| Archives
2002
April
March
February
January
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FDA
Issues Consumer Advisory On Kava-Related Liver Injury
The FDA has issued a Consumer Advisory on the rare but
real risk of severe liver injury from dietary supplements
containing kava (Piper methysticum). Kava is used in supplements
promoted as aids for stress, sleeplessness, and menopausal
symptoms. These products have been associated with hepatitis,
cirrhosis, and liver failure—including cases requiring
liver transplantation. Consumers are advised to contact
their doctor before using kava-containing products if
they have liver disease or take medications that affect
the liver (such as cholesterol-lowering drugs). Those
who develop jaundice, brown urine, or other symptoms of
liver disease should contact their doctor immediately.
Providers should report any cases of liver and other injury
in patients using kava-containing supplements through
the FDA’s MedWatch program at (800) 332-1088, or
on the FDA’s Web site, www .fda.gov/medwatch.
Food and Drug Administration. “Kava-containing dietary
supplements may be associated with severe liver injury.”
2002. www.cfsan.fda.gov/~dms/addskava.html (26 Mar. 2002).
[TOP]
Study:
The Elderly Often Receive
Inappropriate Meds
Based
on a recent review of a 1996 population survey, the federal
Agency for Healthcare Research and Quality estimates that
21% of community-based elderly patients were prescribed
at least one of 33 drugs considered potentially inappropriate
because of their safety and efficacy profiles. The survey
included 2,455 individuals ages 65 or older. An expert
panel classified 33 drugs as either: (1) always to be
avoided in elderly patients, (2) rarely appropriate, or
(3) appropriate for some indications but often misused.
Researchers found that nearly 2.6% of patients used at
least one of 11 drugs that should always be avoided, including
barbiturates, flurazepam HCl, meprobamate, chlorpropamide,
meperidine HCl, pentazocine, trimethobenzamide HCl, dicyclomine
HCl, hyoscyamine sulfate, and propantheline bromide. They
also found that elderly women were twice as likely as
elderly men to be prescribed one of the 11.
Zhan, C., Sangl, J., et al. (2001). Potentially inappropriate
medication use in the community-dwelling elderly: Findings
from the 1996 Medical Expenditure Panel Survey. JAMA,
286(22), 2823.
[TOP]
Cancer
Drug Increases Anticoagulants’ Effects
A “Black Box” warning has been added to the
labeling for capecitabine (Xeloda), a recently approved
drug for colorectal and breast cancers because of serious
interactions with oral anticoagulants derived from coumarin,
including warfarin (Coumadin) and phenprocoumon. The interactions
led to altered coagulation parameters and/or bleeding
(including deaths) in patients given capecitabine while
on those anticoagulants. The effects occurred within days
and up to several months after capecitabine was started,
and in a few cases, within a month after it was stopped.
A pharmacological study of capecitabine and warfarin has
confirmed the interaction. The warning advises providers
to closely monitor patients’ anticoagulant responses
(INR or prothrombin time) “with great frequency”
and to adjust the anticoagulant dose as needed.
Based
on letter to healthcare professionals from Centocor Inc.,
October 18, 2001. “Important drug warning.”
www.fda.gov/medwatch/safety/2001/remicade_deardoc.pdf
(2 Nov. 2001).
[TOP]
COX-2s
Have An Edge Over Acetaminophen
In Arthritis A double-blind trial involving 382 osteoarthritis
(OA) patients found that COX-2 inhibitors provided greater
relief than acetaminophen for symptomatic knee OA. Guidelines
from the American College of Rheumatology recommend acetaminophen
as a first-line systemic therapy for symptomatic OA—in
part because of concern over GI side effects with NSAIDs.
This is the first study to compare COX-2s against maximum
doses of acetaminophen (4 gm/day). Patients, who were
40 and older, were assigned to receive either a once-daily
dose of rofecoxib (Vioxx) 12.5 mg, rofecoxib 25 mg, celecoxib
(Celebrex) 200 mg, or acetaminophen 1,000 mg four times
a day for six weeks. More patient withdrawals—mostly
due to lack of efficacy—occurred in the acetaminophen
group (31%) than among patients treated with the COX-2s
(18% – 19%). Across all measures, rofecoxib 25 mg
demonstrated greater efficacy than the other regimens
in relieving pain and minimizing morning stiffness, based
on assessments within the first six days and after six
weeks. At week six, the percentage of patients who had
a good or excellent response overall was 60% for rofecoxib
25 mg; 56% for rofecoxib 12.5 mg; 46% for celecoxib; and
39% for acetaminophen. The research was supported by Merck
& Co., Inc., manufacturer of rofecoxib.
