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2002
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Drug
That’s Been Used Illicitly Gets OK’d
For Muscle Disorder
The substance that’s been used illegally as the
“date rape” drug has received FDA approval
for treating cataplexy. This condition occurs in many
patients with narcolepsy and causes sudden muscle weakness
and loss of muscle control. The approved drug, called
Xyrem, is a form of sodium oxybate (also known as gamma
hydroxybutyrate, or GHB). GHB was once sold as a dietary
supplement but was ordered off the market after serious
adverse events, including death, were increasingly reported.
Because of its history, Xyrem is classed as a Schedule
III Controlled Substance, with strict criminal penalties
for illegal distribution. It will be available only through
one centralized pharmacy. Other precautions against abuse
include prescriber training, patient education with an
FDA-approved Medication Guide, and a patient and physician
registry. Side effects of the drug include confusion,
depression, nausea, vomiting, dizziness, headache, bedwetting,
and sleepwalking. Abuse of the drug may cause dependence
and severe withdrawal symptoms.
U.S.
Food and Drug Administration. “FDA approves Xyrem
for cataplexy attacks in patients with narcolepsy.”
2002. www.fda.gov/bbs/topics /answers/2002/ans01157.html
(19 July 2002).
Error
Watch: Did Your Patient Get Seroquel Or Serzone?
Confusion between the look-alike, sound-alike brand names
of two psychotherapeutic agents has led to medication
errors and adverse events. According to reports to the
manufacturers and the FDA, verbal and written prescriptions
for the schizophrenia treatment Seroquel (generic name:
quetiapine fumarate) and the antidepressant Serzone (nefazodone
HCl) were incorrectly interpreted, labeled, or filled.
The reported adverse events included mental status deterioration,
hallucination, paranoia, nausea, diarrhea, vomiting, muscle
weakness, lethargy, and dizziness, along with other complications.
In light of such errors, it’s important to teach
patients the distinguishing features of their meds: The
name “Seroquel” is imprinted on each tablet.
Serzone tablets carry the letters “BMS” (for
the manufacturer’s name).
AstraZeneca.
“Important alert regarding medication errors.”
2002. www.fda.gov/medwatch/SAFETY/2002/seroquel.htm (14
June 2002).
Study:
OCs Don’t Raise The Risk Of Breast Cancer
A large study led by researchers from the Centers for
Disease Control and Prevention found no evidence that
previous or current use of oral contraceptives (OCs) significantly
increases a woman’s risk of breast cancer. This
contrasts with an earlier analysis that found a slight
but significant increased risk of breast cancer among
women who had stopped using OCs up to 10 years earlier.
The new study focused on women 35 to 64 years of age—both
blacks and whites—from sites across the country.
More than 75% had used OCs. Researchers interviewed 4,575
women with invasive breast cancer and 4,682 controls.
Among subgroups of women, factors such as a longer period
of OC use or higher-doses of estrogen didn’t consistently
raise the risk of breast cancer. In addition, no increased
risk was seen among OC users with a family history of
breast cancer or those who started OCs at a young age.
Marchbanks,
P. A., McDonald, J. A., et al. (2002). Oral contraceptives
and the risk of breast cancer. N Engl J Med, 346(26),
2025.
New
Safety Data Are Added To Celecoxib Labeling
The FDA approved important labeling changes on the safety
of the COX-2 drug celecoxib (Celebrex), based on a study
in more than 8,000 arthritis patients. Celecoxib was administered
at a dose of 400 mg—twice its highest approved dose
for rheumatoid arthritis and four times that for osteoarthritis—and
compared with standard doses of ibuprofen or diclofenac
sodium (Voltaren), two older nonsteroidal anti-inflammatory
drugs (NSAIDs). Even at this high dosage, the gastrointestinal
and cardiovascular (CV) safety of celecoxib was similar
to that of the older agents. As a result, the revised
celecoxib labeling states that there was no increased
risk for serious CV thromboembolic events—such as
MI, stroke, and unstable angina—compared with the
older agents. However, the FDA ruled that the revised
labeling must keep the warning about GI risks that are
associated with all NSAIDs. (No claims of superior GI
safety could be made.) The FDA did note that the inclusion
of patients on aspirin cardiotherapy may have obscured
the study’s results because of aspirin’s own
GI toxicity. At nine months, the cumulative rate of complicated
ulcers was 0.32% in patients on celecoxib alone vs. 1.12%
in those on celecoxib and aspirin.
