FDA Requests Boxed Warning for Contrast Agents
Used to Improve MRI Images
The
U.S. Food and Drug Administration (FDA) has asked manufacturers to include a
new boxed warning on the product labeling of all gadolinium-based contrast
agents.
The
warning would state that patients with severe renal insufficiency who receive
gadolinium-based agents are at risk for developing a potentially fatal disease
known as nephrogenic systemic fibrosis (NSF).
Patients
with NSF develop thickening of the skin and connective tissues that inhibits
their ability to move and may result in broken bones. The cause of NSF is not
known and there is no effective treatment yet.
The
FDA first put out warnings about the gadolinium-related risks for NSF in June
2006, made updates in December, and now decided on the boxed warning.
Five
gadolinium-based contrast agents are currently used in the
Reports
have identified the development of NSF following single and multiple doses. There have been no reports of NSF among
patients with normal kidney function or those with mild-to-moderate kidney
insufficiency.
What is
Ranexa?
We have had a couple instances where cardiologists have ordered
and we have started patients on Ranexa
(ranolazine) for chronic angina in the emergency department.
Conventional angina drugs reduce cardiac oxygen demand and may
also increase blood flow. Ranexa works differently. It's a metabolic
modifier. It helps heart cells generate
energy more efficiently allowing the heart to function despite a decreased
oxygen supply. But it's not a miracle drug. Patients using Ranexa have
about one less angina episode a week. And it's less effective in women than in
men.
Ranexa will be add-on therapy for patients who don't get enough benefit
from nitrates, beta-blockers, and calcium channel blockers.
It's also an option for patients who can't take full doses of conventional
angina drugs due to low blood pressure and heart rate. Ranexa doesn't
lower BP and heart rate like the others.
Ranexa is NOT for initial therapy because it can increase the QT
interval and therefore, increase the risk of arrhythmias. Ranexa is
contraindicated with other drugs that can also increase the QT interval such as
amiodarone, erythromycin, quinidine, and sotalol. Arrhythmia risk also
increases if Ranexa is combined with CYP3A4 inhibitors such as diltiazem
and verapamil.
Recommend amlodipine (Norvasc) for patients who need to use a
calcium channel blocker with Ranexa. Amlodipine doesn't inhibit CYP3A4. Dosing range of Ranexa is usually
500-100mg twice daily.
CMC Drug
Error Report …
Some examples of errors or near
misses that have been reported by you:
ü
Avelox
order sent to Rx. Delay was greater than an hour. RN not aware drug stocked in
Omnicell, Rx assumed it was dispensed from Omnicell
ü
Zithromax
ordered 20mg/kg instead of 10mg/kg
ü
Patient’s
home med Ranexa ordered after Erythromycin was ordered for pneumonia.
ü
Rocephin
dose calculated using incorrect patient weight. RN realized wrong weight was
entered in triage and stopped infusion half way through.
Please continue to report any error(s) you
encounter or make, or any near miss.
Remember this is completely anonymous
Just A Reminder…
Ø
Please
remember to place the PCA keys back in the omnicell.
Ø
In
last month’s newsletter there was an article about the titration of
Nitroglycerin. The purpose of that was to reinforce the proper way of
calculating the mean arterial pressure (MAP).
There may be instances where a physician would want a greater than 20%
drop. In those cases, they will inform
the nurse of what their goal is based on the patient’s condition.
May
5/6 Becky Passananti,
Rodrigo Sanchez
5/8 Lawana Hudson, Kim
Foley
5/11 Madonna Scatena,
Elizabeth McClelland
5/13 Lisa Brown
5/15 Tracy Styx
5/21 Melita Kissley
5/22 Bill Papoutsis
5/24 Lisa Hofstra
5/26 Nikki Nino
5/29 Jennifer Conway
v
2006 SAEM Resident Presentation of the Year: Greg Roslund,
Terri Hepps, Kate McQuillin for Zofran and peds GE.
v
Runner-up 2006 CPC Competition:
Andrej Urumov.
v
Finalist 2007 AAEM Residency Research Competition: April Bisaga,
Kate Paquette, and Elise Lovell for CA-MRSA in the ED.
v
2007 Dimensions of Excellence 1st prize (for best poster): Bisaga,
Paquette, & Lovell’s CA-MRSA in the ED.
v
ICEP 2007 Best Poster: Hannah Watts, Karis Tekwani,
Kathy Rzechula, Erik Kulstad, for Alpha Blockade in Kidney Stones.
v
EMRA’s 2007 Robert J. Doherty, MD Teaching
Fellowship Scholarship: Christine Kulstad.
v
EMRA 2007 Associate Residency Director Award: Dan Girzadas,
Jr.
v
Annals of Emergency Medicine, July 2007 will name as a
Senior Editor:
Erik Kulstad.
Please forward any news or announcements via email or
IBEX to Rolla Sweis.
Any questions or comments please
send to:
Andrea Carlson, MD
acarlsonmd@comcast.net
rogu@alum.mit.edu
Rolla Sweis, PharmD
Rolla.Sweis@advocatehealth.com