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New
Warnings On Prempro, Premphase, And Premarin
New warnings and safety data have been added to the labeling
for three popular brands of hormone replacement therapy
for postmenopausal women: Prempro, Premphase, and Premarin.
The
changes follow news in July that the Prempro arm of a
large trial was halted because of an increase in breast
cancer and cardiovascular and venous thromboembolic events
in patients taking the drug. The study, called the Women's
Health Initiative (WHI), was evaluating both Prempro and
Premarin for their use in preventing coronary heart disease
(CHD).
Prempro
combines conjugated estrogens and the progestin medroxyprogesterone
acetate in a single tablet; Premphase provides the same
agents in two separate tablets. Premarin contains only
the conjugated estrogens. (The Premarin arm of the WHI
study-involving postmenopausal women who've had a hysterectomy-is
ongoing.) Revised labeling now states that none of the
three products is approved for preventing CHD or other
cardiovascular disease and that they shouldn't be prescribed
for those purposes. It also includes new warnings of the
potential increased risks seen in the WHI trial.
If
any of these products is considered for treating menopausal
symptoms, providers are advised to prescribe the lowest
effective dose for the shortest duration required, and
to periodically reevaluate the need for treatment. If
they're prescribed only for preventing postmenopausal
osteoporosis, alternatives should be considered.
U.S.
Food and Drug Administration. MedWatch. "Prempro/Premphase
(conjugated estrogens/medroxyprogesterone acetate tablets).
Premarin (conjugated estrogens tablets USP)." 2002.
www.fda.gov/medwatch/safety/2002/safety02.htm#premar (8
Oct. 2002). U.S. Food and Drug Administration. "FDA
statement on the results of the Women's Health Initiative."
2002. www.fda.gov/cder/drug/safety/WHI_statement.htm (8
Oct. 2002).
New
Oral Agent Approved For Treating Chronic Hep B
The FDA has approved adefovir dipivoxil (Hepsera) tablets
for treating chronic hepatitis B infection in adults who
have active viral replication and either histologically
active disease or elevated serum alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) levels. The
drug slows disease progression by blocking the virus'
replication.
In
two placebo-controlled studies in 467 patients, 53% -
64% of patients given adefovir had significant improvement
in liver inflammation vs. 25% - 35% of patients on placebo.
The degree of liver fibrosis was also reduced. In addition,
the drug was proven effective in patients with hepatitis
B virus (HBV) that was resistant to the antiviral drug
lamivudine (Epivir, Epivir-HBV).
A
severe, acute exacerbation of infection occurred in 25%
of patients following cessation of adefovir-an adverse
effect seen with other chronic HBV agents. Liver function
should be monitored at repeated intervals after the drug
is stopped. Kidney toxicity was reported in patients who
had, or were at risk of, kidney dysfunction.
U.S.
Food and Drug Administration. "FDA approves new treatment
for chronic hepatitis B." 2002. www.fda.gov/bbs/topics/ANSWERS/2002/ANS01163.html
(25 Sept. 2002). Gilead Sciences. "FDA approves Gilead's
Hepsera for the treatment of chronic hepatitis B."
2002. www.hepsera.com/pressrelease1.asp (25 Sept. 2002).
Platinum-Based
Drug OK'd For Advanced Colorectal CA
The FDA has approved a new platinum-based chemotherapeutic
agent for patients with advanced colorectal cancer. The
new drug, oxaliplatin (Eloxatin), is given in combination
with 5-fluorouracil plus leucovorin calcium (5-FU/LV).
It is currently approved only for treating colorectal
cancer that has recurred or progressed within six months
of first-line therapy with irinotecan HCl (Camptosar)
plus bolus 5-FU/LV.
The
approval was based on a trial in 463 patients given either
a combination of oxaliplatin plus 5-FU/LV, oxaliplatin
alone, or 5-FU/LV alone. The percentage of patients with
at least a 30% decrease in tumor size for four weeks or
more was 9% for oxaliplatin plus 5-FU/LV, 1% for oxaliplatin
alone, and 0% for 5-FU/LV alone. The combination of oxaliplatin
and 5-FU/LV also delayed tumor progression longer than
the other two treatments. No data on survival are yet
available.
Oxaliplatin
has side effects typical of chemotherapy agents. It also
may cause anaphylactic-like reactions and peripheral sensory
neuropathies. It shouldn't be used during pregnancy.
U.S.
Food and Drug Administration. "FDA approves Eloxatin
for colorectal cancer." 2002. www.fda.gov/bbs/topics/news/2002/new00825.html
(13 Aug. 2002). Sanofi-Synthelab. "Eloxatin, chemotherapy
for advanced colorectal cancer, receives approval from
the U.S. Food and Drug Administration." 2002. http://en.sanofi-synthelabo.com/press/ppc_6168.asp?ComponentID=6168&SourcePageID=632
(14 Aug. 2002).
Adverse
Drug Reactions Are Costly On Many Levels
Many hospital admissions due to adverse drug reactions
(ADRs) could be prevented by better monitoring and physician/patient
education, according to a retrospective study. Researchers
examined 437 ADR cases that occurred over nearly one year
in a university hospital. In 154 cases, an ADR was likely
the cause for admission-and 62% of these cases were deemed
potentially preventable. Those preventable cases led to
average stays of six days, for a total of 595 hospital
days. In many cases, the preventable factors were inadequate
monitoring of lab parameters, especially with patients
on anticoagulant and antidiabetic agents, and/or failure
to dose a drug based on a patient's age-related renal
function or a potential drug-drug interaction. Patients
made their share of errors, too. For example, they took
insulin or other antidiabetic agent without eating. Researchers
say that education strategies must focus on drug classes
that are often linked to ADRs, especially in patients
who are elderly, are on multiple meds, or have renal dysfunction.
McDonnell,
P. J., & Jacobs, M. R. (2002). Hospital admissions
resulting from preventable adverse drug reactions. Ann
Pharmacother, 36(9), 1331.
PAIN
CLINIC
Coping Skills Can Keep Pain From Sidelining Patients Q
A 54-year-old former professional football player makes
a return visit for bilateral knee and shoulder pain due
to osteoarthritis. His medications provide fairly adequate
relief, but he can no longer play sports or even run without
pain. He's despondent over this loss of activity. What
can you suggest?
AAs
an adjunct to pain medication, you'll probably want to
consider cognitive-behavioral interventions that can help
your patient feel that he still has some control over
his life. This is important because a person's thoughts,
emotions, and behavior affect his experience of chronic
pain. Ineffective coping styles-catastrophizing, avoidance,
passivity, and denial-tend to lead to a loss of self-esteem
and a sense of helplessness.
To
help this former football player, you might suggest the
following cognitive techniques: distraction (such as listening
to music) to keep him from focusing solely on pain, mental
imagery (placing himself in a pleasant scene), and cognitive
restructuring-that is, changing a maladaptive thought
("I hurt all the time") to a more affirming
one ("I have more pain when I try to do too much,
so I'll do what I can and then rest"). Behavioral
coping skills-in this case, adjusting one's daily activity-can
also help this patient control his pain. For example,
he may find that he can be more active if he sets goals
for activity and rest periods and gradually increases
the amount of activity he can comfortably handle.
Source:
American Pain Society. (2002). Guideline for the management
of pain in osteoarthritis, rheumatoid arthritis and juvenile
chronic arthritis. Glenview, IL: Author.
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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