The People's Perspective on Medicine

Is the FDA’s Definition of Safe a Lie?

Words matter! That's why we are outraged at the FDA's definition of "safe." The agency claims that all drugs it approves are safe, but some harm people.
FDA Approved words on an orange pill or medicine bottle with long shadow

The Food and Drug Administration insists that its focus is on making sure all drugs are “safe and effective. For example, this headline from the FDA’s website says it all:  “The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective.” There’s no hedging or fudging. There is also this description of the FDA’s approval process:  “Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER [Center for Drug Evaluation and Research] the evidence from these tests to prove the drug is safe and effective for its intended use.” So, a drug company must “prove” its medicine is “safe” before it can be sold. What the FDA does not do is tell patients or health professionals what its definition of safe actually is.

What is the Definition of Safe?

If the foundation upon which the FDA approves all medicines is that they must be proven “safe and effective,” what does that mean? Most people have an idea of the word safe. It might even seem simple. In the Alice-in-Wonderland world of the Food and Drug Administration, what may seem simple is incredibly complex.

The Merriam-Webster dictionary definition of safe goes like this:

“1: free from harm or risk: UNHURT

2: secure from threat of danger, harm, or loss

3: affording safety or security from danger, risk, or difficulty

5: not threatening danger: HARMLESS”

The FDA’s Definition of Safe:

When we asked a representative of the FDA how the agency defines safe, we were told that

“believe it or not our Food and Drugs Act of 1906 founding fathers were specifically unspecific describing ‘safe and effective’ as it applies to drugs.”

Don’t you love it?

“Specifically unspecific”

Alice in Wonderland:

This reminds us a lot of a passage from Lewis Carroll’s Through the Looking-Glass. It goes like this:

 “When I use a word,” Humpty Dumpty said, in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.”
“The question is,” said Alice, “whether you can make words mean so many different things.”

What is Your Definition of Safe?

If the average person takes “safe” to mean what Merriam-Webster defines as “free from harm or risk,” or “secure from threat or danger,” then the FDA has been misleading us for decades. All one has to do is watch a prescription drug commercial on television to realize that most of the drugs being advertised do not come close to satisfying Merriam-Webster’s definition of safe.

Is Chantix “Safe”?

The “Slow Turkey” Commercial

Take the highly promoted stop-smoking drug varenicline (Chantix). As you watch an animated turkey  emerge from a tent in the woods the announcer says “It’s tough to quit smoking cold turkey so Chantix can help you quit slow turkey.”

Eventually you get to the warning section:

“Stop Chantix and get help right away if you have changes in behavior or thinking, aggression, hostility, depressed mood, suicidal thoughts or actions, seizures, new or worse heart or blood vessel problems, sleep walking or life-threatening allergic and skin reactions.”

After hearing that list of potential side effects most people would conclude that Chantix is not “harmless.”

Is Abilify Safe?

A commercial for the antipsychotic drug aripiprazole (Abilify) promotes this medication for hard-to-treat depression.  The warning states:

“Elderly dementia patients taking Abilify have an increased risk of death or stroke.

Then we get to the hard-core side effect announcement:

“Call your doctor if you have high fever, stiff muscles and confusion to address a possible life-threatening condition or if you have uncontrollable muscle movements, as these can become permanent. High blood sugar has been reported with Abilify and medicines like it and in extreme cases can lead to coma or death. Other risks include increased cholesterol, weight gain, decreases in white blood cells which can be serious, dizziness on standing, seizures, trouble swallowing, and impaired judgement or motor skills.”

In your opinion does this medication fit the dictionary definition: “secure from threat of danger, harm, or loss”? We didn’t think so.

We could go on and on about TV commercials that list heart attacks, strokes, kidney failure, hemorrhage, cancer or death as possible side effects. Does any of this fit a definition of safe?

Stories from Readers:

Joan’s husband died after taking amiodarone:

“My healthy husband went for a physical because he was going to retire. The doctor diagnosed him with Afib. He prescribed amiodarone for this condition.

