Is the FDA’s Definition of Safe a Lie?

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.