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DRUG Watch
Information on drugs, including new approvals and indications, warnings, and other regulatory updates.
NEW DRUGS FOR PREVENTING
MIGRAINES
U The Food and Drug Administra
tion has approved three drugs
from a new drug class designed
to prevent migraine headaches.
The drugs target calcitonin gene-
related peptide, a substance in
volved in the excessive cerebral
vasodilation that leads to mi
graine headaches.
U The three new products are
administered subcutaneously
once per month.
T
he Food and Drug Adminis
tration has approved three
members of a new class of drugs
designed to prevent migraine head
aches and known as calcitonin
gene-related peptide (CGRP) re
ceptor antagonists. The three drugs
are erenumab-aooe (Aimovig),
fremanezumab-vfrm (Ajovy), and
galcanezumab-gnlm (Emgality).
Migraine headaches cause se
vere and debilitating pain that can
be accompanied by nausea, vomit
ing, and heightened sensitivity to
light and sound. Migraines are as
sociated with excessive cerebral va
sodilation, which is now believed
to result from a trigger (such as
stress, certain foods, or hormonal
changes) that sets off a chain of
events originating in the brain-
stem. The brainstem then pro
duces significant atypical dilation
of the cranial blood vessels, which
mechanically activates sensory fi
bers from the trigeminal nerve in
the vessel wall. These activated fi
bers then send pain impulses to
the upper brain, which prompts
the fibers to release vasoactive
substances such as CGRP, which
intensifies vasodilation, leading to
leaky blood vessels. This induces
mast cells to release compounds
that cause more sensory nerve fi
ber stimulation, more release of
CGRP, and more vasodilation.
The primary mechanism of
action of CGRP receptor antag
onists is to block the effects of
CGRP. All three drugs are mono
clonal antibodies. They are de
signed to prevent future migraine
headaches, not to treat current
headaches. All three drugs are
given monthly by subcutaneous
injection (the site of administra
tion did not alter the rate of ab
sorption). Fremanezumab-vfrm
can alternatively be given every
three months (quarterly). Patients
who need a higher dose of ere
numab-aooe may require two in
jections (one given directly after the
other). Prior to starting a monthly
schedule, galcanezumab-gnlm
requires a loading dose of two
injections.
Injection site reactions (such
as pain, redness, and itching) are
the most common adverse effects
of all three drugs. The drugs' la
beling states that hypersensitivity
reactions are possible, but not com
mon. Erenumab-aooe lists consti
pation as an additional common
adverse effect and warns that the
needle cap of the prefilled injector
is made of rubber and could cause
allergic responses in patients with
latex allergies. Otherwise, these
drugs are well tolerated.
All three drugs may provoke
an immune response (immunoge
nicity) causing patients to build
up antibodies against the drugs.
These drugs are broken down
by the same pathways as endoge
nous immunoglobulin G.
Nurses should tell patients to
store these medications in the re
frigerator. They should also teach
patients how to administer these
products as monthly subcutane
ous injections and provide patients
and their families with information
about common site reactions and
how to recognize signs and symp
toms of hypersensitivity reactions.
For specific information on admin
istration techniques or clinical trial
data, see the label for erenumab
aooe at www.accessdata.fda.gov/
drugsatfda_docs/label/2018/761
077s000lbl.pdf, fremanezumab
vfrm at www.accessdata.fda.gov/
drugsatfda_docs/label/2018/7610
89s000lbl.pdf, and galcanezumab
gnlm at www.accessdata.fda.gov/
drugsatfda_docs/label/2018/7610
63s000lbl.pdf.
FDA WARNS OF HIDDEN
PRESCRIPTION DRUGS IN
DIETARY SUPPLEMENTS
U The Food and Drug Administra
tion has issued a warning that
many products sold as dietary
supplements for weight loss, sex
ual enhancement, or body build
ing contain prescription drugs or
other chemicals.
U Nurses and NPs should assess pa
tients for use of these products
and help them recognize those
that are potentially tainted.
P
eriodically, the Food and Drug
Administration (FDA) issues
public notifications about prod
ucts sold over the counter and on
the Internet that, despite being
promoted as dietary or "natural,"
contain hidden prescription drugs.
The most common contaminated
products are those sold for sexual
enhancement, weight loss, and
body building. Weight loss prod
ucts recently found to contain
drugs or chemicals include GoLean
Detox, Ultra Fit, 1 Day Diet, Slim
Bio Capsules, and Slimmer Ex
treme Thermogenic Formula. Sex
ual enhancement products recently
found to include drugs or chemi
cals include Red Stallion Extra
Strong, Natural V=GRA, Yong
Gang, Golden Ant, Instinct Best
Sexual Enjoyment, Black King
Kong, and Nectar Del Amor.
Among the hidden drugs in
weight loss products are drugs that
were removed from the market by
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AJN  May 2019  Vol. 119, No. 5
ajnonline.com