Within five weeks, my husband could not function and went in for cardioverson to fix the Afib. The doctors at the hospital said he was not getting enough oxygen. He went into the ICU for three weeks and was diagnosed with lung poisoning from that drug. He got worse each day and then my beloved husband died.”

 Brian’s father also suffered lung toxicity from amiodarone:

 “My father was given amiodarone just after he had ablation surgery. He was on blood thinners from a stent they had put in a few months prior for a 90% blockage. He’s 74 years old, and other than the Afib he was very active.

“His cardiologist put him on this drug without telling him about the side effects or following up to monitor his reaction. He complained of severe fatigue, blood in his stools and shortness of breath. The doctor said it was the Afib and suggested  he needed a second ablation.

“Two weeks later my dad couldn’t breathe and could barely move. In the ER they found he now had pulmonary fibrosis from amiodarone toxicity. He spent two weeks in intensive care. He is now in rehab on high flow 100% oxygen. He went from active to bed-ridden in weeks due to this drug.”

 Learn more about amiodarone toxicity at this link.

 Michael’s father died because of a fluoroquinolone antibiotic reaction:

“My father was a healthy, 75-year-old man who didn’t smoke or drink. He died in surgery from aortic aneurysm and dissection. They  surgeons took five hours for what was they said, ‘The worst case in Oregon they had ever seen!’ The surgeon stated, “The aorta was so flimsy it just kept tearing and fell apart. The walls of the aorta were so thin, there was nothing we could do.’

“My Dad bled to death on the operating table Dec. 18, 2018, two days before the FDA released its warning about fluoroquinolones and aortic aneurysms and dissection. He’d had a respiratory infection, so the doctor prescribed an antibiotic. But Dad was walking the dog every day, going to the gym twice a week and had lost 30 pounds recently. He directed his church choir, played tuba in a brass band, and was starting a barbershop quartet. He was so full of life, with a strong voice and spirit.

“I did not get a chance to talk to my Dad that day at the hospital. He was lucid and doing fine and waited for over two hours to find a doctor who could do the surgery. Although the surgery was risky, Dad was strong. As a result, the doctor and surgical team could not believe how flimsy the aorta was when they opened him up and started the procedure.”

Here is more information about this extremely serious side effect.

 

Kathy almost died from a Clostridium difficile infection brought on by clindamycin:

“I contracted C. diff after a dental procedure and antibiotic prescription. After one week I was extremely ill. I called the dentist and he said “just keep taking it.” I did not , but the damage was already done. It was so severe that I ended up in the ER and was hospitalized for three days. My colon had started to rupture and I was bleeding out of my rectum. My internist said I would have died within a short time. Yes, it was the clindamycin.”

 FDA, Please Tell the Truth! Drugs are Dangerous

Perhaps it is time for the FDA to admit that it routinely approves drugs that are not safe. It can no longer fall back on the idea that its founding fathers were “specifically unspecific” when referring to the definition of safe. Why not just admit that it routinely approves drugs that are dangerous?

Merriam-Webster defines dangerous as:

“1: involving possible injury, pain, harm or loss

2: able or likely to inflict injury or harm.”

What Do You think?

What is your definition of safe? Share your thoughts about FDA’s insistence that it only approves medications that have been proven safe and effective. By the way, the word effective is a whole other matter we shall reserve for another day. Most people assume their medicine will work. In truth, the FDA routinely approves drugs that are barely better than placebo. In other words, scores of patients may have to take a medicine for one to actually achieve a measurable benefit. Here is an article we have written about statins and older people. It illustrates this point about effectiveness.

We welcome your thoughts in the comment section. You may also find our book, Top Screwups Doctors Make and How to Avoid Them, of great help in preventing dangerous or deadly drug reactions.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Regardless of how the FDA defines “safe”, there are NO 100% SAFE medications. The FDA is responsible for using information provided to them to determine whether a drug is safely usable to treat a condition, by most people. They have no control – until there are problems – over misprescribing & misinforming by doctors, or misleading advertising. FDA can not force patients to read the labels, the drug info inside the package or the printed information handed to the patient by some doctors. This is true for prescription medication, OTC medications & supplements.

