dis 2003; 62:572.
13. Pegloticase (Krystexxa) for treatment of refractory gout. Med Lett
Drugs Ther 2011; 53:9.

24

Coming Soon in The Medical Letter:
Golimumab (Simponi) for Ulcerative Colitis
Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis
Anoro Ellipta: An Inhaled Umeclidinium/Vilanterol Combination for
COPD
Coming Soon in Treatment Guidelines:
Drugs for Peptic Ulcer Disease and GERD
Drugs for Hypertension

The Medical Letter

®

On Drugs and Therapeutics
EDITOR IN CHIEF: Mark Abramowicz, M.D.
EXECUTIVE EDITOR: Gianna Zuccotti, M.D., M.P.H., F.A.C.P., Harvard Medical School

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The Medical Letter • Volume 56 • Issue 1438 • March 17, 2014


The Medical Letter

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Online Continuing Medical Education
To take CME exams and earn credit, go to:
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Issue 1438 Questions
(Correspond to questions #31-36 in
Comprehensive Exam #70, available July 2014)
Mumps Outbreak
1.

Recent mumps outbreaks in the US have occurred predominantly in:
a. preschool children
b. school-age children
c. young teenagers
d. older teenagers and young adults

2.

For control of an outbreak in a highly vaccinated population, the CDC
recommends considering use of:
a. IVIG
b. one more dose of MMR vaccine
c. antiviral drugs
d. all of the above

Intranasal Naloxone for Treatment of Opioid Overdose
3.

Advantages of intranasal over IV administration of naloxone include:
a. more rapid onset of action
b. less renal toxicity
c. safer for the provider
d. all of the above

4.

If a patient with suspected opioid overdose has not responded to a total of
10 mg of naloxone IV:
a. a continuous drip infusion of naloxone should be started
b. a 5-mg bolus of naloxone should be injected
c. 50 mg of diphenhydramine should be injected
d. the diagnosis of opioid overdose should be questioned

Drugs for Gout
5.

A 44-year old African-American man with a history of gout and peptic ulcer
disease for which he is taking clarithromycin to eradicate Helicobacter
pylori infection presents with an acute flare of gout. The safest treatment for
the flare in this patient would probably be:
a. an NSAID
b. colchicine
c. a short course of prednisone
d. cyclosporine

6.

Patients with gout and high urinary uric acid excretion should not be treated
with:
a. allopurinol
b. febuxostat
c. probenecid
d. any of the above

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Physicians, nurse practitioners, pharmacists, and physician assistants may earn 1 credit with this exam.
MISSION:
The mission of The Medical Letter’s Continuing Medical Education Program is to support the professional development
of healthcare professionals including physicians, nurse practitioners, pharmacists, and physician assistants by providing
independent, unbiased drug information and prescribing recommendations that are free of industry influence. The program
content includes current information and unbiased reviews of FDA-approved and off-label uses of drugs, their mechanisms
of action, clinical trials, dosage and administration, adverse effects, and drug interactions. The Medical Letter delivers
educational content in the form of self-study material.
The expected outcome of the CME Program is to increase the participant’s ability to know, or apply knowledge into
practice after assimilating, information presented in materials contained in The Medical Letter.
The Medical Letter will strive to continually improve the CME program through periodic assessment of the program and
activities. The Medical Letter aims to be a leader in supporting the professional development of healthcare professionals
through Core Competencies by providing continuing medical education that is unbiased and free of industry influence.
The Medical Letter is supported solely by subscription fees and accepts no advertising, grants, or donations.
GOAL:
Through this program, The Medical Letter expects to provide the healthcare community with unbiased, reliable, and
timely educational content that they will use to make independent and informed therapeutic choices in their practice.
LEARNING OBJECTIVES:
Activity participants will read and assimilate unbiased reviews of FDA-approved and off-label uses of drugs and
other treatment modalities. Activity participants will be able to select and prescribe, or confirm the appropriateness
of the prescribed usage of, the drugs and other therapeutic modalities discussed in The Medical Letter with specific
attention to clinical trials, pathophysiology, dosage and administration, drug metabolism and interactions, and patient
management. Activity participants will make independent and informed therapeutic choices in their practice.
Upon completion of this program, the participant will be able to:

1.
Discuss the recommendations for control of the recent mumps outbreak in New York.
2.
Review the efficacy and safety of intranasal naloxone for treatment of opioid overdose.
3.
Discuss the available pharmacologic options for the treatment and prophylaxis of gout.
Privacy and Confidentiality: The Medical Letter guarantees our firm commitment to your privacy. We do not sell any
of your information. Secure server software (SSL) is used for commerce transactions through VeriSign, Inc. No credit
card information is stored.
IT Requirements: Windows 98/NT/2000/XP/Vista/7/8, Pentium+ processor, Mac OS X+ w/compatible processor;
Microsoft IE 6.0+, Mozilla Firefox 2.0+ or any other compatible Web browser. Dial-up/high-speed connection.
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