He tells of prescribing, as a resident, a fluoroquinolone antibiotic to a woman suffering a bladder infection. The patient later told him that after taking it, her Achilles tendon had ruptured. “What? I thought. “How on earth can an antibiotic do THAT? I went back and researched it. Sure enough, a spontaneous tear of the Achilles tendon was a well-known complication, one of the many I had underappreciated.”

The incident led Makary to take a deep dive into the complications of prescription antibiotics and how they affect our gut microbiome by killing the good bacteria that keep us healthy. His resulting research uncovered several disturbing facts about antibiotics that he discovered in sound scientific studies:

• Half of all antibiotics prescribed in the U.S. are unnecessary.

• 20% of hospitalized patients treated with an antibiotic will experience an adverse effect.

• By the age of 3, the average American child has already taken about four courses of antibiotics.

• (In Pakistan, a two-year-old has already received 10 antibiotics!).

• Children who took antibiotics grew up to have much higher rates of obesity, learning disabilities, asthma and celiac disease than those who did not take them.

• People who took five or more courses of antibiotics were 53% more likely to develop diabetes.

• A doctor is far more likely to prescribe an antibiotic in a telemedicine visit than in person.

These issues appeared in only one chapter of Blind Spots. The author also confronts issues with the child peanut allergy epidemic, silicone breast implants, and other damaging medical dogma that was the result of intrenched and dangerous decision-making by scientists, researchers, and the medical community. You may not agree with every issue Makary confronts in this book, but you’ll find the discussions do raise concerns and suggest more scientific research and evidence is needed.

Dr. Makary has done his homework. If named to head the FDA, will he apply his knowledge of FQs and antibiotics with advocacy for change to the decades-long damage that fluoroquinolones have caused so unnecessarily to a estimated one million U.S. patients that have already suffered serious adverse events? We’ll have to wait and see. . .

FQ experts and some victims have tried to draw attention to the fact that 1.2 million prescriptions for Cipro were distributed to military facilities for soldiers who were deployed to the Gulf War.  The purpose of administering this antibiotic was to “prevent being affected by an anthrax attack,” according to the VA, even though Cipro’s effectiveness against anthrax is unproven. (There has never been a large enough population of anthrax victims to conduct a proper clinical trial.) 

Symptoms suffered by one third of these soldiers are the same as those who have had reactions to Cipro -- fatigue, pain, harm to the central nervous system and muscles, gastrointestinal disorders, fibromyalgia and more.  Still, there was a perceived threat that Saddam Hussein might release a large supply of anthrax in a biological war.  Cipro was thought be an antidote. 

There have been no studies on the connection between GWI and Cipro, even though the adverse effects of both are so similar.  

Shouldn’t there have been an investigative study about Cipro’s possible connection to this unexplained wartime illness? Why has the VA not pursued this possibility?

A study and investigation are long overdue. 

The well-known journalist was reporting on the world-watched soccer games when he developed a cold that became increasingly worse. He said he finally went to the facilities’ healthcare center, was diagnosed with “probable” bronchitis and given antibiotics. A few days later, he collapsed and died.

Was Wahl given a fluoroquinolone antibiotic?  Physicians frequently prescribe fluoroquinolone antibiotics for bronchitis. As most of us know, they should be given only after confirming that the patient has a bacterial infection and not a virus.  It seems unlikely that he was tested for bacteria first since results would have taken hours or days to come back. In Wahl’s own words:

“My body finally broke down on me. Three weeks of little sleep, high stress and lots of work can do that to you. What had been a cold over the last 10 days turned into something more severe on the night of the USA-Netherlands game, and I could feel my upper chest take on a new level of pressure and discomfort. I didn’t have Covid (I test regularly here), but I went into the medical clinic at the main media center today and they said I probably have bronchitis. They gave me a course of antibiotics and some heavy duty-cough syrup, and I’m already feeling a bit better just a few hours later. But still:  No bueno. “

Futbol with Grant Wahl,
December 5, 2022   

 Here’s what we know:

• Fluoroquinolones are frequently given off-label for disease and conditions that are not approved by the FDA such as viruses, for which they are not at all effective and may cause harm. Labels include these warnings.

• The FDA has issued a warning that fluoroquinolones may cause aneurysms.

• According to the American College of Chest Physicians, less than 10% of acute bronchitis cases are due to a bacterial infection and, consequently, should not be treated with an antibiotic.