As with so much in our healthcare system, money and politics are the main motivators. The FDA is run by politicians and is dependent on drug company fees for much of its funding. We should not be surprised that the agency would not bite the hands that feed it.

Thank you for this article! In particular, thank you for continuing to highlight fluoroquinolone issues, as they are one of the most prescribed antibiotic families and can have serious and deadly effects. I am one of the many people disabled by these drugs, without any warning from my doctors or any understanding of their potential long term or permanent impacts. I will never take another drug without reading the info, not that that will prevent every adverse reaction but at least I know not to assume drugs approved by the FDA are safe.

12 years ago I received IV Levaquin as a prophylactic during minor surgery. I was not informed about the insidious delayed reactions. The doc could have selected a safer drug. I had no infection. I am permanently disabled!

I recently received a voicemail from my doctor telling me to pick up a bisphosphonate at the pharmacy. This was after zero discussion, zero mention of possible concerns. Did my own research and decided on a different approach to osteoporosis. I personally consider it malpractice to fail to discuss side effects. The FDA goes a step further, essentially telling us we don’t need to research or believe what we read. We must be our own advocates always and stick to our values,not adopt theirs.

TERRIFYING!!! I have been afraid of pharmaceuticals for years. This makes me more afraid. My doctor has been trying to get me to take osteoporosis drugs for years, and I refuse. He also used to try to get me to take statins,which I also refused. He has given up on the statins. I’m not sure if it is because I consistently refuse or because he has become more knowledgeable about cholesterol. My total cholesterol reading is consistently above 200, as high as 220, but my HDL is above 100.

I would love it if you would address natural ways of fighting osteoporosis and when we should really be worried.
Thank you!!!

It seems abundantly clear, and has for a very long time, that the FDA is far more concerned with facilitating for big pharma than protecting the american people.

It is way past time for people to be proactive and willing to make changes in lifestyle. The brain washing is continual, often subtle, and all pervasive. Working on the veterinary side for 20 plus years I can attest to the success of pharmaceutical companies.

I often heard ” Isn’t there just a pill I can give them?”, when behavior and/or lifestyle changes were recommended. The public has been trained for years that “better living thru chemistry” is possible, safe and effective. I have believed for a very long time that it is, has been, and will continue to be ALL ABOUT THE MONEY!!!

First, about that “call your doctor” direction if one experiences a dire side effects symptom: Has anyone tried to call a doctor recently? One could be long dead before connecting with a physician. The warning should direct one to the nearest ER or urgent care center. Second, many drug companies and researchers have proven themselves fraudulent by not reporting negative effects found in testing. What I do: tell my health care provider to prescribe only tried-and-true medications unless only a new wonder drug is available to treat my health problem. “Safe” is an abstract concept that has no place in health care.

These days, the cure is more likely worse than the disease. I no longer fill any new prescriptions until I research the side effects first. And I have refused to take one medication because of the side effect risk.

Words are powerful indeed! I think we should all wake up and realize that the FDA does not approve drugs. The FDA approves the formulation of medications. Just because I, more or less, follow a recipe doesn’t guarantee that my cookies will taste good.

The FDA is worthless in my opinion. I complained to them about a generic drug that did not work and wrote to the FDA as instructed. I received a reply that was ridiculous and did not make any sense. The FDA is more for big Pharma than the American people. I have Rheumatoid Arthritis and refuse to take any big pharma drugs due to the terrible side effects and what they do to your body. I try to live a healthy life by eating whole foods and taking supplements like tumeric and medical cannabis, which have been a life saver for me.

I am 66 years old and am on no drugs. I was on lisinopril for 25 years and convinced I didn’t need it. For the past year my average daily BP is 119/75. I always complained about the lack of skill when having blood pressure taken in the office. They always do it wrong. And, for me that led to lisinopril.

When I presented my long-term BP findings to my doctor he said your BP is high over the last 3 visits. Funny isn’t it when you visit the doctor it’s because you’re sick which can raise BP and they always take it incorrectly. When faced with my data vs. his he said ” Here are the facts” I no longer go to him for care.

I am not anti-drug I am anti stupid. Do your homework, know your options and remember that you are responsible for how you are treated and what you take. Your liver will thank you.

