Why don’t Americans care more about adverse drug reactions? Perhaps we assume that bad things only happen to other people. Or perhaps dangerous drug side effects have become so familiar that we no longer hear the warnings. Our love affair with pharmaceuticals suggests that many people take an optimistic view of the medicines they see advertised on television. The actors look happy. The music is cheerful. People dance, hike, travel, play with dogs and children and enjoy romantic dinners.
Meanwhile, an announcer races through a frightening list of possible complications. It’s easy to ignore nasty-sounding drug complications when the people in the commercials are having so much fun.
When Dangerous Drug Side Effects Become Background Noise
Watch almost any television commercial for a prescription medicine and you may be overwhelmed by the warnings. Take Jardiance (empagliflozin), for example. This medicine was initially promoted primarily for people with type 2 diabetes. It is now also prescribed to reduce certain cardiovascular risks and to treat heart failure and chronic kidney disease.
One 2023 television commercial described Jardiance as “a little pill with a big story to tell.”
While actors danced through the commercial, the announcer warned:
“Jardiance may cause serious side effects including ketoacidosis that may be fatal, dehydration that can lead to sudden worsening of kidney function and genital yeast or urinary tract infections. A rare life-threatening bacterial infection in the skin of the perineum could occur.”
More recent commercials have featured singing, dancing, acting and even world-class sprinter Usain Bolt knitting.
While viewers watch all that cheerful activity, they hear about some pretty worrisome warnings:
“Serious side effects include increased ketones in blood or urine and infection between and around the anus and genitals, both may be fatal, severe allergic reactions, dehydration, urinary tract or genital yeast infections in men and women and low blood sugar. Stop taking and tell your doctor right away if you have nausea, vomiting, stomach pain, tiredness, rash, swelling, trouble breathing or swallowing.
“Tell your doctor about lightheadedness, weakness, fever, pain, tenderness, redness, or swelling between the anus and genitals. You may have increased risk for lower limb loss. Call your doctor right away if you have new pain or tenderness, sores, ulcers or infections in your legs or feet.”
I don’t know about you, but warnings about limb amputation and tenderness, redness, or swelling between the anus and genitals sounds nasty to me.
You might think warnings like these would terrify viewers. Instead, the upbeat images and rapid delivery may turn the risks into little more than background noise.
How many people truly absorb a warning about a potentially fatal infection while watching a celebrity sprinter knit? Here, see for yourself below:
Then there is the singing and dancing commercial that you have probably seen a few times. Watch as the mailman starts dancing!
Why Do People Tune Out Drug Warnings?
Drug companies are required to disclose important risks in prescription drug advertising. The FDA expects advertisements to present a fair balance between benefits and harms.
But satisfying a disclosure requirement is not necessarily the same as communicating effectively. You might imagine that listening to a long list of dangerous drug side effects could discourage some people. Millions of people still take Jardiance, despite the warnings you have read above.
The Problem with Long Lists of Dangerous Drug Sides Effects
The warnings are often:
- Delivered rapidly
- Packed with unfamiliar medical terminology
- Presented without meaningful numbers
- Accompanied by soothing or upbeat music and pleasant images
- Mixed together in a long list of problems ranging from annoying to life-threatening
By the time the announcer reaches the end, many viewers may have stopped listening or felt overwhelmed.
Words such as rare, serious and life-threatening sound important. But without numbers, they provide little help to someone trying to make a decision. Does “rare” mean one person in 100? One in 1,000? One in 100,000?
Does “common” mean five people out of 100 or 50?
People are being warned, but they are not necessarily being informed.
“There Is No Such Thing as a Safe Drug”
When we published the first People’s Pharmacy book in 1976, we could not have imagined that prescription drug commercials would someday fill American television screens.
We did warn readers, however:
“There is no such thing as a safe drug…Successful treatment is a careful balance between the beneficial and harmful effects, hopefully weighted in favor of the beneficial.”
That statement upset some physicians and pharmacists at the time. Many health professionals thought patients should not be told too much about medication risks. They worried that people might become frightened and refuse useful treatment.
We never advised people to reject medicines that could improve or save their lives. Our point was that every medicine poses a tradeoff. People deserve accurate information in ways they can understand.
We have repeatedly harped on metrics such as the number needed to treat (NNT). That is a way of calculating how many people would have to take a particular medicine for one person to get a meaningful benefit. Has your healthcare provider ever provided you with the NNT for a medicine you are taking?
Another crucial number is the absolute risk reduction (ARR). If someone who has never had a heart attack were to take a statin to lower “bad” LDL cholesterol for 5 years, how much would the drug diminish the risk for a heart attack? In the case of atorvastatin it is 1%. In other words, 1 person out of 100. That stat comes from the drug company itself.
