| Archives
2002
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Estrogen/Progestin
Trial Halted Due To Breast Cancer Risk
Researchers stopped a large study evaluating the benefits
and risks of estrogen/progestin therapy for preventing
coronary heart disease (CHD) after an interim review found
a 26% increased risk of invasive breast cancer with treatment
vs. placebo. The drug under study (Prempro) combines conjugated
equine estrogen and medroxyprogesterone acetate. The trial
involved more than 16,000 postmenopausal women with an
intact uterus. It was halted in May—five years into
the 81/2-year study. Other health risks were seen in the
treatment group. Specifically, the risk of stroke grew
by 41%, the risk of CHD (mostly nonfatal MI) grew by 29%,
and the risk of pulmonary embolism more than doubled.
Researchers estimate that over one year, for every 10,000
women taking estrogen/ progestin, the therapy might cause
seven more cases of CHD events, eight more strokes, eight
more pulmonary embolisms, and eight more invasive breast
cancers than would be seen among women not taking the
drug. But because an estimated 6 million women are on
the therapy, the additional risk could be substantial
over time. The benefits of treatment include reductions
in cases of hip fracture and colon cancer. The researchers
conclude that estrogen/progestin should not be used for
preventing CHD in this population. The study does not
address the risks and benefits of short-term use for relieving
postmenopausal symptoms. Women taking the drug should
consult with their healthcare providers.
Writing
Group for the Women’s Health lnitiative Investigators.
(2002). Risks and benefits of estrogen plus progestin
in healthy postmenopausal women. JAMA, 288(3), 321. National
Institutes of Health, National Heart, Lung, and Blood
Institute. “NHLBI stops trial of estrogen plus progestin
due to increased breast cancer risk, lack of overall benefit.”
2002. www.nih.gov/news/pr/jul2002/nhlbi-09.htm (10 Jul.
2002).
[TOP]
A
New Once-Weekly Option For Treating Osteoporosis
Postmenopausal women on daily risedronate sodium (Actonel)
for the prevention and treatment of osteoporosis now have
a more convenient option—a 35 mg, once-weekly regimen.
The effectiveness of the new dosage was proven equivalent
to 5 mg once daily in a year-long study of nearly 1,500
postmenopausal women. Both regimens produced similar,
significant increases vs. baseline in bone mineral density
in the lumbar spine and hip. Adverse events were also
similar, most frequently infection, arthralgia, and constipation.
Risedronate shouldn’t be used in patients who have
hypocalcemia, who can’t stay upright for at least
30 minutes, or who have severe renal impairment. Other
bisphosphonates, such as alendronate sodium (Fosamax),
also have a once-weekly dosage. Because these drugs may
cause upper GI disorders, including ulcers, patients must
stand or sit upright for a least a half hour after taking
a tablet.
Aventis
Pharmaceuticals. “FDA approves Actonel for once-a-week
use.” 2002. www.aventis.com/main/0,1003,en-xx-10590-49456—,ff.html
(21 May 2002).
[TOP]
Irritable
Bowel Syndrome Drug Returns Under Strict Conditions
In response to requests from patients suffering from severe
irritable bowel syndrome (IBS), the FDA has allowed alosetron
HCl (Lotronex) to be put back on the market—but with
a risk management program to help assure its safe use.
Alosetron was withdrawn in November 2000 following reports
of serious and life-threatening cases of ischemic colitis
and complications from constipation. Many of the patients
required hospitalization and surgery; four died. The approved
use of alosetron is limited to the treatment of women
with severe diarrhea-predominant IBS who have failed to
respond to conventional therapy. To further minimize the
risk of complications, only qualified physicians who enroll
in a risk management program will be permitted to prescribe
the drug. They must sign an agreement stating that they
can diagnose and manage the complications, will fully
educate patients on the risks and benefits of alosetron,
and will report adverse events to the drug’s manufacturer.
Physicians will then be given an FDA-approved Medication
Guide to give to patients, plus stickers to place on the
alosetron prescriptions that they write. Pharmacists won’t
be allowed to fill prescriptions that don’t carry
the sticker and are to give patients the Medication Guide
with each refill.
For
further details, visit the FDA’s “Lotronex Information”
Web site at www.fda.gov/cder/drug/infopage/lotronex /lotronex.htm,
or call the manufacturer, GlaxoSmith-Kline, at (888) 825-5249.
U.S. Food and Drug Administration. “FDA approves
restricted marketing of Lotronex.” 2002. www.fda.gov/bbs/topics/news/2002/new00814.html
(12 Jun. 2002).
[TOP]
Abrupt
Baclofen Withdrawal Poses Rare But Serious Risk
A “Black Box” warning has been added to the
labeling for baclofen injection (Lioresal Intrathecal)
because of rare cases of life-threatening complications
and deaths when therapy was abruptly stopped. In the product’s
first nine years on the market, 27 cases of withdrawal
syndrome were reported, and six patients died. The drug
is used to manage severe spasticity of cerebral and spinal
origin. Reasons cited for therapy stopping suddenly included
catheter malfunction/disconnection, low volume of drug
in the pump reservoir, end of pump battery life—and,
possibly, human error. Along with ensuring that the intrathecal
pump is correctly programmed and functioning (including
its alarms), providers need to stress to patients and
caregivers the importance of making scheduled refill visits
and watching for symptoms of baclofen withdrawal. These
may include a return to the patient’s former level
of spasticity, pruritus, hypotension, and paresthesias.
