FDA Black Box Warnings of 8 Very Common Drugs: Read Your Labels

A black box warning is a consumer warning 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 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)! 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

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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?

• Within the first year after release, 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. 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 six-fold.

Why a 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. Xanax is designed to be used for very short periods of time, like a day or a few days at a time. (source)

• Minimum dosage is recommended and should be monitored (Source)

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

We need to get over the impulse to take a drug—when counseling and getting off of social media (which drives anxiety) would be better long term choices.

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. blown Achilles tendons)

• Events of acute liver damage

• Common nervous system damage and neurotoxicity. Reports found in over 300 studies (Source)

See 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? It is 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.

“The probable role of thyroid hormones (like levothyroxine) in Alzheimer’s Dementia pathology has already been established, primarily in the area of beta amyloid plaque accumulation.” ~PubMed study

Why a Black Box warning?

• Doctors often prescribe Levothyroxine (Synthroid) for weight loss/obesity, but it is NOT effective for weight loss or obesity. Taking Levothyroxine (Synthroid) for a reason it doesn’t even address, INCREASES your risk for Dementia.

• Higher doses cause toxicity especially when used in combo with other weight loss aids (see warning in image 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 the safe 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!

READ: 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.

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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Medical Disclaimer: I am no longer a practicing medical professional, and I am not doctor. I am a mother. I do seek scientific confirmation of the safety and effectiveness of the herbs and remedies I use. Using remedies is a personal decision. Nothing I say on this blog is intended to treat or prevent disease. Consult your own doctor.

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