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When Are Bad Drug Side Effects Worse Than Drug Benefits?

Have you ever experienced bad drug side effects? If you watch TV commercials you know that death is not considered an obstacle to FDA drug approvals.
Magnified focal area over the warning information of a prescription medication

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.

Share your own story in the comment section below:

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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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Top Screwups Doctors Make and How to Avoid Them
Citations
  • Moore, T. J. "Scope of Injury from Therapeutic Drugs," QuarterWatch Reports, Dec. 4, 2019, Institute for Safe Medication Practices, https://www.ismp.org/resources/scope-injury-therapeutic-drugs
  • Pastermak, B., et al, "Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study," BMJ, March 8, 2018, doi: 10.1136/bmj.k678
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Horrible experience with Doxycycline (one dose) and was horrified that a drug is increasingly being used that states “potential permanent blindness.” Blindness. Permanent Blindness!

My aunt donated her body to UNC. Did her medical/prescription history go with her? One year ago she was on 23 different prescriptions and on PPIs for years, etc. We got her off all but 7. I think that history would be valuable for research.

The FDA reporting system is a joke. I had a severe reaction to pravastatin and zetia and developed Polymyalgia. When I went online to fill out the form on FDA.gov I could not supply the info they wanted. None of the info they wanted was on my prescription bottle (Lot number, etc).
If you don’t have this info you cannot submit the form. I have to wonder how many adverse reactions are not reported because this type of info is not printed on presription bottles anymore

I had to take Gabapentin and noticed how fast my weight was going up. I took to walking every day for a month, 4 miles, didn’t notice any weight loss.Put more weight on instead. Also I was seeing things that were not there, didn’t feel go about my self. Then I did some research on the med and noticed that all of these symptoms were listed as side affects. I’m a herbal user, so I did research on what kind of herbs I could take to help my symptoms. I prayed to MY GOD AND SAVIOR for guidance and healing. I have been off the med for one month +, walking 4 miles daily, the weight is coming off, and I feel better. My health is in GOD’S HANDS. I will never take this med again.

You could write (and have written) an entire column about Tramadol (Ultram). In 1995 it was prescribed (by an allergist!) for my wife who had idiopathic ankle pain. After a few weeks she began having involuntary twitches. Over a period of a few months, this progressed to full-blown, fall-to-the-ground-with-arms-legs-and-head-thrashing seizures. She became unable to work, drive, or carry on daily activities. I had to leave her with a friend each day so I could work.

In those days you didn’t reliably get patient inserts from the pharmacist, so we had no idea what the cause might be. We went to eight different physicians, and none had a clue. The high-powered neurologist hospitalized her and filmed her all night and proclaimed she was faking. “It’s in her head. She should see a psychiatrist.” The allergist insisted that it could not be the Tramadol. It later turned out that none of the others had even asked what medications she was taking.

The situation resolved after a year–because I chose to look up Tramadol myself. Imagine my surprise when I found out that seizures occur in 5% of the patients! There is a Black Box warning about seizures on the patient insert–which we were never given. The seizures stopped twelve hours after the last dose–and the brain fog she had complained about lifted at the same time. It had cost a year out of her life.

The pharmacists don’t get off scot-free here either. I asked the pharmacist why he would dispense a drug known to cause seizures to a patient for whom he was also dispensing anti-seizure medication. His response was “It’s not my job to check that.” I seem to recall many statements to the contrary from the pharmacists’ association.

A few years ago I hurt my back and hip shoveling and ended up in the ER. I was given Toradol and ended up back in the ER because it wasn’t helping. My friend who drove me pointed out to the doctor that my blood pressure was very high, @ 188/122, and it was ignored. When I got the followup call by a nurse from the ER visit I told her my blood pressure was still very high and asked if I should stop taking the Toradol. She said I should ask my pharmacist!!?? My sister who is a nurse told me to stop taking it. Three days later I saw my doctor and my blood pressure was lower but still high, and I had swelling in my feet, ankles, hands, and face. She put in my records I was severely allergic and gave me steroids to reduce the edema. It’s crazy that an ER doctor and a nurse did nothing when they should have been able to find a doctor to tell about my reaction to this drug.

On December 28th, 2018 I had an IV infusion of Entyvio to fight off my Crohn’s disease. The next day I got the flu which is a side effect of the drug. It was the worst flu I ever had and included loss of memory. I have had the flu 15 times since then, and it has been a few days less than a year. Some bouts were milder but still included loss of bladder and bowel control. Others included severe loss of memory. I was asked for my cell phone number during one episode and not only did I not know it, I didn’t know what a cell phone was!

I spoke with the drug manufacturer and was told the drug would be out of my system about May 1, 2019 but my last episode in November sent me to the hospital for a week with pneumonia, a UTI infection and a kidney infection. Be careful of this drug. For me the side effects were worse than the disease.

A major part of the problem is the prescribing physicians are often willfully unaware of the actual frequency of, or do not believe that the occurrence of these “rare” side effects happens at all. When I asked about side effects of a new drug, my doctor said not to worry because if only one person reports a reaction they are required to list it, but the chances of it happening to me was highly unlikely, “and the benefits far outweigh the risks.”

An elderly friend’s nurse practitioner told her if she refused to take a statin drug, due to adverse effects, she would be dropped as a patient. After my 72 yr old husband died unexpectedly at rehab, I looked up the side effects of meds he was on. Several of them were specifically listed by the manufacturers as “not recommended for patients over 65!” And yet, the rehab “gerontologist” had decided the benefits outweighed the risks, without ever discussing it with either of us! The doctors we trust with our lives have betrayed their responsibility to “first do no harm!”

I’ve noted a new one recently. “May cause changes in lab values” which I assume is a euphemism for May cause liver and/ or kidney damage. I personally don’t think the F DA or big pharma cares about ANYTHING but making obscene profits and the term FDA approved means nothing to me.

My wife was diagnosed with a hereditary gait disorder (based on something I said that was I think misinterpreted) and prescribed baclofen for spasms. A side effect was small seizures. Rather than stop the baclofen the neurologists office prescribed an anticonvulsant (I cannot remember the name) and after three days of taking it my wife could not walk at all and was in the hospital with a sprained ankle and then a nursing home for a couple of months. The neurologist switched her to Zonisamide after she went to the hospital and would not let us stop taking the medication when we tried about 9 months later. Another doctor helped us by saying he could not tell us to stop but told us how if we wanted to. Interesting bit of information is the gait problems correlate pretty well with starting to take statins but came on gradually so who knows.

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