Rapid diagnosis and emergency treatment in an ED or ICU
is necessary if withdrawal occurs.
U.S.
Food and Drug Administration. “2002 Safety Alert
- Lioresal (baclofen injection).” 2002. www.fda.gov/medwatch/SAFETY/2002/baclofen.htm
(24 May 2002).
[TOP]
Intranasal
Antibiotic Can Cut Risk Of Postop Staph Infections
Giving the topical antibiotic mupirocin (Bactroban Nasal)
before surgery can reduce the incidence of nosocomial
Staphylococcus aureus infections among patients carrying
the bacteria in their noses, according to a recent double-blind
study. Mupirocin or placebo was administered intranasally
twice daily to 3,864 patients for up to five days before
surgery. Overall, the rate of nosocomial S. aureus infections
at the surgical site was similar among both groups of
patients. But when researchers looked just at those identified
as nasal carriers of the bacteria, only 4% of the 444
carriers given mupirocin developed nosocomial S. aureus
infections vs. 7.7% of the 447 carriers given placebo.
In addition, nasal carriage of S. aureus was eliminated
in 83% of mupirocin patients vs. 27% given placebo. Adverse
effects with mupirocin—mostly rhinorrhea and itching—were
similar to those seen with placebo.
Trish,
M., Perl, M. D., et al. (2002). Intranasal mupirocin to
prevent postoperative Staphylococcus aureus infections.
N Engl J Med, 346(24), 1871.
[TOP]
Accutane
Drug Guide Flags Psych Risks
The FDA has issued a risk management guide to help clinicians
recognize psychiatric disorders in adolescents and young
adults using isotretinoin (Accutane). A previous guide
was issued on the risk of birth defects. The new guide
warns that the acne drug may cause depression or psychosis,
and that, rarely, symptoms may be so severe as to lead
to suicidal ideation and suicide attempts. Advice on how
to spot the signs of depression and recommendations for
referring patients to a specialist are included, since
stopping isotretinoin may not be enough to resolve depressive
symptoms. How the drug might cause these reactions isn’t
known. For a copy of the guide and other isotretinoin
risk information, visit www.fda.gov/cder/drug/infopage/accutane.
U.S.
Food and Drug Administration. “Recognizing psychiatric
disorders in adolescents and young adults: A guide for
prescribers of Accutane (isotretinoin).” www.fda.gov/cder/drug/infopage/accutane/accutane_psychdisorders.htm
New
Guideline On Arthritis Pain Outlines Rx, Non-Rx Therapies
The American Pain Society (APS) released a new clinical
guideline for the management of pain in osteoarthritis
(OA), rheumatoid arthritis (RA), and juvenile chronic
arthritis (JCA). Created by a multidisciplinary expert
panel, the guideline advises a comprehensive approach
that includes ongoing pain assessment, medication, proper
nutrition, exercise, and education/counseling for patients
and families to improve self-care and coping skills. Acetaminophen
is the drug of choice for mild to moderate arthritis pain.
For severe pain from OA or RA, the recommended first-line
agents are the selective COX-2 non-steroidal anti-inflammatory
drugs (NSAIDs), such as celecoxib (Celebrex), rofecoxib
(Vioxx), or the latest one, valdecoxib (Bextra), just
approved in May. Non-selective NSAIDs (ibuprofen, naproxen,
others) should be considered if the patient does not respond
to the above therapies and isn’t at risk for NSAID-induced
GI side effects. If those alternatives don’t relieve
arthritis pain, the guideline recommends opioids, such
as oxycodone and morphine. Referral for surgery is advised
for most patients when medication fails and their movement
is severely impaired. The recommended analgesia for children
is the same as for adults.
American
Pain Society. “American pain society releases new
clinical guideline for treatment of arthritis pain.”
2002. www.ampainsoc.org/pub/principles.htm (30 May 2002).
OTC
Talk
New OTC Labeling: A Sight For Sore Eyes Reading the label
of an over-the-counter (OTC) remedy should start to get
a little simpler for your patients. That’s because
all OTC drugs that were made after May 15 must now bear
the easier-to-read label format required by the FDA. Instead
of over-crowded words in tiny type sizes, consumers will
find a standardized label format on all products that
has more “breathing room” and simpler language.
In addition, more space is devoted to directions for use.
The new labels are a step toward helping consumers use
OTC drugs more safely. For details about the new label
and self-care tips for patients, visit the Web site of
the National Council on Patient Information and Education
(www.be medwise.org).
National
Council on Patient Information and Education. “The
new drug facts label.” 2002. www.bemedwise.org/label/label.htm
(19 Jun. 2002). THE AUTHOR JAMES M. WOOTEN, a member of
the RN editorial board, is an assistant professor of medicine
at the University of Missouri School of Medicine, in Kansas
City, Mo.
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