• Wahl’s wife was shocked, she said, because Wahl was “a very, very healthy guy” who worked out with a trainer and used a rowing machine a few times a week. 

Healthy, fit, had “possible” bronchitis, not tested for bacterial infection, given powerful antibiotics anyway.

Could this unfortunate death have been caused by a medication? Could Dr. Gounder release the name of the antibiotic her husband received? That information would quash any speculation that a medication might have caused his untimely death.

If, indeed, Wahl was taking a fluoroquinolone prior to his death, an announcement could become an important teaching moment. Knowing that Wahl’s unlikely passing might have been due to a drug reaction would present an opportunity for his widow to create worldwide awareness about the risks of aneurysm associated with fluoroquinolones. Wahls death was broadly-covered by the media.

It would be a major gift to medicine in his memory.

“What this paper does is examine the evidence that was used to make these policies in the first place and as a result call for a global harmonization of the safety warnings,” said Dr. Robert Baldock, School of Pharmacy and Biomedical Sciences at the university.  

“As adverse reactions can be diverse and underreported, one of the challenges is identifying the number of serous adverse events there are, or have been,” he added.  “So many patients who report chronic fatigue, pain or psychiatric problems either remain undiagnosed or misdiagnosed.”

The U.S Food and Drug Administration (FDA) recognizes that these antibiotics potentially have a permanent toxicity and advise doctors not to prescribe them as a first line therapy or unless absolutely necessary.

Other authors include Dr. Cecilia Bove of York College, and Oscar Champigneulle, Linda Martin and Dr. Charles L. Bennett of the University of South Carolina.

Perilous Pills author, Marilyn Beardsley Heise sent Letters to the Editor at the Portland Press Herald about FDA Black Box Warnings and Hospital Overprescribing. Both were printed. One elicited a surprise response.

Read them here:

OK of ‘black box drugs should draw scrutiny
April 5, 2022

The Food and Drug Administration’s rush to approve new medications is only one important issue that should be addressed concerning Washington’s drug regulatory agency. The FDA is part of the Federal Department of Health and Human Services and yet, its decisions are not always so healthy.

Take fluoroquinolones, for example. This powerful class of commonly-prescribed antibiotics includes Levaquin and Cipro as well as many generics.  FDA approved them in the 1980s for serious or life-threatening bacterial infections and cautioned against giving them to the elderly. However, millions of these pills are prescribed worldwide every year off-label for less serious illnesses such sinus infection, or even Covid, a virus, which they are not even effective against. Still, they have caused disabling adverse events and even death to hundreds of thousands of patients in the U.S. alone, not to mention worldwide where use is also widespread.  U.S. events are documented at the FDA’s own MedWatch site, where only 1 percent to 10 percent are reported, according to the agency.

Since approval, the FDA has issued seven medical alerts for fluoroquinolones called “black box warnings.”  These were sent to physicians and medical institutions warning that fluoroquinolones could cause rupture of the Achilles tendon, tearing of the rotator cuff, retinal detachment, peripheral neuropathy, seizures, aneurysms, aortic rupture, suicide and more.  Some patients have experienced lifelong injuries. As a result, in 2015, the FDA recognized Fluoroquinolone Associated Disability (FQAD) as a syndrome.

Unfortunately, black box warnings are rarely read by doctors, making them less than effective.  Losers are patients, who take their medicines unaware of the unnecessary harm they might cause. 

Why aren’t we asking the FDA why it is approving drugs that need so many follow-up warnings about incredible injuries and even deaths that they may cause?

 

Marilyn Beardsley Heise
Author, “Perilous Pills: Protecting
Yourself from Fluoroquinolone Injury

Overprescribing fuels opioid deaths
July 31, 2022

[Photo of OxyContin pills with caption: A reader says her recent experience at a Maine hospital shows that these powerful painkillers must be prescribed with more consideration.]

There is another reason why people are dying from opioids (Our View: “Overdose deaths driven by dangerous supply,” July 17). It is well-known that many unsuspecting patients have become hooked because they were prescribed these powerful painkillers by their doctors or hospitals.  Not only prescribed, but over-prescribed. 

After a recent small surgical biopsy at a respected Maine hospital (Central Maine Medical Center, Lewiston), I was sent home with a prescription for 55 opioid pills! There was no discussion about this drug or pain evaluation before discharge. I took two Excedrin that night and I was done with any discomfort.