Geba,
G., Weaver, A. L., et al. (2001). Efficacy of rofecoxib,
celecoxib, and acetaminophen in osteoarthritis of the
knee: A randomized trial. JAMA, 287(1),64.
[TOP]
Risk
Of Cardiac Events Grows When Statins Are Withdrawn
A retrospective study has found that stopping chronic
statin therapy in patients presenting with acute coronary
syndromes may impair vascular function and thus increase
their risk of a cardiac event. Researchers analyzed data
on 1,616 patients who had coronary artery disease and
sought treatment for chest pain. More than 1,100 of these
patients weren’t taking statins. Among the 465 who
were, statins were withdrawn in 86 (18.5%) of them during
or after admission. During a 30-day follow-up, the incidence
of death and nonfatal MI in patients taken off statin
therapy was nearly three times higher than in patients
who were kept on statins, and it tended to be higher (but
not significantly) compared with patients who never received
statins. Researchers believe that statins, in addition
to controlling lipid levels, have anti-inflammatory effects
that independently protect against a cardiac event. Based
on these results, the researchers recommend that statins
not be withdrawn in unstable cardiac patients.
Heeschen,
C., Hamm, C. W., et al. (2002). Withdrawal of statins
increases event rates in patients with acute coronary
syndromes. Circulation, 105(10), 1446.
[TOP]
FDA
Upgrades Steroid’s Rating For Pregnancy
The pregnancy rating for the inhaled corticosteroid budesonide
(Pulmicort Turbuhaler)—a maintenance therapy in asthma—has
been “upgraded” to Category B. In this case,
that designation means that although adverse effects on
the fetus were seen in animal studies, human studies haven’t
found a risk to the fetus in the first trimester, and
there’s no evidence of risk in later trimesters.
All other inhaled steroids are Pregnancy Category C. (Briefly
put, this classification means that animal studies either
have not been done or have shown a risk to the fetus,
and there are no adequate human studies during pregnancy.)
The change for budesonide is based on the FDA’s review
of data from three Swedish registries covering over 2,000
births. The rate of recorded congenital malformations
in infants born to mothers who used inhaled budesonide
during early pregnancy was similar to the rate seen in
the general population. The drug’s labeling, however,
cautions that the possibility of fetal harm can’t
be ruled out. The inhaler should be used during pregnancy
only if clearly needed, at the lowest effective dose,
and with monitoring.
Astra-Zeneca.
“FDA approves pregnancy rating label change for asthma
medication.” 2002. www.astrazeneca-us.com/news/article.asp?file=2002010301.htm
(23 Jan. 2002).
Pain
Clinic
When Your Pain Patient Has Trouble
Falling Asleep
A 68-year-old patient returns for follow-up of chronic
back pain after his hip surgery. He says his medication—oxycodone
HCl (OxyContin) 20 mg bid—controls his pain “fairly
well,” but he has difficulty falling asleep. Should
he be prescribed a sedative? Perhaps—but first you’ll
want to look into the matter a bit more. To help patients
sleep, a sedative-hypnotic called zolpidem tartrate (Ambien)
has been considered a good alternative to benzodiazepines,
such as lorazepam (Ativan), because the side effects of
those agents can increase the risk of falling and fracture.
Yet that risk appears to be a problem with zolpidem, too.
In a recent case-control study involving 1,222 elderly
hip fracture patients, the use of zolpidem was associated
with a nearly twofold increased risk of hip fracture compared
to controls. Given this risk, you’d be wise to inquire
about the exact nature of his sleep difficulty. Is he
more conscious of pain at bedtime? Does he consume caffeine
or take naps late in the day? Does he need to be more
physically active? Addressing the pain and recommending
behavioral changes may resolve the problem without the
need for a sedative.
Source:
Wang, P. S., Hohn, R. L., et al. (2001). Zolpidem use
and hip fractures in older people. J Am Geriatr Soc, 49(12),
1685. 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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