Original PDF Viewer

This embedded PDF preserves figures, tables, images, and layout.

Searchable Extracted Text

Page 1
By Shari J. Lynn, MSN, RN
Watch
A DRUG FOR OBESITY IS NOW
AVAILABLE OTC
-  Orlistat should not be used by
transplant recipients or people
who don't need to lose weight.
-  It can cause diarrhea, flatus with
discharge, and oily evacuation.
O
rlistat, a medication pre
scribed for obesity and sold
under the trade name Xenical,
now is available in an over-the
counter formulation marketed as
Alli (the prescription product
will continue to be available at
the higher dose). It's recom
mended for use in adults 18
years of age and older but isn't
intended for people who either
have difficulty absorbing food or
do not need to lose weight.
Patients who've undergone
organ transplantation shouldn't
take it because of a possible
interaction with immunosup
pressant medication (specifically,
cyclosporine). Use of the drug by
patients taking anticoagulants or
medication to treat diabetes or
thyroid disease may not be
appropriate, and an NP or a
physician should be consulted
before a patient starts taking it.
Orlistat is dispensed in 60-mg
capsules that can be taken as
often as three times a day with
each meal containing fat. For
maximum effect, the drug
should be used as part of a regi
men that includes a low-calorie,
low-fat diet and an exercise pro
gram. Because orlistat is a lipase
inhibitor that decreases the intes
tinal absorption of dietary fats, it
Shari J. Lynn is a clinical instructor at
the Johns Hopkins University School of
Nursing in Baltimore. Contact author:
slynn@son.jhmi.edu. Drug Watch is
coordinated by Diane S. Aschenbrenner,
MS, APRN,BC: dianea@son.jhmi.edu.
can have adverse gastrointestinal
effects, including diarrhea, flatus
with discharge, bowel urgency,
oily evacuation, fecal inconti
nence, and abdominal pain;
patients should be made aware
of this. Also, because of the pos
sibility that the drug will induce
the loss of certain nutrients,
patients taking orlistat should be
instructed to take a multivitamin
at bedtime.
U.S. Food and Drug Administration. FDA
news: FDA approves orlistat for over-the
counter use. 2007 Feb 7. http://www.fda.
gov/bbs/topics/NEWS/2007/NEW01557.
html; Roche. [Label information]: Xenical
(orlistat) capsules. 2007 Jan. http://www.
rocheusa.com/products/xenical/pi.pdf.
AN ASTHMA DRUG AND
ANAPHYLAXIS: A STRONGER
WARNING
-  Anaphylaxis tends to occur
within two hours but may occur
as long as 24 hours after admin
istration.
-  Anaphylaxis can occur even
after a patient has used the drug
many times.
T
he Food and Drug Admin
istration (FDA) has asked
the manufacturer of omalizumab
(Xolair) to add a black box warn
ing to the labeling. The drug,
which is taken for asthma caused
by allergies, has been associated
with anaphylaxis. The FDA has
also requested that a medication
guide be included with the pack
aging. Omalizumab was approved
in 2003 for the treatment of
adults and adolescents (12 years
of age or older) with moderate-to
severe persistent asthma attribut
able to allergy to pollen, grass,
or dust in whom inhaled steroids
don't work well.
At the time omalizumab was
approved, anaphylaxis had been
identified as a possible adverse
effect (on the basis of three cases
identified in 3,507 patients
involved in clinical trials, an
incidence of approximately
one in 1,000, although retro
spective analysis revealed two
additional cases). In the 48 post-
marketing cases of anaphylaxis
after the use of omalizumab
reported between June 2003 and
December 2005, two issues
raised significant concern: first,
while most (71%) occurred
within the first two hours of
administration, 13% occurred as
long as 24 hours afterward; sec
ond, in a majority of cases
(56%), anaphylaxis first occurred
after repeated administration,
sometimes after two years of
treatment with the drug.
Nurses should be prepared
for medication-related life-
threatening emergencies after the
administration of omalizumab.
The drug should be administered
in a clinician's office and the
patient carefully observed for at
least two hours for dizziness,
labored breathing, tightness of
the chest, syncope, hives and
itching, and swelling of the
mouth and throat, and emer
gency medication and equipment
should be close at hand.
Education provided to patients
should include guidance in the
recognition of the symptoms of
anaphylaxis, and they should be
given an epinephrine autoinjec
tor (the EpiPen, for example) in
case of a later reaction.
U.S. Food and Drug Administration. FDA
news: FDA proposes to strengthen label warn
ing for Xolair. 2007 Feb 21. http://www.fda.
gov/bbs/topics/NEWS/2007/NEW01567.
html; U.S. Food and Drug Administration.
Information for healthcare professionals:
Omalizumab (for subcutaneous use) (mar
keted as Xolair). 2007 Feb. http://www.
fda.gov/cder/drug/InfoSheets/HCP/
omalizumabHCP.pdf.
ajn@wolterskluwer.com
AJN t June 2007 t Vol. 107, No. 6
35