This kind of overprescribing became common after pharmaceutical companies pervasively and persuasively marketed these meds as the latest and most effective pain killers. Physicians and institutions responded and prescribed them by the millions. 

The Editorial Board states “As the deaths mount with no relief in sight, we can’t reject ideas that could save lives.”  How about this idea?  Hospitals and doctors must stop the overprescribing of these potent drugs which can lead to devastating addiction and death. 

Marilyn Heise,
East Boothbay

 

This reader responded.

Unneeded prescriptions add to costs, dangers
Portland Press Herald, Letters to the Editor — August 7, 2022

I just finished reading Marilyn Heise’s July 31 letter to the editor, “Overprescribing fuels opioid deaths”) and had to chime in with my own experience.

I had minor internal surgery over a year ago at Maine Medical Center in Portland. I awoke feeling really good. The doctor gave me all the usual post-surgical advice, and a prescription for oxycodone. I told him emphatically that I did not want them, nor would I take them.

He kept pushing it because I might need them after getting home, and I again said “no.”  When my daughter picked me up, I had a paper bag in with my belongings that I didn’t notice, but you guessed it – a bottle with 10 pills in it!

I am still irate just relaying this. Think of the costs for every patient routinely getting these unnecessary and dangerous pills! I then had to find out a safe way to get rid of them. When will the doctors hear and respect the patient!

Rosemarie Fitch,
New Gloucester

 

Of a total of 9,098 GI events reported after taking Cipro/ciprofloxacin, 87.30% were called serious and another 12.98% were disabling.  Of the 7,283 GI cases after taking Levaquin/Levofloxacin, 88.40% were serious and 10.68% were disabling.  Other drugs that resulted in significant numbers of gastrointestinal disturbances were Avelox/moxifloxacin, Norfloxacin, Lomefloxacin, and Ofloxacin, the latter receiving the highest number of deaths at 13.46%.

Researchers concluded that this data suggests GI disorders other than nausea, diarrhea and vomiting should be included in product labels for all FQs, and that serious side effects should be considered uncommon side effects.  Further, the authors recommend that physicians and especially gastroenterologists should become more aware of the dangers of Fluoroquinolone Associated Disability (FQAD) syndrome and consider that serious GI events are associated with taking these powerful drugs.

Could Fluoroquinolones Be Causing Some Covid Long Haul Signs? 

Symptoms of Long Haul Covid are seen in 37% of all Covid patients, according to a large Oxford University study. Those symptoms are very similar to those experienced by patients who say they have been floxed (adversely affected) by fluoroquinolones (FQs). They include fatigue, muscle and joint pain, anxiety, brain fog, limb numbness, thoughts of suicide, and more. This study found that symptoms were more frequent among people who had been previously hospitalized with Covid. Consider that other research shows most pandemic patients are given fluoroquinolones upon admittance. Then make the connection: It seems highly-likely that some of those Long Haul reactions may be caused by medication. 

The Australian National Phenome Centre recently found that these same symptoms were seen in more than half (57%) of all non-hospitalized patients three months after the acute disease phase. Although there is no research to date, it seems likely that those who suffered at home instead of in the hospital might also have been prescribed FQs by their physicians. The possibility of a Long Haul-FQ connection deserves study.

FQs for Surgery?

It’s true. Most people are unaware that fluoroquinolones are used in surgical procedures including Lasik eye surgery. Are they necessary? Only when bacteria are present, for which they are effective. In addition, they are often given in hospitals as disease prevention, for which they are entirely ineffective unless there is bacterial infection. This is called overuse and exposes you to unnecessary risk. Whenever you or a loved one is hospitalized, always ask what medications you are being prescribed.

Is Your Doctor Licensed to Practice Telehealth?

With the rise in telehealth services during the past year, physicians are giving advice and practicing medicine with more and more patients, maybe even you, via the internet. If you’re getting advice and care through online services, beware.  Find out whether your online physician is licensed to practice telehealth in the State where you live. Waivers were issued to doctors during the pandemic but they are set to expire. Best advice is to seek healthcare from a doctor you know and trust.

Now it’s Acute Liver Injuries!

A nationwide study in Sweden has found a two-fold increased risk of acute liver injuries associated with oral fluoroquinolones in the first two months after starting treatment. Investigators researched prescriptions for patients 40 to 85 years-old from 2006 to 2014. We know the risks. Why aren’t doctors and other medical providers getting the message?

