Transcript Top 10 Drugs Used Off Label and 10 Drugs That

TOP 10 DRUGS USED OFF
LABEL AND 10 DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE
Colonel Randall G Hoeppner CRNA CRNP FNP
Chief of Anesthesia Services PRMC
BUT FIRST A WORD FROM OUR
LEGAL DEPARTMENT!
I have no relationship with any pharmaceutical
companies nor have I received any honorary from any
source
The information presented is not the opinion of anyone
other than myself.
Due diligence, standard of care, evidence based
medicine, and the five rights: Patient, Drug, Dose, Time,
and Route must never be deviated or compromised
MORE LEGAL STUFF
My opinions are strictly mine and do not represent
the opinions of the Federal Government, the United
States army, or any hospital or educational
institution.
I am NOT a RECRUITER……YES YOU CAN TALK TO
ME!! This activity counts as a drill for me and that’s
that!!!!
WE NEVER HEAR THESE
PATIENT
OBSERVATIONS:
I don’t like to take medications
because I don’t want to put
chemicals in my body that’s why I
only take all natural medications
from the health food store.
I take a blue pill. A red pill, and a
speckled pill but I don’t know why my
doctor put me on those.
Fill in the blank for any I missed!!!
WHERE MEDICINE
COMES FROM
This is where “All Natural”
preparations come from as well…..
OFF LABEL USE IS THE USE OF PHARMACEUTICALS FOR AN UNAPPROVED
INDICATION OR IN AN UNAPPROVED AGE GROUP, DOSAGE, OR ROUTE
OF ADMINISTRATION BOTH PRESCRIBED AND OTC DRUGS MAY BE USED
OFF LABEL ALTHOUGH MOST STUDIES FOCUS ON PRESCRIPTION DRUGS.
The Agency for Health Care Research and Quality a division of the
Health and Human Services estimates that 1 in 5 prescriptions are
for off label use.
10 Most Prescribed Drugs
in the USA
Top 10 Drugs by Sales

1) Synthroid (levothyroxine)

1) Humira (Adalimumab) 8.2 billion

2) Crestor (rosuvastatin)***

2) Abilify (Aripiprazole) 7.9 billion

3) Ventolin HFA (Albuterol)

3) Sovaldi (Sofosbuvir)6.9 billion

4)Nexium (esomeprazole)***

4) Crestor (Rosuvastatin) 5.9 billion ***

5) Advair Diskus (Fluticasone)***

5) Enbrel(Etanercept) 5.9 billion

6)Lantus Solostar (Insulin Glargine)***

6) Harvoni (Ledipasvir/Sofosbuvir) 5.3 billion

7)Vyvanse (Lisdexamfetamine)

7) Nexium (esomeprazole) 5.3 billion ***

8) Lyrica (Pregabalin)

8) Advair Diskus (Fluticasone) 4.7 billion ***

9) Spiriva Handihaler (Tiotropium)

9) Lantus Solostar (Insulin Glargine)4.7 billion ***

10) Januvia (Sitagliptin)

10) Remicade (Infliximab) 4.6 billion
DATA FROM THE CENTERS FOR
MEDICARE AND MEDICADE SERVICES
DRUG
INDICATION
OFF LABEL
Synthroid(Levothyroxine)
Hypothyroidism
Depression in tandem
with anti-depressants
Vyvanse
(Lisdexamfetamine)
ADHD
Depression,
Schizophrenia,
Narcolepsy, Binge
Eating Disorder
Lyrica (Pregabalin)
Neuropathic pain
seizures
Anxiety, GAD, Preoperative oral
medication
Abilify (Aripiprazole)
Schizophrenia Bipolar
Disorder
Insomnia
Namenda
(Memantine)
Dementia Alzheimer's
Disease
ADHD OCD (children)
DRUG
INDICATION
OFF LABEL
Prazosin (Minipres)
Hypertension
Nightmares related to
PTSD, Raynaud's,
Scorpion Venom
Poisoning
Clomiphene (Clomid)
Female Infertility due
to ovulatory disorder
Male Infertility (3
month trial improved
sperm count, motility,
and morphology
Clonidine (Catapres)
Hypertension
Cancer Pain, Nicotine
Dependence, Opioid
Withdrawal, Migraine
Headaches, RLS
Quetiapine(Seroquel)
Schizophrenia Bipolar
Disorder
Chronic Insomnia (NIH
advises not to use)
Naltrexone(Revia)
Alcohol/Opioid
Dependence
Impulse Control
Disorder (Gambling,
Kleptomania,
Tricotillomania

In the case of Naltrexone there is some
belief that low dose naltrexone may benefit
the treatment of cancer, HIV, and MS by
normalizing the immune system however
current data is lacking.

