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Health
Authorities Promise To Act Fast On Ephedra
The Department of Health and Human Services and the FDA
are reviewing new evidence on risks associated with ephedra
and may soon require a warning label on products containing
the herb. Ephedra, also known as ma huang, is used in
certain supplements claiming to help with weight loss
and boost energy.
A
new review of 16,000 reports of adverse events associated
with ephedra revealed two deaths, four heart attacks,
nine strokes, one seizure, and five psychiatric cases
in which no other contributing factors but ephedra were
identified. The proposed label would warn of such risks,
which may be increased by higher doses, strenuous exercise,
and the use of other stimulants (such as caffeine). It
would also state that pregnant or nursing women, individuals
under age 18, and those with certain illnesses or taking
certain medications should not use products containing
ephedra. (See page 23 for more on the risks of ephedra.)
U.S.
Food and Drug Administration. "HHS acts to reduce
potential risks of dietary supplements containing ephedra."
2003. www.fda.gov/bbs/topics/news/2003/new00875.html (5
Mar. 2003).
New
Rheumatoid Arthritis Drug Helps Slow Structural Damage
Rheumatoid arthritis (RA) sufferers who are not being
helped by disease-modifying antirheumatic drugs (DMARDs)
have another advanced option: adalimumab (Humira), the
first fully human-derived monoclonal antibody. Adalimumab
specifically blocks human tumor necrosis factor-alpha
(TNF-alpha), a cell protein involved in inflammatory and
immune responses that is present in elevated levels in
RA patients. The drug is supplied in easy-to-handle prefilled
syringes for patients to inject subcutaneously every other
week.
Adalimumab
is approved for adults with moderate to severe RA who
have had an inadequate response to one or more DMARDs.
It can be used alone or with a DMARD such as methotrexate
(Rheumatrex, MTX). In clinical trials, adalimumab reduced
signs and symptoms of RA in more than half the patients.
In a yearlong trial, patients on adalimumab plus methotrexate
had significantly less joint deterioration than those
on methotrexate alone. TNF-blocking agents, including
adalimumab, etanercept (Enbrel), and infliximab (Remicade),
can cause rare serious and sometimes fatal infections,
including tuberculosis and sepsis. Rare cases of malignancies
of the lymphoid system have also been reported.
U.S.
Food and Drug Administration. "FDA approves new therapy
for rheumatoid arthritis." 2002. www.fda.gov/bbs/topics/answers/2002/ans01186.html
(2 Jan. 2003). Abbott Laboratories. "Abbott Laboratories
receives FDA approval earlier than anticipated for Humira
(adalimumab) for the treatment of rheumatoid arthritis
(RA)." 2002. www.abbott.com/news/press_release.cfm?id=524
(6 Jan. 2003).
Drug
Roundup
*The FDA has proposed a new rule that will require universal,
standardized bar codes on all hospital Rx and OTC drugs,
retail Rx drugs, vaccines, and blood. Following a 90-day
comment period (ending June 12), a final rule will be
issued. It's expected that the final rule will be completed
by end of year and take effect in 2006. *Lamotrigine (Lamictal)
has a new approved use: as add-on therapy in the treatment
of partial seizures in children age 2 years and up. In
a study of pediatric patients already on antiepileptic
drugs, those who also took lamotrigine had a 36% reduction
in the frequency of partial seizures vs. 7% with placebo.
*The maker of the antidepressant Serzone (nefazodone HCl)
has reminded healthcare professionals about the potential
for confusing that brand name with the antipsychotic drug
Seroquel (quetiapine fumarate). Serzone is now dispensed
with a special patient leaflet. Teach patients to recognize
their pills: Serzone is hexagonal in shape, while Seroquel
is round and has the full name on the tablet.
Infants
Face Fewer Injections Thanks To A 5-In-1 Vaccine The FDA
has approved a combination vaccine that protects infants
against five diseases-diphtheria, tetanus, pertussis,
polio, and infection with the hepatitis B virus (HBV).
The combo vaccine, called Pediarix, is recommended as
a three-dose primary series, typically given at about
2, 4, and 6 months of age. It shouldn't be given to infants
under 6 weeks of age or to children age 7 or older; nor
should it be used in infants born to mothers who are HBV-positive
or of unknown HBV status, since different immunization
recommendations apply.
The
three-dose series of Pediarix was compared with separately
administered HBV, polio, and diphtheria-tetanus-pertussis
(DtaP) vaccine-a regimen that involves nine injections.
Immune responses were found to be generally comparable
between the two groups. The most common adverse effects
with Pediarix were local injection site reactions (pain,
redness, swelling), fever, and fussiness.
U.S.
Food and Drug Administration. "New pediatric combination
vaccine approved." 2002. www.fda.gov/bbs/topics/answers/2002/ans01181.html
(3 Jan. 2003). GlaxoSmithKline. "FDA approves GlaxoSmithKline's
Pediarix. First U.S. combination vaccine to protect infants
against five diseases." 2002. www.gsk.com/press_archive/press_12132002.htm
(3 Jan. 2003).
These
Two Psych Drugs Should Not Be Taken Together
A new contraindication has been added to the labeling
for sertraline HCl (Zoloft), one of the most widely used
selective serotonin reuptake inhibitors (SSRIs). A study
found that co-administration of 200 mg of sertraline and
a single 2 mg dose of the antipsychotic drug pimozide
(Orap) raised pimozide concentrations by about 40%.
Although
no EKG changes were observed in these patients, pimozide
has a narrow therapeutic window and can cause dangerous
adverse effects, including prolonged QT intervals, ventricular
arrhythmias, and sudden cardiac death. The study used
a small dose of pimozide, but labeling allows titration
of up to 10 mg/day, which would potentially raise the
risk of adverse events due to an interaction with sertraline.
U.S.
Food and Drug Administration. MedWatch. "Zoloft (sertraline
hydrochloride)." 2002. www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zoloft
(16 Jan. 2003).
OTC
Talk
Medicine Cabinet Staples Are Not Without Risk A recent
survey released by the National Consumers League (NCL)
points to the need for nurses and other healthcare providers
to educate consumers about OTC pain relievers. The survey
of 4,263 adults found that of the 84% who used an OTC
pain reliever over the past year, 44% reported exceeding
the recommended dose. And 80% said they hadn't discussed
key risks associated with such products with a healthcare
professional.
Consider,
for instance, OTC nonsteroidal anti-inflammatory drugs
(NSAIDs), which include ibuprofen (Advil, Motrin), naproxen
sodium (Aleve), and ketoprofen (Actron, Orudis KT). Serious
side effects include the risk of GI bleeding and GI ulceration,
hypertension, fluid and water retention, and renal dysfunction.
Such risks are higher in the elderly and in those who
take these drugs for long periods of time; the risks are
also increased among users who routinely exceed the recommended
dosage or are heavy consumers of alcohol.
Remind
your patients that no OTC analgesic-including old standbys
like aspirin (which is similar to NSAIDs) and acetaminophen-is
without risk. Tell patients to read the labels and discuss
their questions with a healthcare professional. Sources:
1. National Consumers League. "New survey reveals
uninformed consumers taking dangerous risks with OTC painkillers."
2003. www.nclnet.org/otcpain/jan30release.htm (4 Feb.
2003). 2. Mayo Clinic. "Nonsteroidal anti-inflammatory
drugs (NSAIDs)." 2002. www.mayoclinic.com/invoke.cfm?id
=pn00038 (12 Feb. 2003).
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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