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A New Way To Fend
Off The Flu (And It Doesn't Involve A Shot)
Many adults and children will have an effective alternative to the flu shot,
starting this fall. FluMist-the first intranasal flu vaccine in the United
States-has been approved for use in children ages 5 or older and in adults
under age 50. The vaccine is sprayed via a syringe into each nostril.
In studies, protective efficacy
was shown in 85% of adults and 87% of children. FluMist is also the first
live-virus vaccine approved in this country. The strains used are genetically
modified so that they can't grow well at body temperature, but can replicate
sufficiently to induce immunity.
FluMist shouldn't be used in
certain patients, such as those with asthma or those who are immunocompromised.
In trials, the most common adverse events were nasal congestion, runny nose,
sore throat, and cough.
U.S. Food and Drug
Administration. "First nasal mist flu vaccine approved." 2003.
www.fda.gov/bbs/topics/news/2003/new00913.html (19 June 2003).
Treatments Approved For Two
Genetic Disorders
The FDA has approved the first treatments for two rare inheritable metabolic
disorders-Fabry disease and mucopolysaccharidosis-I (MPS-I), a disorder that
includes Hurler syndrome.
Fabry disease causes a deficiency
of the enzyme alpha-galactosidase A. This deficit results in progressive
accumulation of lipids in blood vessels and within cells of the heart, kidneys,
and other organs. The new drug, agalsidase beta (Fabrazyme), is a form of the
natural enzyme and breaks down these fat deposits in the capillary endothelium
of the kidney and other cells.
Laronidase (Aldurazyme) is an
enzyme-replacement therapy for several forms of MPS-I. The disease results from
a deficiency in, or malfunction of, an enzyme called alpha-L-iduronidase, which
is needed to break down glycosaminoglycans in cells. Laronidase is approved to
treat the Hurler, Hurler-Scheie, and Scheie forms of MPS-I. Hurler syndrome,
the most severe form, causes physical deformities and impairs organ function,
often leading to early death in affected children.
Both drugs can cause serious
infusion reactions. Ongoing trials are evaluating their long-term effects and
safety.
U.S. Food and Drug Administration. "FDA approves first
treatment for Fabry disease." 2003.
www.fda.gov/bbs/topics/NEWS/2003/NEW00897.html (16 May 2003).
U.S. Food and Drug
Administration. "FDA approves first treatment for genetic metabolic
disorder including Hurler disorder." 2003. (16 May 2003).
FDA: Do Not Use Paxil To
Treat Pediatric Depression
The FDA is recommending that paroxetine HCl (Paxil) not be used to treat
depression in children and teens under age 18 until the agency has had a chance
to examine new safety data. The announcement was prompted by concerns over a
possible increased risk of suicidal thoughts and suicide attempts in youngsters
on the drug.
The FDA warns, however, that the
drug should not be stopped abruptly or without the supervision of a healthcare
provider. The announcement does not affect the use of paroxetine in adults.
U.S. Food and Drug
Administration. "FDA statement regarding the antidepressant Paxil for
pediatric population." 2003.
www.fda.gov/bbs/topics/answers/2003/ans01230.html (20 June 2003).
More News On The
Risks Of Estrogen/Progestin For HRT
New data and analysis continue to emerge on the risks associated with combined
estrogen/progestin hormone replacement therapy (CHRT). The latest developments
are:
* The FDA-mandated changes to the
labeling of postmenopausal estrogen and estrogen/progestin products are under
way. The changes warn about the increased risks for breast cancer and
cardiovascular and venous thromboembolic events, as established in the Women's
Health Initiative (WHI) study. They apply immediately to Prempro, Premphase,
and Premarin, but the FDA wants similar updates for other brands.
* Two new analyses shed more
light on the increased breast cancer risk associated with CHRT. One study using
WHI data found a significantly increased incidence of breast cancer among women
on CHRT (compared to placebo) within five years of use. In addition, the study
revealed that invasive tumors were more likely to be larger and at a more
advanced stage at diagnosis among CHRT users.
