News & Analysis
News From the Food and Drug Administration
Domestically Produced Radioisotope
The FDA and the Nuclear Regulatory Com-
mission (NRC) have collaborated to estab-
lish a stable, domestic supply of the most
widely used radioisotope in medical imaging.
TechnetiumTc99m(99mTc),whichisused
in more than 40 000 imaging procedures
daily in the United States, helps in diagnos-
ing heart disease, cancer, infection, and in-
flammation. However, it’s often in short sup-
ply because of a complex supply chain.
Technetium Tc 99m is the decay product of
molybdenum 99 (99Mo), which is produced
from highly enriched uranium. Because all of
the reactors used in the production process
are outside of the country, the United States
shipped enriched uranium to those facilities
and the resulting 99Mo was shipped back.
Those procedures created a “compli-
cated, at times uncertain, and potentially
risky supply chain,” FDA Commissioner Scott
Gottlieb, MD, said in a statement. “Because
of frequent supply disruptions—or even the
threat of disruptions—clinicians have shifted
to alternative isotopes that may be more ex-
pensive or may expose patients to higher
doses of radiation.” Supply disruptions oc-
curred in 2009 and 2010, Gottlieb noted.
Since Congress passed the American
Medical Isotopes Production Act in 2012,
the US Department of Energy has worked
with the private sector to support projects
that could produce 99Mo domestically for
medical purposes without using highly
enriched uranium. A broad collaboration
between additional federal agencies and
industry led to the development of the
RadioGenix System, which produces 99Mo
without highly enriched uranium and gen-
erates sodium pertechnetate 99mTc as a
clear, colorless solution given by injection.
Sodium pertechnetate 99mTc is a radio-
active diagnostic agent used in preparing
FDA-approved diagnostic radiopharmaceu-
ticals. It also is indicated for use in adults for
salivary gland imaging and nasolacrimal
gland drainage system imaging and in adult
and pediatric patients for thyroid imaging
and urinary bladder imaging.
The FDA has approved the RadioGenix
System and the NRC will license it and issue
guidance for its use in medical procedures.
1086 JAMA March 20, 2018 Volume 319, Number 11 (Reprinted)
© 2018 American Medical Association. All rights reserved.
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Smart Watch Detects Seizures
The first smart watch used to monitor sei-
zures has received FDA approval. Marketed
under the name Embrace, the watch uses
advanced machine learning to detect grand
mal or generalized tonic-clonic seizures and
to alert a caregiver for help.
The technology senses movement and
electrical fluctuations in the skin that may be
associated with seizures in people who have
epilepsy. When a seizure is detected, the
watch sends a command to a paired wire-
less device that’s programmed to alert a des-
ignated caregiver. The watch records and
stores data that a health care professional
can review. The device also analyzes sleep,
rest, and physical activity. It was approved
last year in Europe as a seizure-monitoring
medical device.
In a trial, researchers used continuous
video electroencephalography (EEG) to
monitor 135 patients with epilepsy who
wore the watch. Over 272 days, researchers
gathered 6530 hours of data that included
40 generalized tonic-clonic seizures. Com-
pared with seizures that independent
experts documented from video-EEG data,
the watch’s algorithm detected 100% of
the seizures.
The watch “offers the potential to alarm
family members and caretakers that
a tonic-clonic seizure is occurring,” Orrin
Devinsky, MD, director of New York Univer-
sity Langone Health’s Comprehensive
Epilepsy Center, said in a statement. “The
scientific evidence strongly supports that
prompt attention during or shortly after
these convulsive seizures can be life-saving
in many cases.”
The FDA’s approval was granted to
Empatica Inc of Cambridge, Massachusetts,
which is spin-off of the Massachusetts Insti-
tute of Technology Media Laboratory.
New Treatment Option for Pneumonia
The FDA has approved a third indication for
a fixed-dose combination of ceftazidime
and avibactam to treat adults with hospital-
acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia
(HABP/VABP).
The newest indication is for HABP/
VA B P c a u s e d by s u s c e p t i b l e g ra m -
negative bacteria including Klebsiella
pneumoniae, Enterobacter cloacae, Esch-
erichia coli, Pseudomonas aeruginosa, and
Haemophilus influenzae.
“Health care professionals have not had
access to a new treatment option for pa-
tients with HABP/VABP due to gram-
negative bacteria in over 15 years,” David
Nicholson, PhD, chief research and devel-
opment officer at Dublin, Ireland-based
Allergan plc, said in a statement. Allergan
holds North American rights to the drug.
Marketed as Avycaz, the combination
drug was first approved in 2015 in combi-
nation with metronidazole for adults with
complicated intra-abdominal infections.
Last year, approval was expanded to treat
complicated urinary tract infections,
including pyelonephritis, caused by certain
gram-negative bacteria.
Approval of a third indication was
based on results from a phase 3 trial
involving 870 hospitalized adults with
HABP or VABP. They received either Avy-
caz or meropenem given intravenously
every 8 hours for 7 to 14 days.
The primary end point was the 28-day all-
cause mortality rate. Among patients treated
with Avycaz, the rate was 9.6% compared
with 8.3% in the meropenem group. The
most common adverse reactions were diar-
rhea and vomiting.
Bruno Gallizzi/Empatica, Inc.
Avibactam is a non-β-lactam β-lacta-
mase inhibitor that protects ceftazidime, a
cephalosporin, from degradation by certain
β-lactamases. − Rebecca Voelker, MSJ
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