U.S.
Food and Drug Administration. 2002. www.fda.gov/bbs/topics/answers
/2002/ans01151.html (14 June 2002).; and Pharmacia Corp.
2002. “FDA approves new Celebrex prescribing information.”
www.pharmacia.com/newsroom/product.asp (13 June 2002).
CDC
Advises Smallpox Vaccine For Select Personnel
The country’s expert panel on vaccine policy—the
Advisory Committee on Immunization Practices (ACIP) at
the Centers for Disease Control and Prevention (CDC)—has
recommended that smallpox vaccine be given to select healthcare
and safety personnel who would have direct contact with
victims of a bioterrorism attack. No decision on implementation,
however, has yet been made. According to ACIP’s
recommendation, those who should be vaccinated include
members of state response teams that would investigate
initial smallpox cases and pre-designated providers in
facilities where victims would be treated and isolated.
By making the recommendation, the CDC in effect called
upon bioterrorism planners to specify such response teams
and treatment facilities. This is the first time in three
decades that there has been a program in place for smallpox
vaccination. (Vaccination had eradicated the naturally
occurring virus in the United States.) Immunization won’t
be offered to all healthcare workers or to the general
public at this time because the potential adverse effects
outweigh the risk of exposure.
Centers
for Disease Control and Prevention. National Immunization
Program. “Use of smallpox (vaccinia) vaccine, June
2002.” 2002. www.cdc.gov/nip/smallpox/supp _recs.htm
(24 June 2002).
Pain
Clinic
Can A Drug Abuser With AIDS Get This Type Of Pain Med?
Q Are opioids contraindicated for treating moderate to
severe pain in an AIDS patient with a history of IV drug
abuse? A No, they’re not. Prior IV drug abuse doesn’t
mean this patient couldn’t be treated with an opioid
for moderate to severe pain. It should, however, prompt
the clinician to think carefully about the route of administration
and the quantity of drug prescribed per visit. Establishing
a single prescriber is also recommended, to keep close
tabs on how much drug is being requested or taken. One
other precaution: Because patients with HIV/AIDS are often
on several medications, clinicians should be aware of
potential drug interactions. This patient’s complaint
of pain should be taken seriously and continually assessed
as it would be for any patient. HIV/AIDS patients may
suffer from several types of pain, such as peripheral
neuropathy, abdominal pain, muscle/joint pain, oropharyngeal
pain, radiculopathy, and painful dermatologic conditions.
Studies indicate that pain in ambulatory AIDS patients
often isn’t treated adequately. A multidisciplinary
approach is best and should address the patient’s
psychological/behavioral issues.
Sources:
1. Ellison, N. M., Finley, R., & Paice, J. (2002).
Management of pain in patients with HIV/AIDS. Dannemiller
Memorial Educational Foundation pain report, 1(4), 8.
2. Swica, Y., & Breitbart, W. (2002). Treating pain
in patients with AIDS and a history of substance abuse.
West J Med, 176(1), 33. THE AUTHOR MARY J. SCHOLZ, RN,
PhD, is a nurse clinician and behavioral medicine specialist
at Northwest Psychophysiology, an affiliate of Northwest
Neuroscience Institute in Seattle.
Infliximab
Shows It Can Put Crohn’s Disease Into Remission
Based on the results of a 54-week study, infliximab (Remicade)
has been approved for inducing and maintaining clinical
remission in patients with moderately active to severely
active Crohn’s disease who have had an inadequate
response to conventional therapy. The monoclonal antibody
already has indications for rheumatoid arthritis and reducing
the signs and symptoms of Crohn’s disease. In the
54-week trial, 57% of 545 patients responded to a single
infusion of infliximab within two weeks. Among the responders,
39% of those given maintenance therapy (5 mg/kg at weeks
2 and 6, then every eight weeks) achieved remission by
week 30 vs. 25% given placebo. At week 54, one-quarter
of patients on maintenance therapy were in remission and
had discontinued steroid use vs. 11% on placebo. Infliximab
shouldn’t be used in patients with heart failure
or active infection. As a result, clinicians need to screen
and monitor patients for the risk of heart failure, tuberculosis,
and infections.
Centocor.
“Remicade (infliximab). Crohn’s disease.”
2002. www.remicade-crohns.com (10 July 2002).