The second study found an
increased risk for breast cancer-invasive lobular tumors, in particular-among
women taking estrogen and progestin, regardless of whether they took the
progestin for less than or more than 25 days a month.
* Finally, a study evaluating the
effect of CHRT on memory in elderly women found that CHRT increased the risk of
dementia and did not protect against the risk of mild cognitive impairment.
U.S. Food and Drug
Administration. "Drug information: Estrogen and estrogen with progestin
therapies for postmenopausal women." 2002.
www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm (10 June 2003).
Shumaker, S. A., Legault, C., et
al. (2003). Estrogen plus progestin and the incidence of dementia and mild
cognitive impairment in postmenopausal women. The Women's Health Initiative
Memory Study: A randomized controlled trial. JAMA, 289(20), 2651.
Gann, P. H., & Morrow, M.
(2003). Combined hormone therapy and breast cancer: A single-edged sword. JAMA,
289(24), 3304.
New Protease
Inhibitor Allows Once-Daily Dosing
A new protease inhibitor is now available with a dosage that lightens the
"pill burden" on HIV patients-only two pills once daily. The new
drug, atazanavir sulfate (Reyataz), also avoids the increases in cholesterol
and triglyceride levels that are a common concern with protease inhibitors.
Others in this class have dosages of up to 24 pills a day-and all of them
(including atazanavir) must be taken with other antiretroviral agents.
In clinical trials, atazanavir
decreased the viral load and increased CD4 cell counts both in patients who had
been on other antiretroviral therapy and those who hadn't. Hyperbilirubinemia
was the most common lab abnormality, and it caused jaundice or scleral icterus
in 15% - 24% of study subjects. Nausea, infection, and GI disturbances are
among other adverse events. Atazanavir interacts with a number of commonly used
drugs, so specifically ask patients about all prescription, OTC, and herbal
products they're taking.
U.S. Food and Drug
Administration. "FDA approves a once daily protease inhibitor for HIV
infection." 2003. www.fda.gov/bbs/topics/answers/2003/ans01233.html (20
June 2003).
Bristol-Myer Squibb. "First
once-daily protease inhibitor - Reyataz (atazanavir sulfate) - approved by U.S.
Food and Drug Administration as part of combination therapy for the treatment
of HIV/AIDS." 2003. www.bms.com/news/press/data/pf_press_release_3803.html
(20 June 2003).
Error Watch
Computer Order Entry
Doesn't Reduce The Need For Vigilance
Computer drug order systems can help improve medication safety, but they're not
error-proof. Over a recent 51-month period, computer order entry turned up as a
cause in about 10% of drug errors that were reported to the USP's Medmarx
database.
In one case, the antiemetic
promethazine HCl (Phenergan) was listed as a possible choice on a patient's
initial standing orders. Although this drug was not "checked off"-and
therefore not ordered-it was mistakenly entered into the pharmacy computer
system along with other standing orders for the patient, who'd had a total knee
replacement. A medication administration record (MAR) was generated from the
computer and an RN gave the patient the drug without cross-checking the MAR
against the original order. The patient-who was on patient-controlled
analgesia-became so sedated he didn't respond to a sternal rub. He improved
after being given naloxone HCl (Narcan).
To minimize the risk of such
errors, the staff needs to be trained thoroughly in the use of computer drug
order systems and alerted to typical entry errors. Standardized order forms
should be designed so that it's clear which drugs have actually been selected.
For new/initial orders and orders for high-risk drugs (e.g., heparin),
cross-check computerized MARs with the original paper order.
THE AUTHOR
JOHN P. SANTELL, MS, RPh, is director, educational program initiatives, and
DIANE D. COUSINS, RPh,
is vice president at the U. S. Pharmacopeia Center
for the Advancement of Patient Safety (CAPS).
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