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2003
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A
Non-Stimulating ADHD Drug For
Children And Adults
A new drug for treating attention-deficit/hyperactivity
disorder (ADHD) has been approved for use in children,
adolescents, and adults. Atomoxetine (Strattera), the
first new ADHD therapy in three decades, is also the first
in a new class of drugs called selective norepinephrine
reuptake inhibitors. Unlike existing therapies such as
methylphenidate HCl (Ritalin, Concerta, others), atomoxetine
doesn't act as a stimulant and isn't classified as a controlled
substance. It can be taken once or twice daily. In placebo-controlled
studies, atomoxetine significantly reduced core symptoms
such as hyperactivity/impulsiveness and inattention. The
most common side effects in pediatric patients included
decreased appetite, upset stomach, nausea or vomiting,
and tiredness. In adults, they included difficulty sleeping,
dry mouth, dizziness, and sexual side effects. Detailed
information for professionals and consumers can be found
at www.strattera.com.
U.S. Food and Drug Administration. "FDA
approves a non-stimulant AD/HD drug." 2002. www.fda.gov/bbs/topics/answers/2002/ans01177.html
(10 Dec. 2002).
Eli Lilly and Company. "FDA approves
Strattera, first noncontrolled option for treatment of
attention-deficit/hyperactivity disorder." 2002.
www.strattera.com/cnt_news/pressRelease01.html (12 Dec.
2002).
Asthma
Med Is First In Its Class
For Seasonal Allergic Rhinitis Montelukast sodium (Singulair)-a
drug widely used for the chronic treatment of asthma-is
the first drug in its class to be approved for the treatment
of seasonal allergic rhinitis symptoms. While most oral
allergy medications work by blocking histamine, montelukast
blocks leukotrienes, substances released by various cells,
including mast cells and eosinophils, that are linked
to symptoms in the early phases (sneezing, nasal itch,
runny nose) and late phases (congestion) of allergic rhinitis.
For this use, the drug is approved in patients 2 years
of age and older. In clinical trials for allergic rhinitis,
adverse effects were similar to placebo; montelukast was
not associated with sedation. The most commonly reported
side effects were headache, ear infection, sore throat,
and upper respiratory infection.
Merck & Co. "FDA approves Singulair
for seasonal allergic rhinitis." 2003. www.merck.com/newsroom/press_releases/010203.html
(10 Jan. 2003).
Bone-Forming
Drug Is Approved For Osteoporosis
For the first time, the FDA has approved an osteoporosis
therapy that stimulates new bone formation, though its
use isn't recommended for more than two years. The drug,
called teriparatide (Forteo), is approved to treat osteoporosis
in postmenopausal women at high risk for fracture and
to increase bone mass in men with primary or hypogonadal
osteoporosis at high risk for fracture. Once-daily injections
of teriparatide plus calcium/vitamin D supplements significantly
stimulated new bone formation and increased bone mineral
density at the spine and hip, compared to supplements
alone. It also reduced the risk of fractures in postmenopausal
women. In preclinical tests, teriparatide increased the
incidence of osteosarcoma in rats given doses three to
60 times higher than the recommended 20 mcg per day human
dose; the incidence was related to dose and duration.
Because the risk in humans is not known, the labeling
carries a "Black Box" warning, and the drug
is contraindicated in patients at increased risk of osteosarcoma,
such as those with growing bones, Paget's disease, or
a history of cancer involving the bones.
U.S. Food and Drug Administration. "FDA
approves teriparatide to treat osteoporosis." 2002.
www.fda.gov/bbs/topics/answers/2002/ans01176.html (9 Dec.
2002).
Eli Lilly and Company. "FDA approves
Lilly's first-in-class treatment for osteoporosis patients."
2002. http://newsroom.lilly.com/news/story.cfm?id=1143
(9 Dec. 2002).
A
New Weapon To Aid Kids With
Parasite-Induced Diarrhea
The FDA has approved a new, three-day treatment for children
1 - 11 years of age with diarrhea caused by infection
with the two most common waterborne protozoa in the United
States: Cryptosporidium parvum and Giardia lamblia. The
drug, nitazoxanide (Alinia) oral suspension, is the first
agent approved for treating Cryptosporidium. Both parasites
can cause diarrhea lasting for weeks. In studies, the
most common side effects of nitazoxanide (abdominal pain,
diarrhea, vomiting, and headache) occurred at rates comparable
to placebo. The drug's safety and efficacy have not yet
been established in patients who are HIV-positive or immunodeficient.
U.S. Food and Drug Administration. "FDA
approves new treatment for parasitic infections in pediatric
patients." 2002. www.fda.gov/bbs/topics/answers/2002/ans01178.html
(12 Dec. 2002).
Claritin
Goes Over-The-Counter
With Five Formulations
The antihistamine loratadine (Claritin) is now available
as an OTC product for seasonal allergic rhinitis in five
formulations, all at prescription strength: once-daily
tablets; once-daily tablets that dissolve orally without
water (Claritin RediTabs); a syrup for use in children
2 and older; and 12- and 24-hour extended-release formulations
of Claritin-D, which contains the decongestant pseudoephedrine
HCl. Loratadine was among the first of a new generation
of antihistamines designed to be less sedating at recommended
dosages than conventional antihistamines, such as diphenhydramine
HCl (Benadryl) or triprolidine HCl (Actifed). Unlike such
products, loratadine isn't required to carry a warning
about drowsiness or restrictions on driving.
U.S. Food and Drug Administration. "FDA
approves OTC Claritin." 2002. www.fda.gov/bbs/topics/news/2002/new00855.html
(11 Dec. 2002).
Drug
Roundup
* A safer smallpox vaccine? VaxGen, Inc., will initiate
U.S. clinical trials involving a vaccine used in Japan.
In a study there, 50,000 children were immunized, with
"no serious side effects ... observed," according
to a company news release. * Prozac (fluoxetine HCl) is
now approved for treating major depression and obsessive-compulsive
disorder in children and adolescents, ages 7 - 17. A post-marketing
study will evaluate the potential effect on long-term
growth. * Other new FDA approvals: Cyclosporine ophthalmic
emulsion (Restasis), 0.05%, for treating patients whose
tear production is suppressed due to keratoconjunctivitis
sicca (chronic dry eye disease); and azelaic acid (Finacea
Gel) 15%, for mild to moderate rosacea.
Pain
Clinic
Depression Can Complicate A Pain Patient's Care
Q A 35-year-old woman with chronic neck
pain develops depression and is put on a selective serotonin
reuptake inhibitor (SSRI). At a recent visit, she says
her life's gotten worse because she's lost her "sexual
response" since going on the drug. She wants to stop
it. What can you suggest? A Take a very careful history
related to her com plaint, and help her understand that
depression is common in patients with chronic pain and
that it's important to treat it. Note also that sexual
dysfunction can indeed be a drug side effect. In a recent
study of more than 6,000 patients on the newer antidepressants,
researchers found that SSRIs (a class that includes Paxil,
Prozac, and Zoloft) were more likely to cause sexual side
effects than an antidepressant like bupropion (Wellbutrin).
If the SSRI is the likely cause of her complaint, tell
her that she has options, including a lower dose of the
SSRI or a switch to another agent.
Source:
Clayton, A. H., Pradko, J. F., et al. (2002). Prevalence
of sexual dysfunction among newer antidepressants. J Clin
Psychiatry, 63(4), 357. THE AUTHOR MARY SCHOLZ, RN, BSN,
MS, PhD, is a nurse clinician and behavioral medicine
specialist at Northwest Psychophysiology, an affiliate
of Northwest Neuroscience Institute in Seattle.
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