Download Recent FDA-Approved Drugs 2001

Kee & Hayes: Pharmacology: A Nursing Process Approach, 4th edition
Content Updates
Recent FDA-Approved Drugs
New Drugs 2001-2002
FDA new drug approval list is available weekly by CDER's Division of Data Management and
Services on www.fda.gov/cder/da/da.htm.
colesevelam (Welchol)
This is a bile acid sequentrant that lowers LDL and cholesterol. It is prescribed for
clients/patients who can not tolerate statin drugs. It is used as adjunctive therapy to diet and
exercise.
desloratadine (Clarinex)
A non-sedating antihistamine for treatment of seasonal allergic rhinitis.
norelgestromin/ethinyl estradiol (Ortho Evra)
Ortho Evra is a birth control patch (transdermal system) with hormones similar to those in birth
control pills. The contraceptive patch delivers norelgestromin 150 ug and ethinyl estradiol 20 ug
daily to the systemic circulation. A prescription is required. The patch works by suppressing
ovulation. Ovulation usually returns within 6 weeks of stopping the use of the patch. This patch
is 99% effective in preventing pregnancy when used correctly.
Dosing schedule for the contraceptive patch is 4 weeks (28 days). The woman applies a new
patch each week for the first 3 weeks; followed by a patch-free week, completing the 4 week
cycle. Hormones continue to be released after 7 days; thus back up contraception is not needed if
one forgets to change the contraceptive patch for up to 48 hours. Withdrawal bleeding is
expected to begin during week 4 of no patch use.
Apply contraceptive patch to the abdomen, buttock, upper outer arm or upper torso (not breasts).
Apply patch to a new location on skin. Bathing, exercising, showering, swimming, and humidity
should not affect your contraceptive patch. To remove the patch, lift up at comer and peel back.
Fold in half so it sticks to itself before discarding (patch still has active hormones).
The most frequent side effects are: breast symptoms, headache, application site reactions, nausea,
cramps, and abdominal pain. Potentially life threatening effects are: blood clots, stroke or heart
attack. Cigarette smoking increases risk of serious cardiovascular side effects especially in
women >35 years.
Copyright © 2003, Elsevier, Inc. All rights reserved.
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tazarotene (Tazorac)
Topical acetylinic retinoid for treatment of acne. It is available as a 0.1% gel and cream. May
cause erythema, dryness, scaling, burning, and pruritus.
triptorelin pamoate (Trelstar)
An agonist analog of human luteinizing hormone-releasing hormone (LHRH) for parenteral
treatment of advanced prostate cancer.
Copyright © 2003, Elsevier, Inc. All rights reserved.