It is a bit frustrating though when most people talk to me about meds and I give my point of view I can see they are thinking this guy is out there. All people want is the pill and they are sold a bill of goods each time. The doctor always says everything has some type of downside but the upside is good. So the patient dutifully takes the med.

Reading this article makes my blood pressure go up!!! In 2003, at age 56, I began to have atrial flutter. I was a non-smoking, non-recreation-drug using, tea-totaling health nut; I still am. I did have asthma, apparently triggered by pollen. My doctor had given me Advair and albuterol, three months before the flutter began, for the asthma. Of course, when my doctor discovered the flutter he sent me to the emergency room. They gave me some anti arrhythmic drug. I can’t remember the name. The drug kicked my heart into atrial fibrillation. Then they gave me a drug to stop my heart to reset the rhythm. It worked temporarily. I told them I was taking Advair and albuterol but they said nothing about that being a potential cause for the arrhythmia.

So, what was atrial flutter was now serious atrial fibrillation that required emergency room visits at least 12 times in the following 18 months for cardio conversions. No one said anything about the Advair and albuterol. My cardiologist said I needed an ablation. I dutifully followed the doctor’s orders and arrived for my ablation, which I was told would take a couple of hours and completely solve the problem. Ten hours later I coded, and they were unable to resuscitate me. As the electrophysiologist was telling my wife I didn’t make it the nurse came into the waiting room and informed the doctor that my heart had started again. When I finally awoke I had a pacemaker stuck in my neck. And I still had an arrhythmia.

My cardiologist sent me for a 2nd ablation with a different electrophysiologist six months later. After a six-hour ablation this time this doctor said that the first doctor was trying to ablate a “phantom arrhythmia” that didn’t originate in my heart. I was still taking Advair and albuterol for asthma. It was in my medical records, and every doctor knew it. They added amiodarone, so I now had a three-prescription daily regimen, and I started to have serious vision problems.

After the 2nd failed ablation I went to an old integrative medicine doctor in Washington, D.C. and told him the story I just related. He laughed out loud, which really ticked me off. He went into the back room and came back with a glass of milky white water and told me to drink it. Twenty minutes later my arrhythmia stopped! Rather than being grateful I was really mad. An ignorant electrophysiologist had fried my atrioventricular node during a botched ablation, and I now have a complete heart block and a pacemaker. All it took to stop the atrial fibrillation was 5 grams of arginine and 15 grams of taurine.

The old D.C. doc also told me to go off the Advair and albuterol and stop taking the frickin’ amiodarone, his words, not mine. Now I take 5 grams of arginine and 15 grams of taurine every day, and I haven’t had an arrhythmia since. I wouldn’t go to a cardiologist except that I still have a complete heart block and a pacemaker. My pacemaker had a catastrophic failure in 2015, and I had to be rushed to the hospital to have it replaced.

If anyone knows a solution for a fried A/V node please let me know.

I think it’s past time we stop allowing Big Pharma to line Politicians pockets with money. They need to be kept honest. The fact that they can put out a new drug to experiment on what it actually works best for, and then re-market this drug on their findings, change the name of the drug when and after it’s caused harm/death, and then prescribe this same drug for a different condition. This is not my definition of SAFE.

I am always telling people that they need to research any drug to learn the side effects and risks before taking it. Do not just automatically take it assuming the Doctor would inform you of the side effects because they don’t!!! They either haven’t got a clue what the side effects are or they know but neglect to inform you. It’s your body and your life and the Doctor and Big Pharma really don’t care. Have you ever gone to a Doctor and left there realizing that you know more than the Doctor? Happens to me a lot and that angers me.🤬🤬🤬

I figured out years ago that I have to advocate for myself. Any time I’m given a drug I research it first before taking it. To this day I have doctors who seem put out when I start asking too many questions. They seem to want you to take what they recommend, no questions asked. It took me a long time to find a doctor open to discussion. I’m not anti-prescription drug, but there are many natural remedies that can be used as a first line of defense. What has happened in the world of pharmaceuticals and the influence they have on doctors is disheartening.

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