8 FDA Black Box Warnings Of Very Common Drugs: You May Regret Not Knowing

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

8 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​ ​other​s 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) ​​

3. 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 Avalox 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!!

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. 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 thyroxin 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)

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 absorbe

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.

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​ ​trial​s.​
• Search ConsumerSafety.org

Never stop taking a medication without speaking with your doctor first.

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