The Trouble with “Polypharmacy”

The volume of available meds has grown so large, doctors can’t possibly know offhand all the potential interactions between drugs. Prescribing multiple drugs at the same time to treat a single ailment or condition is known as polypharmacy. It’s frequent and troubling. Troubling, because there can be dangerous interactions between drugs. On a Newsmax TV interview, Dr. David Brownstein said: “If a doctor prescribes ciprofloxacin to treat an infection, he or she should be aware that Cipro can be associated with dozens of side effects, including interactions with other drugs, and other serious reactions that can cause fatal heart arrythmia.” Information on drugs is broadly available, he added, but physicians may not have the time or will to check it out.

Damage to DNA Persists Years After Exposure to FQs

Decades! Who knew that DNA damage is detectable decades after exposure to fluoroquinolones? Researchers at the Facebook group Fluoroquinolone Toxicity Study NFP found that DNA changes occurred in patients whether FQs were given orally, via IV, or even with ear drops. All individuals tested showed change. The group’s lofty mission is to study patients’ cells after FQ exposure in the hope that results may lead to therapies as well as prevent adverse reactions to these powerful drugs. You can support their efforts by donating generously or as much as you can at their website fq100.org.

How Many Physicians in the US are Employed by Hospitals?

More than one-third, according to the July issue of the Journal of the American Medical Association. Hospitals are now driven largely by an economic model where razor-thin profit margins depend on highly-reimbursed elective procedures brought in by their doctors. Hospitals lost money during the Covid-19 pandemic because most elective procedures were cancelled. Doctors must abide by restrictions on their practice required by their new bosses. It’s a new world of medical practice that affects every patient’s care.

FQs as Chemotherapy Drugs?

Is it any wonder? We know that fluoroquinolones can be damaging to the human body. But did you know that they are powerful enough to be used in chemotherapy? FQs are topoisomerase interrupters just like other chemo drugs, but they are not listed as being chemo drugs. Still, they are used because they are powerful and it is believed they may have the ability to possibly kill or change cancer cells. If there is proof of this, however, I have not seen it. Know your risks if you or a loved one is entering chemotherapy.  We would advise discussing with your doctor what meds will be given with chemo and why. Hopefully, that doctor knows about fluoroquinolones and can recommend whether they should be included in your cancer therapy. Be sure he knows if you have had a previous reaction to a FQ. You don’t want surprise repeated reactions. 

Think You Should Trust Drug Information Leaflets?

Think again. Those information sheets you get with your drugs at the pharmacy are not the same as your doctor receive.  They get “professional label” information that we never see. Our leaflets are unregulated and historically have failed to provide consumers with useful, scientifically accurate information about the safety and effectiveness of medications, according to med advocate Worst Pills, Best Pills.

Ah, but we can now access those professional drug label information guides through dailymed.nlm.nih.gov/dailymed/. The website offers a complete up-to-date database of drug labels. Or, just ask your pharmacist for the drug information piece that your doctor or other medical personnel receive.

Watch What You Read

Sometimes headlines can be misleading. For instance, take a recent headline and frequently-picked up news item that “Third-generation fluoroquinolones (are) not linked to Achilles tendon ruptures.” Wow. Sounds like a breakthrough, right? But what the study actually revealed was this: Use of third-generation FQs were “not associated with an increased risk for Achilles’ tendon ruptures.” In other words, it seems, the new generation of FQs are no better and no worse than older fluoroquinolones. The headline, the entire story is deceiving and suspicious. Still, it was widely-distributed as a breakthrough.

Until we chat again. . . Stay well. Stay safe.

For more information, read about FQ patient stories and critical medical issues you should be aware of in Perilous Pills, Protecting Yourself from Fluoroquinolone Injury, available at Amazon or in bookstores. If you have comments or want to get in touch, email me at perilouspills@gmail.com.

Stay Up-to-Date on Fluoroquinolone Issues by Subscribing to FQ News. Click HERE to subscribe for FREE.

It’s official. March 24 will become an annual National Adverse Drug Event Awareness Day. Led by the American Society of Pharmacovigilance (ASP), the organization hopes “to spark a national discussion of the ongoing tragedy and staggering healthcare costs directly related to adverse drug events (ADEs).” ASP launched a national awareness campaign to encourage victims of ADEs (that’s us) to share their stories. begin building community support, and urge healthcare professionals and organizations to talk about how they can champion medication safety. ASP reports that adverse events are “the 4th leading cause of death in the United States.” Visit www.facebook.com/AmSocietyPharm/ and share your story.