Page 2
Watch


FURTHER REVISIONS TO THE
LABELING OF TELITHROMYCIN
-  The FDA has rescinded two of
the three previously approved
indications for the antibiotic
telithromycin.
-  The drug packaging will include
a new black box warning con
cerning the exacerbation of
myasthenia gravis.
F
or the second time in a year,
the Food and Drug Admin
istration has announced revisions
to the labeling of the ketolide
antibiotic telithromycin (Ketek)
(see Drug Watch, October 2006).
Two of the three formerly
approved indications have been
rescinded: it's no longer approved
for the treatment of either acute
bacterial sinusitis or acute bacte
rial exacerbations of chronic
bronchitis. The annulment of the
indications was precipitated by
the recommendation that emerged
from a joint meeting of the
Anti-Infective Drugs Advisory
Committee and the Drug Safety
and Risk Management Advisory
Committee held on December 14
and 15, 2006. At that meeting it
was concluded that the balance
between the risks and benefits of
the drug no longer supports the
agency's approval of the two uses
because of case reports of rare
but sometimes fatal hepatoxicity
(including liver failure) and sub
sequent reports of drug-related
adverse events, including distur
bances of vision and loss of con
sciousness.
Telithromycin is still approved
for the treatment of mild-to
moderate community-acquired
pneumonia. However, because of
reports of both life-threatening
and fatal cases of respiratory
failure of rapid onset and pro
gression in patients with myas
thenia gravis who took the drug,
a new black box warning states
that it is contraindicated in that
population. The revised warning
36
AJN t June 2007 t Vol. 107, No. 6
section advises of the risks of
visual disturbances and loss of
consciousness, in addition to the
warning of hepatotoxicity that
was already strengthened in June
2006. A medication guide for
patients will also be developed.
Nurses should include informa
tion on the risks associated with
the use of telithromycin in the
education provided to patients
and instruct patients to read the
medication guide carefully.
U.S. Food and Drug Administration. FDA
news: FDA announces label and indication
changes for the antibiotic Ketek. 2007 Feb
12. http://www.fda.gov/bbs/topics/NEWS/
2007/NEW01561.html; Center for Drug
Evaluation and Research. U.S. Food and
Drug Administration. Revised label for
Ketek (telithromycin) tablets. Rockville, MD;
2007. http://www.fda.gov/cder/foi/label/
2007/021144s012lbl.pdf.
ADHD MEDICATION: RISKS AND
WARNINGS
-  ADHD medications may increase
the risks of serious cardiovascu
lar and psychiatric events.
-  The risks of cardiovascular events
are even higher in children with
heart disease.
D
rugs used in the treatment of
attention deficit-hyperactivity
disorder (ADHD) have been
associated with serious cardio
vascular events and psychiatric
symptoms. The Food and Drug
Administration has asked the
manufacturers of all ADHD
drugs to create medication
guides to inform consumers of
those risks and of precautions
they can take.
The decision was made after
cases of serious cardiovascular
events--stroke and heart attack
in adults with certain risk factors,
and sudden death in patients with
underlying serious heart problems
or defects--had been reported in
patients taking ADHD medica
tions at the recommended doses.
The risks of both are considered
to be further heightened in chil
dren with diagnosed (or undiag
nosed) structural cardiovascular
defects or cardiomyopathy.
In addition, there have been
case reports of psychiatric events,
including unwarranted suspicion,
auditory hallucinations, and
mania in patients with no psychi
atric history. The agency's decision
was also prompted by recommen
dations developed at the Drug
Safety and Risk Management
Advisory Committee meeting
held in February 2006 and the
Pediatric Advisory Committee
meeting held in March; at the
first, public testimony revealed
widespread concern among par
ents whose children had died
while taking a drug for ADHD
that they had not received the
full, appropriate information
indicating that it could cause
serious harm. The medication
guides serve as an attempt to
provide such information to con
sumers, but black box warnings
will not be added to the labeling
of the products at present.
Committee recommendations
also call for further research on
the risks posed by ADHD med
ications.
It's imperative that a thor
ough health history, including
cardiovascular risks and psychi
atric problems, be obtained
and recorded in the patient's
medical record before the initia
tion of treatment with any ADHD
drug. Nurses should assure par
ents that such adverse effects,
while serious, appear to be rare
and that the medications have
been used safely in the vast
majority of patients. Children
treated with ADHD drugs have
improved attention spans and per
form better at school; their abil
ity to interact with peers can
also be improved by manage
ment of ADHD symptoms.
U.S. Food and Drug Administration. FDA
news: FDA directs ADHD drug manufactur
ers to notify patients about cardiovascular
adverse events and psychiatric adverse events.
2007 Feb 21. http://www.fda.gov/bbs/topics/
NEWS/2007/NEW01568.html.
http://www.nursingcenter.com

