When doctors prescribe a medication, the benefits are supposed to outweigh the risks. Do you remember the phrase “first, do no harm”? Doctors are expected to help people, not harm them. Unfortunately, it is almost impossible to predict who will experience bad drug side effects in advance. Medicine is still mostly a watch and wait game. Not infrequently, adverse drug reactions cause disability and death.
How Bad Are Bad Drug Side Effects?
If a medication triggers a complication serious enough to warrant a trip to a doctor’s office or an emergency department, it’s probably pretty bad.
According to Dr. Timothy O’Shea (Pharmacy Times, Feb. 2, 2016):
“Each year, an estimated 4.5 million Americans visit a physician’s office or emergency room because of side effects related to their prescription medications.”
According to the Food and Drug Administration:
• “There are 100,000 DEATHS yearly [from adverse drug reactions also known as ADRs]
• ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths”
And those bad drug side effects are associated with hospitalizations. The FDA admits it has no idea how many ADRs occur at home.
In its own words:
• “Ambulatory patients ADR rate—unknown”
We suspect adverse drug events (ADEs) at home are way more common than those that occur in hospitals. And the FDA relies on very old data for these estimates. We are afraid the current ADR rate is much higher.
The FDA’s Flawed Adverse Event Reporting System:
QuarterWatch is an independent watchdog publication that:
“monitors adverse drug events reported to the US Food and Drug Administration (FDA) by manufacturers, health professionals, and the public.”
In the December 4, 2019 QuarterWatch Report the analysis reveals:
“Given that reporting an adverse drug event to the FDA is voluntary for consumers and medical professionals, do the reports at least approximate the number of serious injuries and deaths that actually occur from therapeutic use of drugs? Do they accurately measure the types of injuries occurring most frequently, and reliably point to the highest-risk drugs? Are there better data sources to guide the important task of reducing injuries from drug treatment? Unfortunately, the answer to all these questions is: No.”
The number cruncher at QuarterWatch went on to note:
“On an annual basis the FDA receives more than 400,000 domestic reports of serious injury and death. If only 1 in 10 of these injuries resulted in a voluntary report, that would imply that as many as 4 million people experienced a serious or fatal injury that was suspected of being connected with their drug treatment. Could this conceivably be true?”
It is likely that only 1 out of 100 bad drug side effects is reported to the FDA.
Here is the analysis from QuarterWatch:
“We found that overall, only about 1% of the serious adverse events we studied had been reported, but with wide variation ranging from 7.6% of cases of one serious infection to less than 1 in 1,000 for severe gastrointestinal harms from [a] drug taken by 5.7 million people.”
The QuarterWatch report said not enough information was known to estimate how many persons experience adverse drug reactions, but added that the number of serious injuries “should be measured in millions.”
How Do You Learn About Bad Drug Side Effects?
What do you know about the side effects of the medications you are taking? If you see ads on television, you may think you are well informed. After all, any commercial that features a specific drug contains a long list of potential adverse reactions. How could you possibly need to know any more?
That long list of bad drug side effects might not be that helpful. Think about a trip to the grocery store. If you’re trying to buy more than ten items, you might need a written list so you don’t forget something important. Once you’ve heard seven or eight rapid-fire side effects mentioned on a TV commercial, they begin to blur together.
Then there are the visual distractions that the ad offers while the possible negative reactions are quickly read off. Usually, people are having fun, smiling or interacting with dogs or cute little kids. Pictures trump words, especially if the words are kind of technical.
There’s even an animated turkey doing human-like things in a stop-smoking commercial for Chantix. Talk about distracting visual images!
Do You Understand Bad Drug Side Effects?
We do not understand why the FDA allows pharmaceutical companies to use jargon or medical terms in TV commercials. Here is an example.
Jardiance for Type 2 Diabetes:
“Jardiance can cause serious side effects including dehydration, genital yeast or urinary tract infections and sudden kidney problems. Ketoacidosis is a serious side effect that may be fatal. A rare but life-threatening bacterial skin infection in the skin of the perineum could occur. Stop taking Jardiance and call your doctor right away if you have symptoms of this bacterial infection, ketoacidosis or an allergic reaction. Do not take Jardiance if you are on dialysis or have severe kidney problems. Taking Jardiance with a sulfonylurea or insulin may cause low blood sugar.”
What’s Wrong with this Commercial?
First, most people do not know what ketoacidosis is. That’s a big medical word. The viewer is told to stop Jardiance if symptoms of ketoacidosis occur, but nowhere in the commercial are you told what those symptoms are.