The best news I’ve heard of in a long, long time! The esteemed drug safety expert Dr. Charles Bennett has brought a whistleblower lawsuit with the Justice Department against the makers of Levaquin and Cipro, accusing them of fraud against Medicare, Medicaid and other government programs by making false statements and misbranding these fluoroquinolones. The suit accuses pharmaceutical giants Johnson & Johnson, Bayer and Merck. It is estimated that at least 60% of Levaquin and Cipro prescriptions are for Medicaid and Medicare patients.  
The lawsuit argues that decisions by these companies are troubling because the drug makers were fully aware and on full notice of the risks of FQAD (Fluoroquinolone Associated Disability) and possible mitochondrial toxicity and knowingly disregarded federal laws and FDA regulations about suppressing the harmful effects of Levaquin and Cipro. You can read our media release about it on the Perilous Pills Blog.

There’s more. It’s come to my attention that there are two other significant class action lawsuits being brought against Janssen and Bayer in Canada claiming serious health effects as a result of fluoroquinolone use. Those adverse effects include peripheral neuropathy and Achilles tendon damage. I’ll keep you updated.

Time to Listen Up! Victims of fluoroquinolone toxicity say they try to talk about their debilitating symptoms to family, friends and doctors, but few believe them. The best listeners are FQ Facebook groups and other supportive sites. Here are a few of many recent disturbing posts about FQ experiences that I ran across, including pickings from nearly 60 shoutouts on one site:

“I have a UTI that is resistant to certain antibiotics. My doctor offered me Cipro. I refused. She called me difficult.”

“Was on Levaquin three different times for three different infections. I have tendon tearing on both my thumbs and wrists. Forty-one years old.”

“Just curious how many people here are completely bedridden? I don't know how to survive this...my body is coming apart at the seams more and more with each passing day without me even doing anything to deserve it. Every little move I make, I tear.”

“Took Ciprofloxacin for a prostate infection. And now I can barely walk.”

“I took Levaquin on April 17, 2009, by the 20th I was so ill I could not stand, open eyes, chronic/screaming pain, muscle twitches, insomnia, hearing sensitivity.”

“So they gave my 90 year old grandfather Cipro. You heard me. My grandmother doesn’t listen to me at all. He only had a few doses before he broke out into a full body rash.”

“Just got floxed over a week ago, it feels like Lyme Disease all over again. I have severe tendonitis, hip bursitis, pain in knees, hands, and feet, terrible headache and popping of joints.” 

“It is truly lonely and awful when people close to you do not believe what you are going through because they have not heard of this condition.” 

My sympathies are with every one of you.

Did you know that there are only two countries in the world that allow advertising of prescription drugs directly to the public? New Zealand and the United States. Could it be this is one of the primary reasons for the enormous sales and profits that America’s pharmaceutical companies enjoy? Lack of price negotiation is a major reason, of course. However, it doesn’t take a brain surgeon to notice the ubiquitous drug ads that flood American television and other information sites. “Ask your doctor” ads encourage overuse and unnecessary prescriptions. It’s time to end this exploitation.

I was happy to read the results of stewardship studies published recently in JAMA Internal Medicine. One showed that FQ use dropped following the FDA’s 2016 safety warnings and a label change. According to this research, there was immediate reduction in FQ use for UTIs (-7.2%), for COPD (-2.6%) and for acute sinusitis (-1.2%) with declines continuing monthly thereafter. Other research showed that from 2015-2019 overall FQ use declined annually at 10.8%. That sounds like good news. Or at least it seems. But there’s the other side of the coin. Fluoroquinolone sales are anticipated to increase by 5.3% globally by 2028, according to a leading market report. Usage is dropping in some disease areas, but overall sales of FQs are continuing upward. What’s wrong with this picture?

Can you guess what a DID means? It’s what medicine calls a Drug Induced Disease. One physicians’ information site called MDLinx recently pointed out that fluoroquinolones are one of five drugs that can cause disease or worse. FQs were selected because they can cause heart arrhythmia (uneven heartbeat) or sudden cardiac death. Let’s hope that doctors will pay attention to this.

Medical Gaslighting. It’s what happens when a doctor or medical professional dismisses or trivializes a patient’s health concerns based upon assumptions that they are mentally ill. The term originated with the 1944 movie “Gaslight,” wherein the husband, Charles Boyer, convinces his wife, Ingrid Bergman, without evidence that she is mentally disturbed. When “gaslighting,” physicians may tell a patient “it’s all in your head.” It’s a common practice if patients are injured by FQs.

