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2002
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A
New Triptan Is Available To Fight Off Migraine Attacks
A new oral “triptan” is now available for
the treatment of migraine attacks with or without aura.
Frovatriptan succinate (Frova) is the fifth agent in the
triptan class of drugs, which interrupts the neurological
mechanisms that cause migraines. Frovatriptan differs
from the other triptans by the duration of its half-life—26
hours (compared with six hours or less with other triptans)—though
no clinical advantage has been demonstrated based on this
difference. Studied against placebo in more than 4,000
patients, frovatriptan significantly relieved headache
pain and associated migraine symptoms like nausea and
sensitivity to light and sound. Only 1% of patients withdrew
because of adverse events. Because there’s a rare
risk of serious cardiac events with any of the triptans,
they should not be given to patients with a history of
ischemic or vasospastic coronary artery disease (CAD).
Patients at risk for CAD should be evaluated before being
given a triptan.
Based
on a news release from UCB Pharma, June 19, 2002: New
option now available to treat migraine sufferers.
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.
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