Transcript Ethical and Clinical Issues in Psychopharmacologic Therapy

Ephedrine Withdrawal Causes
Severe Psychiatric Symptoms:
A Case Report
Gene Makela, Pharm.D., BCPP
Kelly Slear
Marcella Hoyland
Kelly Slear
Marcella Hoyland
Pharmaceutical Investigations course,
West Virginia University
School of Pharmacy
The Case
64-year-old woman
long history of depression
abruptly increased symptoms of depression
and suicidal ideation with a plan to shoot
herself with a gun
difficulty sleeping
very low energy
decreased appetite, energy, and concentration
language and memory intact
The Case
judgment and insight poor
some signs of paranoia: during the interview she
reported “my family wants to get rid of me”
auditory hallucinations had returned recently: she
heard voices of her great aunt and uncle telling her
she was worthless, no good, and she should have
died when she was born
major depressive disorder with psychotic features
was diagnosed
Beck Depression Inventory (BDI) 63
Medications on Admission
mirtazepine 30mg daily
olanzapine 20mg daily
levothyroxine 0.88mg daily
conjugated estrogen 0.625mg daily
calcium carbonate 600mg twice daily
compliant with therapy, had been stable
Pharmacist Intervention
pharmacist faculty member with student
conducted detailed medication history with
following findings:
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patient was taking eight Xenadrine capsules
daily as a weight loss product for the past three
to four months
she reported that she took this product until two
days before admission to the hospital
at that time, on the advice of her daughter, she
abruptly discontinued the Xenadrine
Components of
®
Xenedrine
• Pantothenic acid 20mg
• Bitter orange - standardized to 2.5mg synephrine
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(similar to phenylephrine)
Ma Huang (ephedra) - standardized to 10mg
ephedrine
Guarana extract (100mg caffeine)
Ginger root 25mg
White willow bark (15mg salicin)
L-tyrosine, L-carnitine, Magnesium phosphate,
Deanol (choline precursor).
Note: normal dose is 2 capsules daily **
Bitter Orange
 Citrus aurantium
 Adrenergic amines
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Synephrine and octopamine (structurally
similar to epinephrine)
Hordenine
Tyramine
Methyltyramine
Background
 Common adverse effects of ephedrine reported to FDA by
consumers included elevated blood pressure, tachycardia, muscle
injury, psychosis, and memory loss
 FDA mandates rule in 1997 requiring manufactures of
supplements containing ephedrine that products be labeled with
information about risks and dangers
 FDA requires stronger labeling cautions in 2003: “ephedrine has
a significant risk of illness or injury to the consumer”
 FDA creates new Adverse Event Reporting System (CAERS) in
2003 to enable both health care providers and consumers to more
easily report adverse events from dietary supplements
 In February, 2004, the FDA acts to ban ephedra-containing
products
Resolution
mirtazepine dosage increased to 45mg at bedtime
over the next several days depression symptoms
and psychosis cleared without further intervention
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BDI 54 after 2 days
on the day of discharge, seven days after
admission, the patient reported feeling much better
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no suicidal thoughts or auditory hallucinations
hopeful about the future
discharge diagnoses included major depressive
disorder, recurrent, improving, Xenadrine abuse,
and Xenadrine withdrawal, resolving
Whatever happened to
Ephedrine Products?
 2008 internet search…
 Ephedra products still available
 many new products marketed using
bitter orange as a substitute for
MaHuang
Advertisement for ephBURN25
 “this product is made from the old ephedra
like the old lipodrene – smell the pills you’ll
agree”
 one capsule:
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MaHuang extract 8% Dark (25mg)
Caffeine 200mg
Other ingredients
Dose: 1 capsule twice daily
http://www .worldclassnutrition.com/eph1.html
Is Ephedrine Legal?
May be you ask yourself how we are still selling ephedrine after the ephedra ban on August 21,
2006. The answer is very simple.
Ephedrine HCL is not Ephedra. Ephedra f or weight loss has been banned. Ephedrine HCL is the
drug with ephedrine and it is used as a bronchodilator.
Although ephedra diet pills are banned, it is legal to sell remaining stocks of ephedra diet
pills.
We bought remaining inventory from our d istributors. Ephedra Products are highly effectiv e
weight loss supplements and hav e helped millions slim down to achieve their goals with proper
nutrition plan and using recommended dosage. We have a select amount and they will be gone
shortly as they are heav ily demanded.
http://www .buyvasoproephedrine.com/is-ephedrine-legal.html
Xenadrine RFA-1 is a registered trademark of Cytodyne Technologies S uperdrine RX-10 is a
registered trademark of American Generic Labs, LLC
http://www.wo rldclassnutrition.com/superdrine.html
Considerations
abrupt discontinuation of a stimulant taken for a long
period of time may lead to depressive symptomatology
In this unique case, however, a depressed patient stable
on medications was thrown into severe depression with
psychosis and suicidality as a result of the abrupt
withdrawal of a non-prescription dietary supplement
used for weight loss
despite combined antidepressant (mirtazepine) and
antipsychotic (olanzapine) treatment, discontinuation of
a non-prescription weight loss product was sufficient to
acutely de-stabilize this patient’s condition
Results / Conclusions
 abrupt discontinuation of non-prescription
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stimulant medication may cause severe
depressive symptomatology, even in a
patient whose depression had been
adequately controlled with prescription
medication
detailed medication history important in
clarifying cause of hospitalization, helpful
in defining the appropriate course of
treatment.
What Would Have Happened if:
There was no pharmacist intervention?…
possible:
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delayed or incorrect diagnosis
higher doses of prescribed medication…
potential adverse effects
addition of other medication to stabilize patient
…potential drug interactions
prolonged hospitalization
To Take Home
Psychiatric pharmacists can facilitate
accurate diagnoses by conducting
medication histories…
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Resultant pharmacotherapeutic approaches may
minimize length of stay for patients**
Current availability of ephedrine…need for
awareness
Questions ???