Hospitals need to severely reduce FQ prescribing. That’s the conclusion by The Pew Charitable Trusts which partnered with the Center for Disease Control in a recent study. Their research indicated that 47% of all fluoroquinolones given in U.S. hospitals were inappropriate. Close to 60% of patients receive antibiotics when they are hospitalized; most are FQs. To reduce inappropriate use, hospitals need to provide antibiotics only when needed and prescribe appropriately, that is, give the proper drug at the correct dose for the right duration.

Know Your Drugs Tour. A major drug safety awareness campaign is being organized in Canada by leading advocates David Carmichael and Mark A. Girard. If Covid cooperates, according to Carmichael, a four-month cross-country tour of Canada will promote drug safety beginning in July. It will end in Victoria on November 6, which is Know Your Drugs Day and the 7th anniversary of Vanessa’s Law ( also known as the Protecting Canadians from Unsafe Drugs Act). Tune in for more information at KnowYourDrugs.org and perilouspills.com.

Want more information? Visit perilouspills.com or purchase the companion book Perilous Pills: Protecting Yourself from Fluoroquinolone Injury available from Amazon or in bookstores. And don’t forget to recommend subscribing to FQ News to anyone who could benefit.

If you have comments or just want to get in touch, email us at perilouspills@gmail.com. 

The lawsuit claims fraud against the government by Johnson & Johnson, Bayer and Merck for making false statements and misbranding fluoroquinolones (FQs) for use in Medicaid, Medicare and other federal programs.  Bennett’s suit accuses the companies of misbranding, marketing, promoting and introducing these drugs through interstate commerce without warning on the labels that consuming them may result in Fluoroquinolone-Associated Disability (FQAD) and mitochondrial toxicity.

“This is significant action taken by a leading advocate of drug safety to call attention to the misdeeds of three pharmaceutical giants who have been causing unnecessary harm to patients for decades,” said Marilyn Beardsley Heise, author of Perilous Pills, Protecting Yourself from Fluoroquinolone Injury.  “Fluoroquinolones can cause disability or psychological impairment, sometimes for life.”

Since the 1990s, hundreds of millions of prescriptions have been written for fluoroquinolones to treat pneumonia, sinusitis, bronchitis, skin infections, prostatitis, urinary tract infections and kidney infections. It is estimated that at least 60% of these prescriptions were for Medicaid and Medicare patients.

The lawsuit argues that decisions by these companies are troubling because the drug makers were fully aware and on full notice of very serious adverse events based upon Dr. Bennett’s extensive research, the FDA’s MedWatch reporting system, other FQ research, FDA pharmacovigilance review reports, FDA advisory committee meeting discussions and two citizen petitions submitted to the FDA.  Bennett claims the companies ignored information in numerous reports, studies and hundreds of patient reports submitted to the FDA.

The legal action further argues that these companies ignored the science and continued to stand by Levaquin and Cipro as labeled. As a result, the suit claims that healthcare providers continued to prescribe Levaquin and Cipro without warning patients of the risks of FQAD and possible mitochondrial toxicity. In addition, they knowingly disregarded federal laws and FDA regulations about suppressing the harmful effects of Levaquin and Cipro.

The legal dispute claims that these companies fraudulently obtained billions of dollars from the federal government that unjustly enriched themselves at the expense of taxpayers and at risk of patient health. Further, by continuing this fraud, the companies exposed and continue to expose many individuals who could have been spared FQAD and mitochondrial toxicity if they had acted in accordance with the law and with FDA regulations.

Dr. Bennett is a noted advocate for drug safety and has spoken and written extensively about the risks of taking fluoroquinolones.

P.S. If you want to receive future issues of FQ News — and I hope you do —you can subscribe to the newsletter by clicking here. 

P.P.S. Want more information on how fluoroquinolones came to be such blockbuster drugs? I encourage you to pick up my book Perilous Pills: Protecting Yourself from Fluoroquinolone Injury on Amazon. It’s the result of my own harrowing experiences with these drugs and the six additional years I spent researching and writing to stop it from happening to others.