If you would like to learn more about where that number came from, here is a link to an article I wrote titled:
Drug Effectiveness: The Missing Number Behind Every Prescription
Has a health professional ever described drug effectiveness in a way you could understand? Discover how to learn the true benefits of meds.
A drug may be extremely valuable for one person and inappropriate for another. The potential benefit should be large enough to justify the possibility of harm. Patients cannot make that judgment unless they receive understandable information about both sides of the equation.
The Human Toll of Adverse Drug Events
Medication-related harm is not a minor public health problem.
The Centers for Disease Control and Prevention estimate that:
- More than 1.5 million people visit emergency departments for ADEs [adverse drug events] each year in the United States, and almost 500,000 require hospitalization.
Older adults are especially vulnerable. According to the CDC, people 65 and older make more than 600,000 emergency department visits annually because of adverse drug events.
The American Society of Pharmacovigilance (ASP) has estimated that adverse drug events may contribute to more than 250,000 deaths annually. If that estimate is accurate, medication-related harm would rank among the country’s leading causes of death.
Here is how the ASP describes the significance of its estimate of adverse drug events (ADEs):
“This number would place ADEs squarely behind only heart disease (~695,000 deaths) and cancer (~605,000 deaths) in the most recent CDC rankings of leading causes of death. It would mean ADEs outrank well-recognized conditions like stroke, diabetes, and Alzheimer’s disease. And yet, because ADEs are not coded as a unified cause of death—and are often classified under broader categories like “unintentional injuries” or hidden under the name of the resulting condition—their impact remains largely invisible in public health data.”
Our own calculations for the book Top Screwups Doctors Make and How to Avoid Them came closer to 400,000 deaths. Such estimates are inevitably controversial because death certificates rarely identify a medicine as a contributing factor.
The Indirect Nature of Dangerous Drug Side Effects
A fatal fall may be attributed to a broken hip rather than the sedative that caused dizziness. A deadly heart rhythm disturbance may not be traced to a drug interaction. Kidney failure, internal bleeding or an overwhelming infection may appear on the death certificate without any mention of the medicine that helped trigger it.
That makes the true toll extremely difficult to calculate.
Despite the enormous number of emergency visits and hospitalizations, drug complications do not appear on the CDC’s familiar list of the 10 leading causes of death. Nor is there a National Institute of Medication Safety devoted to investigating and preventing such harm.
Being Warned Is Not the Same as Being Informed
A physician or pharmacist may tell patients that a blood pressure medicine could make them dizzy when they stand up. But are patients told how likely that is?
Is it one person out of 100—or 10?
Someone starting a statin may be warned about muscle pain. A person prescribed a GLP-1 drug such as Ozempic or Wegovy may hear about nausea, vomiting or diarrhea. Someone taking lisinopril may be told that it could cause a cough.
The crucial question is rarely answered:
How likely is this to happen to me?
Even when percentages are available, they may be confusing.
Semaglutide, for example, is sold under several brand names and in different doses and formulations. Although the products contain the same basic compound, reported rates of nausea and diarrhea vary substantially among clinical trials of Ozempic, Rybelsus and Wegovy. And Wegovy comes in a pill form as well as in an self-injectable tube.
That does not necessarily mean the numbers are wrong. Different doses, patients, study designs and treatment goals can produce different results.
But it leaves patients with a puzzle. Which number applies to them?
Clinical Trials Cannot Reveal Everything
The official prescribing information for a drug usually contains a section describing adverse reactions detected during clinical trials. The National Library of Medicine makes current drug labels available through its DailyMed website.
These data can be useful, but they have limitations.
Clinical trials often:
- Last for weeks or few months rather than years
- Exclude people with multiple health problems
- Enroll patients taking fewer medicines than many real-world patients
- Focus on a predefined list of adverse reactions
- Include too few people to detect unusual or delayed complications
A problem affecting one person in 10,000 would probably not show up in a trial involving a few thousand participants.
Delayed side effects present another challenge. If a reaction develops after several years, a short clinical trial has little chance of detecting it. That is one reason patient experiences are so important.
When Side Effects Show Up Years Later
Both patients and health professionals often assume that if someone has taken a medicine for years without difficulty, a new symptom could not possibly be related to the drug.
That assumption can be wrong.
We have heard from people who developed a persistent cough after taking the blood pressure drug lisinopril for months or years. Others experienced angioedema—dangerous swelling of the lips, tongue, throat or intestines—after taking an ACE inhibitor for years without an obvious problem. But angioedema can be a life-threatening drug side effect.
Patients taking metformin may develop severe or persistent diarrhea long after starting treatment. Because the drug was well tolerated initially, neither the patient nor the prescriber may recognize the connection.