Ketamine is being used via Epidural in
Japan for chronic pain syndromes and
reflex sympathetic dystrophy. In addition
Ketamine is being used for severe
depression with less suicidal ideations whilst
SSRI and SNRI are reaching therapeutic
windows.

Clonidine and Precedex
(Dexmedetomidine)is being used in spinal
anesthesia for regional anesthesia including
C-Sections.
BONUS DRUGS BEING
USED OFF LABEL
AND YOU THOUGHT
YOU HAVE TROUBLES!!!
Remember the risk benefit ratio if
the benefits out weigh the risks
then its appropriate to give the
medication. If the risks outweigh
the benefits then consider other
treatments and refer to specialists
when a problem cannot be
handled readily.

1)Warfarin (Coumadin) Presently used for
control of Atrial Fibrillation evidence points
to its value in Hypertensive Heart Disease.
The European Journal of Heart Failure in a
Retrospective , Longitudinal Cohort Study of
2,619 patients found a 28 percent reduction
in mortality after three years. The study
group consisted of patients with Left
Ventricular Systolic Dysfunction and
Pulmonary Hypertension. (LVSD PH)
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE
TOP TEN DRUGS THAT
SHOULD BE STUDIED
FOR OFF LABEL USE

2) Aripiprazole (Abilify) primarily used for the
treatment of schizophrenia and
schizoaffective disorder. Aripiprazole
balances two key brain neurochemicals
serotonin and dopamine. There is evidence
that Aripiprasole is effective in treating
Alzheimer's patients who exhibit psychotic
symptoms

3) Atorvastatin (Lipitor) is an HMG-CoA
Reductase inhibitor used to lower LDL or
bad cholesterol. Atorvastatin also lowers fat
by blocking the liver’s ability to produce
cholesterol. Laboratory evidence shows that
cholesterol produced neurotoxins may
precipitate Alzheimer's disease. In clinical
trials Atorvastatin was given to patients with
mild to moderate Alzheimer's disease vs
placebo. The Atorvastatin group
demonstrated improved scores in cognition
however these results were deemed
clinically insignificant but researchers remain
hopeful that further studies may
demonstrate symptom improvement
TOP TEN DRUGS THAT
SHOULD BE STUDIED
FOR OFF LABEL USE

4) Simvastatin is a cholesterol lowering
medication made from a fungus Aspergillus
Terreus. It works by inhibiting 3-hydroxyl-3methylgluteral (HMG) coenzyme A
reductase pathway responsible for the
production of cholesterol. Whilst not
reducing triglycerides as fibrates do
Simvastatin reduces cardiovascular disease
irrespective of the initial cholesterol
concentration a truly pleiotropic effect.
Interestingly, Some unexpected effects on
the immune system prompted study on MS
with Simvastatin. In a study of 30 patients
with relapsing-remitting MS a six month
course of Simvastatin reduced lesions seen
in MRI studies by 44 percent. Studies are on
going to determine how the
immunomodulation effects of Simvastatin
work
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE

5) Topiramate(Topamax) is an
anticonvulsant used for epilepsy and
prevention of migraine headaches.
Topamax modulates the Gamma Amino
Butyric Acid neurotransmitter in the brain.
Topamax has a neuro protective function
which led it to trials for MS patients who
experience paroxysmal symptoms
especially trigeminal neuralgia, painful
spasms, dysesthetic or paresthetic
symptoms In a 13 patient trial increasing
doses of Topamax were given until they
responded optimally. 3 patients dropped
out due to persistent nausea. The remaining
patients responded to treatment but did not
achieve remission. Further study is
warranted.
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE

6) Donepezil (Aricept) is a cholinesterace
inhibitor thereby increasing acetylcholine in
the brain. Based on Aricept’s modest
slowing of Alzheimer’s disease progression
Aricept is being used in TBI. The University of
Texas health Science Center in San Antonio
Texas examined 18 patients with acute TBI in
a 24 week trial. The A Group of 9 patients
received Aricept for the first 12 weeks and
a placebo for 12 weeks thereafter. The B
group of 9 patients had placebo for 12
weeks and Aricept for 12 weeks thereafter.
In cognitive testing the early Aricept
recipients had vastly improved test scores in
cognition and short term memory.
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE

7) Colchicine (Cholcrys) is a toxic natural
product extracted from plants of the genus
Cholchicum autumnale also known as
meadow saffron. It is used to treat gout,
familial Mediterranean fever, pericarditis,
Bechet's Disease and atrial fibrillation.
Basically Colchicine acts as a mitotic poison
and neutrophil motility yielding a net antiinflammatory effect. It was described in the
Ebers Papyrus and used around 1500BC
Colchicine In a Spanish study of nine
patients with recurrent pericarditis those
treated with Colchicine had no recurrence
of pericarditis in a two year follow up.
TOP TEN DRUGS THAT
SHOULD BE STUDIED
FOR OFF LABEL USE

8) Theophylline is a methylxanthine
structurally and pharmacologically similar to
theobromines and caffeine. It is primarily
used in respiratory diseases including COPD
and asthma. It is used in infants and small
animals as well. It is a positive inotrope and
chronotrope. Canadian researchers at
Childrens Hospital at Winnipeg recently
studied 9500 children with Cystic Fibrosis 75
percent of these patients were using
inhaled bronchodilators which remains
controversial. Researchers believe that
Theophylline may reverse steroid resistance
and may be a better first line therapy for CF
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE

9) Imiquimod (Aldara) is an immune
response modifier used in the treatment of
genital warts, superficial basal cell
carcinomas and actinic keratosis its method
of action is the activation of the toll like
receptor 7 (TLR-7) which releases cytokines
(interferon Alpha, Interleukin 6, and tumor
necrosing factor alpha. In a clinical trial
(aldara) five percent cream was used to
treat Hemangioma on ten children with
within a 16 week treatment 4 had complete
disappearance of the hemangioma 3 had
excellent clinical response 1 had moderate
clinical response and 1 had no response. 9
of 10 avoided having surgical removal of
the hemangioma.
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE

10) Prazosin (Minipres) is an antihypertensive
of the alpha blocking class which relaxes
blood vessels and decreases circulatory
resistance. In addition it relaxes the trigone
muscle of the urethra and BPH. Lately,
Prazosin is being used to quell PTSD
nightmares in a 2012 study it showed a
small but positive benefit in treatment of
night terrors in adults.
TOP TEN DRUGS THAT
SHOULD BE INVESTIGATED
FOR OFF LABEL USE
WHO IS THIS AND WHY
IS SHE FAMOUS?
FRANCES OLDHAM
KELSEY CM
Was a Canadian physician reviewer for the
FDA she turned down under intense pressure
the application for thalidomide in the US. The
drug was developed and marketed in
Germany in 1956 for use as a sedative
hypnotic as well as for Nausea and Vomiting
of Pregnancy (NVP) Approximately 10,000
babies were born with devastating defects of
the limbs, eyes, hearts, and gastro-intestinal
tract. This led to a much more vigorous clinical
trial and over watch of medications being
developed and marketed in the US and other
countries.
OFF TOPIC BUT WHO IS
THIS AND WHY DO WE
OWE HER SO MUCH?
This pioneer never realized her
contribution to the world of
medicine, genetics, forensic
science, and to the development
of vaccines, Nano technologies
and the betterment of lives all over
the world
HENRIETTA LORETTA
PLEASANT LACKS
Born 1 August 1920 in Roanoke Virginia Died 4
October 1951 age 31 years. Monuments
include the Henrietta lacks Health and
Bioscience High School and a historical marker
at Clover Virginia.
Mrs. Lacks was the unwitting donor of her
cancerous cells from her cervix. These cells
were cultured at John Hopkins in Baltimore
Maryland and cultured by George Otto Gey
to create the first immortal cell line now known
as the HeLa cell line which is still used for
medical research.