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2002
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Rare
But Serious Risks Seen In Tamoxifen Chemoprevention
Studies have shown that tamoxifen citrate (Nolvadex) may
reduce the risk of invasive breast cancer in healthy women
at high risk of the disease and in those with ductal carcinoma
in situ. But new evidence emerging from these studies
indicates that tamoxifen may cause other life-threatening
conditions-including a rare, aggressive uterine sarcoma,
stroke, and pulmonary embolism. As a result, a boxed warning
has been added to the tamoxifen labeling. The warning
notes that, in women who already have breast cancer, tamoxifen's
benefits outweigh these risks. But providers are advised
to discuss the risks carefully with patients considering
tamoxifen for prevention of breast cancer. For more details
and a patient guide, key in "tamoxifen" on this
MedWatch Web page: www.fda .gov/medwatch/safety.htm. U.S.
Food and Drug Administration. MedWatch. "2002. Safety
information summaries. Nolvadex (tamoxifen citrate)."
2002. www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nolvad
(2 Jul. 2002).
Company's
IV Hospital Products To Have Unit-Of-Use Bar Codes To
help reduce the risk of medication errors, Abbott Laboratories
plans by early next year to have unit-of-use bar codes
on all of its more than 1,000 hospital injectable drugs
and IV solutions. Bar coding has been shown in hospital-based
studies to significantly decrease drug errors. The technology
enables a nurse to automatically confirm the "five
rights" of drug administration with a handheld scanner
and laptop computer. First, a scan of the patient's wristband
calls up a screen with such information as the patient's
meds, contraindications, and drug allergies. Then, as
the nurse scans the bar code on the unit dose of drug,
an alert will pop up on-screen if the patient, drug, dose,
route, or time of administration is incorrect. Abbott
Laboratories. "Abbott Laboratories announces initiative
to help reduce the risk of medication errors in hospitals,
pledges to bar code its injectable pharmaceuticals and
IV solutions." 2002. http://abbott.com/news/press_release.cfm?id=399
(16 Sept. 2002).
Important
News For Norplant Users Wyeth Pharmaceuticals has made
two big announcements regarding its five-year contraceptive,
the Norplant System. The first is that Norplant users
who were told to use a backup means of contraception because
of questions over the levels of levonorgestrel released
by the six-implant system no longer need to do so. The
second announcement is that the company doesn't plan to
resume distribution of the implant because of problems
with component supplies. In 2000, Wyeth advised providers
that certain lots of the implants (distributed on or after
October 20, 1999, and with 2004 expiration dates) might
not release enough levonorgestrel. Now, testing has shown
that the effectiveness of these lots was similar to that
described in clinical trials and product labeling. While
no backup contraception is needed, the use of condoms
to protect against STDs is still advised. Also, in light
of the company's announcement that it won't resume distribution
of the contraceptive, Wyeth is encouraging women who use
Norplant to see their doctors to discuss their options.
Until the end of the year, Wyeth will pay for removal
of the system or for nonhormonal backup methods of contraception.
For more information, call Wyeth at (800) 364-9809. U.S.
Food and Drug Administration. "Update on advisory
for Norplant contraceptive kits." 2002. www.fda.gov/medwatch
/safety/2002/norplant.htm (6 Aug. 2002). Wyeth Pharmaceuticals.
"Important Norplant System (levonorgestrel implants)
update. Back-up contraception no longer required on specified
lots." 2002. www.fda.gov/medwatch/safety/2002/norplant.htm
(5 Aug. 2002).
Oral
Rinse Relieves Mucositis Caused By Cancer Treatments Cancer
patients who develop oral mucositis/stomatitis as a result
of chemotherapy or radiation therapy sometimes experience
pain that makes it difficult to eat and drink. If the
pain's severe, dose reduction or delay of therapy may
be necessary. A new medication-Gelclair Concentrated Oral
Gel-is now available to manage and relieve oral mucositis/stomatitis
by forming a protective barrier that adheres to the mucosal
surface of the mouth. The drug is also indicated for relief
of pain or irritation related to oral surgery, traumatic
mouth ulcers (e.g., from braces or dentures), and diffuse
aphthous ulcers. The gel is dissolved in a few tablespoons
of water and gargled. In a small, open-label study in
oral surgery patients, use of the gel reduced mean pain
scores by 92% in five to seven hours after the first treatment.
Cell Pathways Inc. "Gelclair Concentrated Oral Gel."
2002. www.cellpathways.com/2_gelclair/index.html (18 Jul.
2002).
Patients
Need To Read Supplement Labels With Care If you have patients
who use herbal and other dietary supplements, nudge them
to get into the habit of reading the entire Supplement
Facts label. Tell them to check the active and inactive
ingredients (they might be allergic to some), to note
the serving size, and to follow directions on how much
to take per day. An herb may be "natural," but
that doesn't mean more is better. Recommend that all patients
read the FDA's consumer advice on supplements, available
at www.cfsan.fda.gov. Patients may not understand that
supplements are considered "foods" and therefore
don't have to meet the FDA pre-marketing requirements
for demonstrating efficacy and safety that drugs do. (If
the supplement has a brand-new dietary ingredient, however,
the manufacturer must submit safety data.) Supplement
labels can carry a general claim about an ingredient,
such as "improves mental functioning." But if
the label does so, it must also carry a disclaimer stating
that the claim hasn't been evaluated by the FDA and that
the product doesn't diagnose, treat, cure, or prevent
disease. The FDA tracks-and has acted upon-complaints
about supplement safety. If a patient has a reaction,
he should call his primary care provider and notify the
FDA at (800) FDA-1088. U.S. Food and Drug Administration.
"Tips for the savvy supplement user: Making informed
decisions and evaluating information." 2002. www.cfsan.fda.gov/~dms/ds-savvy.html
(10 Sept. 2002).
OTC
TALK
Your Challenge Grows As More Rx Drugs "Go OTC"
In fact, as more such "switches" occur, knowing
which OTC drugs your patient takes will be more important
than ever. Omeprazole (Prilosec), a prescription drug
for conditions such as gastric ulcer and erosive esophagitis,
is just one drug that may soon make the switch. The manufacturer
has asked the FDA for permission to switch the drug to
an OTC product at full prescription strength. The approved
use of "Prilosec 1," as the OTC version is to
be called, would be limited to preventing frequent heartburn.
An FDA advisory panel is leaning toward recommending approval,
but it first wants the proposed OTC label revised and
tested for consumer comprehension. One concern is that
consumers may continually self-treat chronic symptoms
that need medical evaluation. The panel thus wants the
label to clearly limit unsupervised use of the drug to
two to three 14-day courses a year. Whether or not omeprazole
or other prescription drugs go OTC, the bottom line is
clear: Ask patients which OTC drugs they use, why they
take them, and how often their symptoms occur. Patients
may not realize that just because they can treat symptoms
with a drug sold in the supermarket doesn't mean those
symptoms aren't serious. Source: Annual use limitations
for Prilosec 1 should appear in labeling-NDAC/GDAC. (2002).
FDC Reports-The Tan Sheet, 10(26), 10. THE AUTHOR JAMES
M. WOOTEN, PharmD, 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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