Beyond
Frown Lines: Botox Helps Stroke Patients
Botulinum toxin A—recently approved as Botox for
reducing frown lines—has been shown to reduce muscle
spasticity in the wrist and finger of stroke victims,
with resulting improvements in function. In a 12-week
trial, 126 subjects were given one set of IM injections
of the toxin (200 to 240 units) or placebo into their
wrists and fingers. Primary outcome measures included
pain reduction and the subjects’ ability to take
care of their personal hygiene, get dressed, and position
their hand. Each patient chose one area of function as
a principal target of treatment. At week six, 62% of those
given botulinum toxin A had significantly greater improvement
in function vs. 27% of those given placebo, and the improvement
continued to be seen through week 12. No significant difference
in adverse events was found.
Brashear,
A., Gordon, M. F., et al. (2002). Intramuscular injection
of botulinum toxin for the treatment of wrist and finger
spasticity after a stroke. N Engl J Med, 347(6), 395.
It’s
Official: Synthroid Is Here To Stay
The FDA has given formal approval for the marketing of
the Synthroid brand of levothyroxine sodium. The drug,
which is also sold under the brand names Levothroid and
Levoxyl, had been used for decades to treat hypothyroidism—long
before the current FDA drug-approval process was instituted.
But in 1997, the FDA asked all manufacturers to submit
data on their brands’ potency and stability or else
remove them from the market. All three are now approved.
Synthroid is indicated for primary, secondary, tertiary,
and subclinical hypothyroidism, and for suppression of
pituitary thyroid-stimulating hormone.
U.S.
Food and Drug Administration. “Abbott Laboratories’
Synthroid (levothyroxine sodium tablets, USP) confirmed
safe and effective through FDA approval.” 2002.
http://abbott.com/news/press_release.cfm?id=400 (5 Aug.
2002).
Help
For Women Who Have Constipation-Predominant IBS
The FDA has approved the first short-term treatment for
women with irritable bowel syndrome (IBS) whose primary
bowel symptom is constipation. The new product, tegaserod
maleate (Zelnorm), stimulates the peristaltic reflux by
activating serotonin-4 receptors in the GI tract, thus
reducing symptoms of pain and discomfort, bloating, and
constipation. The drug is not meant for women with diarrhea-predominant
IBS and isn’t approved for use in men. In three-month
trials, tegaserod improved symptoms in significantly more
patients compared with placebo, but the difference in
response rates declined between months one and three,
suggesting a decrease in efficacy over time. Diarrhea—in
most cases only a single episode—occurred more frequently
with tegaserod (9%) than with placebo (4%). Advise patients
taking the drug to report any new or sudden worsening
of abdominal pain immediately.
U.S.
Food and Drug Administration. “FDA approves first
treatment for women with constipation-predominant irritable
bowel syndrome.” 2002. www.fda.gov/bbs/topics/ANSWERS/2002/ANS01160.html
(5 Aug. 2002).
PROBLEM
RX
What’s The Best Treatment For Postpartum
Depression? Two months after giving birth,
a 32-year-old mother says she’s still extremely
tired and anxious despite having help with the baby. She’s
lost her appetite and continues to have prolonged periods
of sadness. Her symptoms are similar to those she experienced
after giving birth to her first child, six years ago.
Her doctor considers giving her an antidepressant he’s
prescribed often—amitriptyline (Elavil). Is this
the best choice? A No. Amitriptyline is from an older
class of drugs—the tricyclics. For initial therapy
for depression, experts recommend the selective serotonin
reuptake inhibitors (SSRIs)—which include sertraline
(Zoloft), paroxetine (Paxil), and fluoxetine (Prozac,
others)—because they’re easy to administer
and have a low risk of lethal overdose. To minimize side
effects in the postpartum period, it’s a good idea
for patients to take half the recommended dose for the
first four days, followed by small increases. It may take
a few weeks before symptoms improve, and treatment should
continue for six months after symptoms resolve. Psychotherapy
has also been shown to be effective. Postpartum depression
occurs in 13% of women after giving birth. Assessment
should rule out any thyroid problem and the so-called
“baby blues,” which may resemble depression
but typically resolves in about 10 days.
Source:
Wisne, K. L., Parry, B. L., & Piontek, C. M. (2002).
Postpartum depression. N Engl J Med, 347(3), 194. THE
AUTHOR LINDA M. PORTERFIELD, RN, PhD, is a clinical pharmacologist
and director of cardiovascular research at Arrhythmia
Consultants in Memphis. She works with her husband, James
Porterfield, MD, FACC, who is a cardiologist and electrophysiologist.
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