Aripiprazole (Abilify).

 This atypical antipsychotic is indicated for the treatment

of various mental health and mood disorders, including schizophrenia,
depression, and bipolar disorder. However, aripiprazole increases the risk of
suicidal thoughts and behaviors in pediatric patients and young adults taking
antidepressants, and increases the risk of death in elderly patients with
dementia-related psychosis. Of note, aripiprazole is not indicated for the
treatment of dementia-related psychosis, but has a history of off-label use for
the treatment of dementia. Furthermore, although not included in the boxed
warning, the FDA warned that the drug could cause impulse-control problems,
such as binge eating and compulsive gambling, in May 2016. More than 2,700
patients who experienced these extreme compulsive behaviors have
filed lawsuits.
Dabigatran etexilate mesylate (Pradaxa). This commonly prescribed
anticoagulant is indicated for the prevention of strokes in patients with atrial
fibrillation, deep vein thrombosis, and pulmonary embolism. While dabigatran
has been shown to increase the risk of serious bleeding during use, the drug’s
boxed warning indicates that premature discontinuation may increase the risk of
thrombotic events, such as stroke or myocardial infarction (MI), due to blood
clots.
Canagliflozin (Invokana). A third-line medication to metformin, canagliflozin is
prescribed to treat type 2 diabetes along with diet and exercise, and reduce the
risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes.
However, a recent boxed warning has indicated that patients with type 2
diabetes who have established CV disease (CVD) or are at risk for CVD may be at
increased risk for lower limb amputation, specifically the toe, midfoot, and leg.
To date, over 1,000 lawsuits have been filed.
Febuxostat (Uloric). Indicated for the chronic management of hyperuricemia in
adults with gout, Febuxostat received a black box warning in February 2019,
alerting prescribers and patients of the higher rate of CV mortality associated
with the drug’s use compared with allopurinol, its most common competitor.
Dextroamphetamine-amphetamine (Adderall). This CNS stimulant is
commonly used for the treatment of ADHD. Researchers have shown, however,
that it is frequently used recreationally by college students and other young
adults for its effects on improved concentration/focus, and also have
demonstrated an association of the drug’s use with addictive behavior. In
addition to the known side effects of sleep disruption and increased risk for
mental health problems—including depression, bipolar disorder, and aggressive
or hostile behavior—there are also CV risks such as high blood pressure and
stroke, as well as the potential for drug abuse and dependence, which have
warranted a black box warning.
Alprazolam (Xanax).This sedative is used primarily for the treatment of anxiety
disorders, is contraindicated in patients with glaucoma, and should never be
used in patients with a history of drug abuse due to its addictive potential.
Alprazolam’s boxed warning advises that concomitant use with opioids, alcohol,
or other CNS depressants may cause severe sedation, respiratory disorders,
coma, and even death. In a 2017 safety communication, however, the FDA stated
that buprenorphine and methadone should not be withheld from patients
taking benzodiazepines or other drugs that depress CNS:
“The combined use of these drugs increases the risk of serious side effects;
however, the harm caused by untreated opioid addiction can outweigh these
risks. Careful medication management by health care professionals can reduce
these risks. We are requiring this information to be added to the buprenorphine
and methadone drug labels along with detailed recommendations for
minimizing the use of medication-assisted treatment (MAT) drugs and
benzodiazepines together.”

Hydrocodone and acetaminophen (Vicodin).This schedule II drug is used for

the treatment of moderate to severe pain, largely after surgery. It earned a black
box warning due to its highly addictive potential, as well as the increased risk of
respiratory depression and significantly increased risk of liver damage/failure
associated with its use.
Sertraline hydrochloride (Zoloft).Indicated for the treatment of major
depressive disorder, OCD, PTSD, panic disorder, and social anxiety disorder, this
selective serotonin reuptake inhibitor antidepressant received a black box
warning due to the increased risk of suicide associated with its use in several
demographics, including children, adolescents, young adults.
Ticagrelor (Brilinta). This antiplatelet medication received FDA approval in
2011, and is indicated to reduce the risk of CV death, MI, and stroke in patients
with acute coronary syndrome or a history of MI. However, it secured its black
box warning for causing significant and sometimes fatal bleeding. Ticagrelor
should not be prescribed for patients with active pathological bleeding or a
history of intracranial hemorrhage, and should not be initiated in patients
undergoing urgent coronary artery bypass graft surgery. Also included in the
black box warning: Ticagrelor increases the risk of subsequent CV events upon
premature discontinuation; therefore, managing bleeding events without
treatment discontinuation is advised. Ticagrelor’s labeling also cautions that
maintenance doses of aspirin greater than 100 mg can reduce the efficacy of
ticagrelor and should thus be avoided.
Tigecycline (Tygacil). An injectable antibiotic, tigecycline is indicated for the
treatment of complicated skin structure infections, complicated intra-abdominal
infections, and community-acquired bacterial pneumonia in patients aged 18
years and older. However, the tetracycline class antibacterial carries a black box
warning for increasing all-cause mortality vs comparators. Thus, it should only
be used for infections that cannot be treated with other medicines.
As a provider, it’s your duty to report any drug-related adverse event you
observe or are informed about during patient visits. These reports help to alert
the FDA of side effects that may not be covered in a drug’s package insert,
important safety information, or medication guide, and can lead to the addition
of new boxed warnings. To report an event, you can submit an electronic form,
mail a report form to the agency, or call them directly (1-800-FDA-1088). Once
you report an event, you can monitor the status of your report, or ask for the
general information regarding adverse events associated with the therapeutic.