You are also told about a “rare but life-threatening bacterial skin infection in the skin of the perineum.” Many people do not know where the perineum is (another medical term) or what that potentially life-threatening skin infection might look like. We understand why the drug company might not want to be too specific in its commercial. The perineum in a man is roughly between the anus and the penis. In a woman it is the area between the anus and the vagina. Now you know why the drug company does not want to get too specific.
The commercial also mentions that “taking Jardiance with a sulfonylurea” may cause low blood sugar. Most people would not know whether they are taking a sulfonylurea drug unless it were named (chlorpropamide, glyburide, glimepiride, glipizide, etc). Nor would they realize that low blood sugar can be life threatening.
What we don’t understand is why the FDA lets drug companies get away with medical jargon or obfuscation.
What Is It Like to Experience Bad Drug Side Effects?
What is it like to experience a serious adverse drug reaction? A few years ago, we heard from a person who related a frightening situation as a side effect of a stop-smoking drug.
Chantix:
“My husband and I were both on Chantix to quit smoking back in June. Neither of us has a history of depression, but while on it he tried (with no warning) to take his own life.
“I tell everyone thinking about taking Chantix to make sure they talk to the doctor about ALL of the possible side effects. In rare instances, suicidal ideation and psychotic episodes may happen. That is stated in the prescribing information, which also says that depression and anxiety are frequent side effects.”
Other readers have reported similar problems with Chantix:
“After taking Chantix, I developed severe anxiety and depression. I tried to hospitalize myself several times but couldn’t be admitted because I did not want to kill myself or hurt others. I believe that something was triggered in my brain. To this day, I don’t want to kill myself but would not care if I died.”
Sometimes people are skeptical that the side effects listed would actually affect them. They may think that serious side effects are too rare to worry about.
Fluoroquinolines: Ciprofloxacin and Levofloxacin
Even when serious reactions are in fact rare, some people still experience them. For example, patients have developed aortic aneurysms while taking fluoroquinolone antibiotics (BMJ, March 8, 2018). This complication is rare, affecting 1.2 persons per 1000 people taking an antibiotic like ciprofloxacin for a year compared to 0.7 cases per 1000 person-years of individuals taking a different antibiotic, amoxicillin. Remember, though, aortic aneurysm is potentially lethal.
One reader wrote to us:
“My husband’s co-worker was prescribed Levaquin for walking pneumonia. Two days later, he was rushed to the ER in an ambulance because he had a ruptured aortic aneurysm. They told him if he’d arrived five minutes later, he would have died.”
We would suggest that fluoroquinolones be reserved for situations when other antibiotics are ineffective or inappropriate. However, not all prescribers agree.
Surprising Gabapentin Side Effects:
Over nine million people in the U.S. take gabapentin. This anti-seizure drug has been on the market for more than 35 years. You might think that all its bad side effects would have been discovered years ago. Au contraire.
On December 19, 2019, the FDA announced a “Drug Safety Communication:”
“The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.”
The FDA describes the seriousness of this ADE this way:
“What should patients and caregivers do?
Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:
• Confusion or disorientation
• Unusual dizziness or lightheadedness
• Extreme sleepiness or lethargy
• Slowed, shallow, or difficult breathing
• Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
• Bluish-colored or tinted skin, especially on the lips, fingers, and toes”
You can read more about Surprising Gabapentin Side Effects at this link. Be sure to read some of the 835 reader comments.
People’s Pharmacy Perspective on Bad Drug Side Effects:
Ideally, any time you get a prescription, you and your health care provider would discuss the benefits and risks. That way you could decide whether you want to accept the possible downside in order to get the value of taking the drug.
To help with that discussion, here are some questions to ask your doctor. They are taken from our book, Top Screwups. Should you wish to learn more about how to protect yourself from bad drug side effects, here is a link to that book:
Top 10 Questions to Ask Your Doctor When
You Get a Prescription
1. Is there another way to treat my condition besides this drug?
2. What is the evidence that this drug will produce a meaningful outcome, not just change numbers on a test?
3. How likely am I to get a benefit from this medication?
4. What are the most common side effects?
5. What are the most serious side effects?
6. What symptoms require me to contact you immediately?
7. How can I get through to you promptly?
8. How long do I need to take this medication?
9. How should I take this drug—with food or without, morning or evening?
10. Are there any special instructions for stopping this medicine?
Learn more about protecting yourself from adverse drug reactions, drug interactions, pharmacist errors and diagnostic disasters in Top Screwups.
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