Page 3
A PRODUCT IS APPROVED FOR USE IN
VON WILLEBRAND DISEASE
-  Antihemophilic factor-von
Willebrand factor complex
(human) is used in patients with
von Willebrand disease who are
undergoing surgery or other
invasive procedures.
-  It is approved for use only when
desmopressin is either contraindi
cated or ineffective.
T
he Food and Drug Admin
istration has approved anti
hemophilic factor-von Willebrand
factor complex (human)
(Alphanate) for use in patients
with von Willebrand disease
(types 1 and 2) who have to
undergo invasive procedures or
surgery. Von Willebrand disease,
the most common inherited bleed
ing disorder, is caused by a defi
ciency in the von Willebrand fac
tor (factor VIII in the clotting of
blood, known also as the antihe
mophilic factor), which in nor
mal clotting helps platelets
aggregate and adhere to the blood
vessel wall. Antihemophilic
factor-von Willebrand factor
complex (human) is purified
from pooled human plasma from
screened and tested U.S. donors
and contains the clotting pro
teins that are either deficient or
defective in patients with von
Willebrand disease. Use of the
drug has been shown to dimin
ish the risk of bleeding during
surgical procedures. It's already
approved for the prevention and
control of bleeding in surgical
patients deficient in factor VIII
secondary to hemophilia A or
who have acquired factor VIII
deficiency. It hasn't been approved
for use in patients with severe
von Willebrand disease (type 3)
who need major surgery.
The first-line choice for man
aging surgery in patients with
von Willebrand disease is desmo
pressin (DDAVP and others); the
use of antihemophilic factor-
von Willebrand factor complex
(human) is restricted to those in
whom desmopressin use is either
ineffective or contraindicated.
Nurses working in the operat
ing room should be aware of the
use of antihemophilic factor-
von Willebrand factor complex
(human) and its possible adverse
effects (itching, pharyngitis,
paresthesia, headache, swelling
of the face, and rash and chills).
U.S. Food and Drug Administration. FDA
news: FDA approves new product to treat
von Willebrand disease. 2007 Feb 2. http://
www.fda.gov/bbs/topics/NEWS/2007/
NEW01553.html. t