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A New
Hemophilia Drug Takes Some Risk Out Of Treatment
The FDA has approved the first recombinant DNA-derived clotting
factor to be produced without human or animal blood additives, which
carry a potential risk of infection. The drug, which will be marketed
under the brand name ADVATE, is appropriate for adults and children
of all ages who have hemophilia A. However, if patients have known
allergic-like reactions to mouse or hamster proteins, advise them
to speak to their doctor before taking the drug. Pregnancy may also
be a contraindication, since it's not known what effect ADVATE would
have on an unborn child. Nor is it known whether the product can
affect the ability to bear children.
Food and Drug Administration. "New recombinant antihemophilic
factor licensed."
2003. ww.fda.gov/bbs/topics/ANSWERS/2003/anso1241.html
(3 Aug. 2003). Baxter Healthcare. "FDA approves Baxter's ADVATE
for the treatment of hemophilia A." 2003. www.baxter.com/utilities/news/releases/2003/07-25-fda_advate.html.
(3 Aug. 2003).
New
Agent For Asthma Breaks The Chain Of Inflammation
A new type of drug for treating allergy-related asthma keeps immunoglobulin
E from binding with receptors on the surface of mast cells and basophils
and thus interrupts the allergic response that triggers inflammation.
Omalizumab (Xolair) is approved as a second-line treatment for patients
12 or older in whom inhaled steroids fail to control symptoms. Allergy-related
asthma should first be established by skin or blood test before
treatment. The drug is administered SQ every two or four weeks.
In two six-month trials in teens and adults with persistent symptoms
despite inhaled steroids, 80% - 85% of patients treated with omalizumab
had no exacerbations of their asthma symptoms vs. 70% - 75% of patients
on placebo. Long-term studies, however, are planned to evaluate
a possible association with cancer. More patients on omalizumab
developed a new or recurrent cancer (0.5%) vs. those on placebo
(0.2%). Anaphylaxis occurred in three patients given the drug.
U.S. Food and Drug Administration. "First biological drug for
allergy-related asthma approved." 2003. www.fda.gov/bbs/topics/answers/2003/ans0123.html
(24 June 2003). Genentech. "FDA approves Xolair, biotechnology
breakthrough for asthma." 2003. www.genentech.com/gene/news/press-releases/detail.jsp?detail=6287
(20 June 2003).
Arthritis
Drug Gets A New Indication
The FDA has approved etanercept (Enbrel), a genetically engineered
protein, for the treatment of active ankylosing spondylitis (AS),
a chronic inflammatory disease that primarily affects the lower
back and joints. Etanercept is already used in patients with rheumatoid
arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis.
Etanercept binds to tumor necrosis factor (TNF), a naturally occurring
protein in the body, and inhibits its action. TNF, which promotes
inflammation in the body, is found at elevated levels in the blood
and certain tissues of patients with AS. The recommended dose of
etanercept for adults with AS is 25 mg twice weekly. A study of
277 patients showed that 58% treated with etanercept twice a week
for six months showed significant improvement on measures of pain,
function, and inflammation, compared with 23% in a placebo group.
It's important to note, though, that the study excluded patients
with the most severe form of the disease. Because upper respiratory
infection was a main adverse effect, the drug should be avoided
in patients with active chronic or local infections. Use caution
with this drug in patients who are prone to infection, such as diabetics.
Etanercept should be discontinued if the patient develops an infection.
Food and Drug Administration.
"FDA approves Enbrel to treat ankylosing spondylitis."
2003. www.fda.gov/bbs/topics/ANSWERS/2003/ans01240.html (31 July
2003). Amgen Inc. "Enbrel is first biologic to receive FDA
approval for the treatment of ankylosing spondylitis." 2003.
www.amgen.com/news/news03/pressRelease030724.pdf (31 July 2003).
Darbepoetin
Alfa Shows Promise With Anemia
An ongoing open-label trial indicates that darbepoetin alfa (Aranesp)
may be an option for treating chemotherapy-induced anemia, but with
less frequent dosing than is required with epoetin alfa (Procrit).
A total of 1,173 patients with nonmyeloid malignancy were studied
as part of the ongoing trial. All participants had a screening hemoglobin
of ²11 gm/dL. Patients received 3 mcg/kg of darbepoetin alfa
every two weeks. The average increase in hemoglobin was 2.1 gm/dL
for those who completed the full 16-week study, and patients' energy
level, as measured by a functional assessment score, increased by
26%. Injection site pain was the most common adverse event. In addition,
six subjects experienced deep vein thrombosis, five had pulmonary
embolism, and four had treatment-related hypertension. Researchers
say that the two-week regimen of darbepoetin alfa was comparable
in efficacy to weekly and three-times-weekly regimens of epoetin
alfa for chemotherapy-induced anemia in cancer patients.
Vadhan-Raja, S., Mirtsching, B., et al. 2003. Assessment of hematologic
effects and fatigue in cancer patients with chemotherapy-induced
anemia given darbepoetin alfa every two weeks. J Support Oncol,
1(2), 1. Amgen. "A powerful treatment: Aranesp (darbepoetin
alfa). 2003. www.aranesp.com/patient/anemia_chemo/treatment/index.jsp
(4 Aug. 2003).
Drug
Roundup
* A boxed warning has been added to labeling for
lindane lotion and shampoo (Kwell, Scabene, others),
because of the increased risk for neurotoxic reactions in
certain patients, especially children and adults under
110 pounds. The drug is a second-line treatment for scabies and
lice, and patients should follow directions meticulously.
* The first test for the West Nile virus has been
cleared by the FDA. The West Nile Virus IgM Capture ELISA (enzyme-linked
immunoassay) detects levels of IgM, an antibody to the disease,
within the first few days of the onset of illness. The blood test,
which can assist in the diagnosis of patients, has been shown to
correctly identify the antibody in at least 90% of patients.
* The first transdermal therapy for overactive bladder
has twice-weekly dosing. Called Oxytrol, the patch
delivers a continuous low dose of oxybutynin HCl at a rate of 3.9
mg/day. The most common side effect is pruritus at the application
site.
OTC
Talk
Another Choice For Heartburn Sufferers The FDA
has approved Prilosec OTC as a treatment for heartburn that occurs
two or more times a week. Each Prilosec OTC delayed-release tablet
contains 20 mg of omeprazole, a gastric acid pump inhibitor. The
dose is one tablet daily, before eating, for 14 days. Patients should
wait four months before taking another 14-day course of the OTC
drug, unless told otherwise by their physician. Side effects are
uncommon, but include headache, diarrhea, constipation, upset stomach,
vomiting, cough, cold symptoms, dizziness, and rash. Although Prilosec
OTC has the same active ingredient as prescription Prilosec, it
is not approved for the treatment of serious gastrointestinal disorders
such as gastroesophageal reflux disease (GERD), esophagitis, or
ulcers. If patients with symptoms of these conditions ask about
Prilosec OTC, explain that it's not intended to treat those diseases,
and advise them to speak to their primary care provider. U.S. Food
and Drug Administration.
"FDA approves Prilosec OTC to treat frequent heartburn."
2003. www.fda.gov/bbs/topics/news/2003/NEW00916.html (23 June 2003).
THE AUTHOR JAMES M. WOOTEN, Pharm D, 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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