DA Black Box Warnings of 8 Very

Common Drugs: Read Your Labels
Post Modified:  Sep 26, 2020  · Published:  Mar 23, 2017  By  Jacqueline  13
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A black box warning is a consumer warnings with a black border

placed on labels calling out the product’s serious health risks—like
the one that appears on tobacco packaging. It is the most severe type
of warning by the Food and Drug Administration (FDA).
Black Box warnings are not something to take lightly. For the FDA
to warn about a drug means it’s pretty bad (the last stop before a
recall notice)! I believe the black box warnings are a result of the
many lawsuits that are being won by injured patients and demanding
them to warn others.

“To be forewarned is to be forearmed.” ~old proverb

Get your free copy of the Vital Vaccine Info E-Book
 
Here are just 8 of the common drugs in various categories:

1. Pradaxa (Blood Clots)

Patients who stop taking Pradaxa without continuing some
anticoagulation protocol increase the risk of stroke. In older patients,
there’s a significant trend toward internal bleeding. Its mechanism of
action involves blocking “thrombin” which causes blood to clot. See
more here: https://www.consumersafety.org/drugs/pradaxa/

Why a Black Box warning?

 After only the first two years on the market, the

anticoagulant drug Pradaxa had been linked to more than
500 deaths. That number is now in the thousands.
(source)

2. Adderall (ADHD)
Adderall is a stimulant, amphetamine drug used to treat ADHD, but
is also frequently used recreationally by college students and others
to lose weight, stay awake and study longer, recreationally to
get high. The risk of serious Adderall side effects typically
outweighs the potential benefits of the drug.

Why a Black Box warning?

 The FDA announced they have received 51 reports of

sudden death in children and adults who took Adderall.

 On college campuses nationwide, Adderall and other

ADHD medications are quickly becoming drugs of choice
as popular study aids. It seems caffeine just does not cut it
anymore for late night cram sessions. (Source)

 Increased risk of sudden death and cardiovascular events

(Source)
 
 (Source)

3. Black Box Warning for Xanax (Anxiety)

Xanax is a benzodiazepine drug. It’s also used to manage phobic
behaviors and specific conditions like social anxiety. Prescription
rates in the last 18 years have risen only 67%, but the number
of Xanax related deaths per year  has multiplied sixfold.

Why a Black Box warning?

 Taking Xanax along with opioid painkillers or cough

medicines containing opioids may cause can cause extreme
sleepiness, slowed breathing, coma, and death
  Highly addictive

 Minimum dosage is recommended and should be

monitored (Source)
And in 2015 alone, 9,000 deaths were due to a sham Xanax pill.

4. Cipro (Bacterial Infection)

Ciprofloxacin is in a class of antibiotics called “fluoroquinolones”
and includes Levaquin and Avelox used to treat bacterial infections
of all different types like chronic bronchitis, infectious diarrhea,
urinary tract infections (UTIs) and more.

Why a Black Box warning?

 Vastly increased risk of tendonitis and tendon

rupture (incl. Achilles tendon)

 Events of acute liver damage

 Common nervous system damage and neurotoxicity.

Reports found in over 300 studies (Source)
Amy’s story: Cipro, Levaquin, Avalox: Fluoroquinolone
Antibiotics That Will Ruin You!!

Black Box Warning for Avelox (see Cipro

above)
Have you suffered a tendon rupture or tendonitis while taking
Avelox? In the same class as Cipro and Levaquin. Avelox tendon
ruptures can be very severe, and lead to life-long disability.

5. Black Box Warning for Synthroid

(Levothyroxine) (for Hypothyroidism)
Synthroid (levothyroxine) is the number one brand-name drug in
terms of number of prescriptions written by physicians – over 23
million scrips/month. It is usually given for Hashimoto’s, an
autoimmune disease, and when thyroid cancer lowers the circulating
thyroxine in the body. But we also see subsequent development of
dementia of the Alzheimer type  with Thyroid medication use.