When an adverse reaction appears gradually, it can be blamed on aging, stress or a new disease. The patient may be referred from one specialist to another while the medicine responsible remains on the medication list.
What Does “Rare” Mean in the Real World?
Clinical trials are not the only source of drug-safety information. After a medication reaches the market, millions of people may take it under conditions far different from those in the original research.
Patients may be older, frailer or taking several other drugs. They may have kidney disease, liver problems or genetic differences that alter the way their bodies process medication.
Doctors, pharmacists and patients can report suspected adverse reactions to the FDA via MedWatch. These reports sometimes identify previously unrecognized problems. But this system also has limitations. Most adverse reactions are never reported. When they are submitted, the reports cannot always establish that the medicine caused the problem.
We had an ongoing “relationship” with one of the FDA’s highest executives. He tended to discount side effects that were “only” reported by patients to the FDA’s MedWatch system. He preferred the randomized controlled trials carried out by the pharmaceutical industry.
That creates an uncomfortable gap between controlled research and real-world experience. Drug companies and regulators may say there is not enough evidence to prove a connection. Patients may respond that they experienced a dramatic problem that disappeared when the medicine was stopped and returned when it was restarted.
Both clinical data and lived experience matter. Neither should automatically cancel out the other.
How to Learn About Dangerous Drug Side Effects
Consumers should not have to become pharmacologists to use medicine safely. Nevertheless, patients and their families often need to do some homework.
DailyMed is a good place to begin. Search for the drug and look for the section labeled “Adverse Reactions.” The medication guide written for patients may also describe symptoms that require immediate attention.
Do not be surprised if the information is dense or difficult to interpret. Package inserts are written partly to satisfy regulatory and legal requirements. They are not always designed for easy reading by patients.
Always ask your prescriber or pharmacist:
- If 100 people take this medicine, how many are likely to benefit?
- How many are likely to experience the most common side effects?
- Which reactions are dangerous rather than merely unpleasant?
- Could any problems appear only after months or years?
- Do my other medicines interact or increase the risk?
- Which symptoms mean I should call immediately or go to the ER?
- Is there a safer alternative that offers a similar benefit?
A healthcare professional may not have an immediate answer to every question. That is understandable. But “I don’t know; let me look it up” is far more useful than a vague assurance that a reaction is rare. You deserve actual numbers such as the NNT or the ARR (absolute risk reduction).
Do Not Stop Important Medicine Suddenly
Learning about adverse reactions does not mean that people should abruptly discontinue their prescriptions.
Some medicines can cause serious withdrawal symptoms or a rapid return of the condition being treated. Suddenly stopping a beta blocker, anti-seizure medicine, corticosteroid, acid blocker, benzodiazepine or certain antidepressants can be dangerous.
Anyone concerned about a possible reaction should contact the prescriber and ask how to proceed safely. When a severe allergic reaction, breathing difficulty, swelling of the tongue or throat, fainting or another medical emergency occurs, prompt emergency care is essential.
The goal is not to frighten people away from medicine. It is to recognize problems early enough to prevent avoidable harm.
The People’s Pharmacy Bottom Line
For more than 50 years, we have tried to provide the candid story about the benefits and drawbacks of medicines. Sometimes a drug works wonderfully or saves a life. We are delighted to tell that story.
But no medicine is completely free of risk. Even commonly prescribed medications can sometimes cause serious problems. We have written about some of them in these articles:
- Abilify Side Effects Can Be Scary!
- Amlodipine (Norvasc) Side Effects Include Swollen Gums
- Atorvastatin (Lipitor) Side Effects & Complications
- Hydrochlorothiazide (HCTZ) Side Effects, Diabetes and Gout!
- Ibuprofen and High Blood Pressure: A Dangerous Reaction!
- Lisinopril Side Effects Can Be Life Threatening: Beware Angioedema and ACE Inhibitors!
- Pain Is Personal: Unexpected Gabapentin & Tramadol Side Effects
Television commercials may technically warn viewers about dangerous drug side effects, but a rapid list recited over cheerful music is not a substitute for meaningful information.
Patients deserve more than vague words such as rare or common. They need actual numbers whenever possible. They should know which symptoms are merely annoying, which may become dangerous and which require immediate medical attention.
Please do not wait until a life-threatening reaction occurs to learn about a medicine’s potential hazards.
And please do not allow anyone to dismiss a new symptom simply because it does not appear near the top of a computerized list. Your experience may be the clue that prevents a more serious complication.
Share Your Story
Have you ever experienced a drug side effect that your prescriber did not mention, or did not recognize?
Did a reaction appear only after you had taken the medicine for weeks, months or even years? Were you told that your symptom could not possibly be caused by the drug?
Please share your experience in the comment section below. Your story could alert another reader to a problem before it becomes an emergency.
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