Why a Black Box warning?

  Consumers may be at increased risk for a variety of
ailments when taken for weight loss – often prescribed
but not effective for weight loss/obesity

 High doses may cause toxicity especially when used in

combo (see below)

Note for
alternative help: Desiccated thyroid is much better tolerated
than Levothyroxine by most, but doctors nowadays tend to be
afraid of it. Drug companies saw it as competition and gave it a bad
rap. It was standard practice before Synthroid was invented. There
are many brands of desiccated thyroid…NP
Thyroid, Armour, Naturethroid, etc. Desiccated thyroid has been
on the market and safely used for more than 100 years. Until
synthetic thyroxine (also known generically as levothyroxine, with
brand names including Synthroid, Levoxyl, and Tirosint) was
introduced in the 1950s, desiccated thyroid was the only thyroid
hormone replacement medication. My mom and MANY others did
very well on it all those years with no cognitive side effects.

Check out GetRealThyroid.com for NatureThroid!

Medicare will not pay for any Thyroid medication that is natural.
Will only pay for synthetics, SO check out GoodRX for NP
Thyroid, Armour, Naturethroid, etc.. One reader said, “I can get
my natural thyroid meds for less  than what I’d pay with my
insurance. If your doctor won’t let you use GoodRX because of
Medicare, go to another pharmacy and do not give them your
Medicare number.”

6. Vicodin (Pain relief)

Vicodin is a synthetic drug formed by combining acetaminophen (the
active ingredient in Tylenol) and hydrocodone, which is an
extremely powerful opioid. It’s commonly prescribed for pain
relief after surgery, and even after less serious surgery like
wisdom teeth removal.

Why a Black Box warning?

 Highly addictive

 According to data from 2011, opioid painkillers like

Vicodin caused more deaths than illicit drugs

 Increased risk of respiratory depression

 Risk of fatalities from accidental consumption (especially

in unaccompanied minors)

 Risk to baby if taken during pregnancy

 Significantly increased risk of liver damage/failure

7. Zoloft (Depression)
The FDA insists all generic drugs sold in the U.S. are “identical” to
their brand name counterparts. Many disagree. Controversy
surrounds generic sertraline (Zoloft). This antidepressant is taken by
millions of people. The reports make you wonder how good a job the
FDA is doing at monitoring foreign-made pharmaceuticals. (source)
Why a Black Box warning?

 Increased risk of suicide in children, adolescents, young

adults

 High risk of major depressive or other psychiatric disorders

(mania, hallucinations)

 Resulted in numerous Birth defect lawsuits  – do not take

when pregnant!
8 Million US Kids Taking Psychiatric Drugs:  Parents Not Told
the Deadly Documented Risks

8. Celebrex (NSAID) 
Prescription Celebrex should be used exactly as prescribed at the
lowest dose possible and for the shortest time needed. (Source)

Why a Black box Warning?

 potentially fatal cardiovascular thrombotic events, incl.

heart attack, heart failure and stroke

 risk may occur early in treatment and may increase with

duration of use

 high risk of life-threatening allergic reactions and kidney

problems
In addition, medical practitioners downplay the dangers of NSAIDs,
as do the pharmaceutical companies that make these popular OTC
drugs. Research reveals (pg. 309-310) that NSAIDs (and
CELEBREX) have been shown to:
  Accelerate the progression of osteoarthritis

 Increase risk of joint replacement

 Inhibit the cells that form cartilage

 Inhibit collagen synthesis

 Inhibit substances that act as a lubricant and shock

absorber
 

The Black Box Warning – the unknown,

unconsented agreement

Whether you knew it or not – by opening a black box

labeled bottle or package you have accepted that these
black-box warnings of serious and fatal side effects can
occur. Proceed at your own risk or that of your loved
one.
Get your free copy of the Vital Vaccine Info E-Book
 

Sadly, it’s very unlikely most patients will read a black box warning.
Most patients rely on their doctor or pharmacist for advice; so an
increased warning on a drug’s label may in reality make little
difference.
Research For Yourself:
 Use the FDA Access Data site to research the drugs you
currently take.

 Use the Pubmed resource to search through clinical trials.

 Search ConsumerSafety.org
Never stop taking a medication without speaking with your doctor
first.
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Hi! I'm Jacqueline!

Thanks for being part of this journey with me.

Welcome to my own little place on the internet! Home is where I love to be. I feel there is
no greater place to incubate souls. These days you’ll find me using my experiences here to
write about herbal remedies and natural health research — a big passion of mine. But being
a wife and mother is not easy. It is challenging and potentially lonely. I get that. I wanted to
create a place to connect with and support other moms for creating a natural, healthy, and
fulfilling home life.