What’s the risk of having an aortic aneurysm,.. which can be deadly, after taking a fluoroquinolone if you are simply 35 or older?  Apparently, there is increased risk beyond an FDA warning in 2018 that aortic rupture could be caused by fluoroquinolones only in people with high blood pressure or a history of blockages or artery issues. Recent research out of the University of North Carolina at Chapel Hill, led by Melina R. Kibbe, MD, FACS, FAHA, found that there was a link to this larger population.  More than 9 million prescriptions were studied and 6,752 cases of aortic aneurysm had occurred within the next 90 days after taking a fluoroquinolone.  Although the risk is small, said Kibbe, 20% appeared more likely to suffer a rupture than those who didn’t use a fluoroquinolone. Kibbe suggested that doctors should be more careful about writing fluoroquinolone prescriptions, even for patients who are not at high risk. Good idea.

Don’t want to hear this!  Fluoroquinolones and broad spectrum antibiotics are expected to lead sales growth of all antibiotics in a global market that will generate revenues of $58,798.1 million [sic] by year 2027.  The fluoroquinolone segment, in a study by Research Dive, is expected to garner the highest revenue of all, reaching $10,143.1 million in sales by 2027, compared to $6,823.1 million in 2019.  North America is predicted to dominate antibiotic sales due to higher prescribing among other factors.  Researchers said the high growth of fluoroquinolone prescribing is because they are seen as “extremely effective” and that they enjoy a “large volume of distribution.”  Looks like we are going to see greater numbers of patients worldwide experiencing adverse events.  

No Surprise Here! U.S. drug prices were more than double those in dozens of countries as recently as 2018.  A new analysis, reported by Stat Today, found that prescription drug prices were on average 2.5 times more expensive in the U.S. than in 32 other countries.  When a brand name drug was counted, that gap grew to 3.4 times more costly.  

Could telehealth be driving antibiotic misuse?  The National Health Service in the U.K. said there was a 270% increase in telephone appointments in the first five months of national lockdown in 2020 and that antibiotic prescribing rates were higher during remote medical consultations compared to in-person appointments, as reported in The Lancet Infectious Diseases. In the same article, Lancet also noted that there is growing concern that COVID-19 might be contributing to antimicrobial resistance. There was evidence that 70% of patients with COVID-19 receive antibiotics when conditions don’t indicate a need for them.  

It’s about time.  A federal watchdog agency recently issued an unusual warning to the pharmaceutical industry to avoid using kickbacks – specifically under the guise of so-called speaker programs – to entice doctors to write more prescriptions.  The Office of Inspector General at the Department of Health and Human Services strongly advised drug makers to think twice before rewarding high-prescribing doctors with speaking engagements and conditioning those talks on payments that include prescribing targets. The agency also warned against holding programs at venues that are not conducive to education such as high-priced restaurants, wineries or golf clubs. 

Insight into Eyesight:  By 2024 Fluoroquinolones will become the largest drug segment to treat bacterial conjunctivitis, a common eye infection, according to a recent post on Eurowire.  Value of the market will be $439.8 million. There are about 5 million acute bacterial conjunctivitis cases reported in the U.S. each year and the incidence is increasing.   Although other drugs can be given for this condition, fluoroquinolones dominate the market.  Little is known about the side effects or damage done by fluoroquinolones in eye treatment. Reports of eye injury suspected to be caused by these drugs abound on the internet and in patient advocacy groups.

Do you Google symptoms before consulting your doctor? If so, you’re not alone. A new survey found that 59% did just that. As a consequence, however, a significant number had a condition that went undiagnosed by a doctor for quite some time.  Meanwhile, 45% of individuals between the ages of 16 and 24 bought medication based on the diagnosis from “Dr Google.”  Another 33% between 25 and 44 did the same, according to Pharmaphorum.  

Who knew?  Leading drug safety expert Dr. Charles L. Bennett and a team of researchers just released results of a study of 15 drugs, including Levaquin and Cipro, and one medical device that revealed there were exceedingly negative consequences for patients, clinicians and manufacturers when very serious adverse drug reactions (ADRs) had been reported to the FDA. Among the highlights:

• 61% reported harms including verbal threats from manufacturers, and one lost a faculty position after reporting ADRs.

• It took an average of 7.5 years for ADRs to be reported to the FDA.

• It took another average of 7.5 years before the FDA issued warnings or removed one of the studied drugs or device from the market.

• 753,900 patients were awarded $38.4 billion in legal settlements by manufacturers for injuries purportedly caused by these 15 drugs and one medical device.

To qualify for the study, each item had to have generated at least $1 billion in sales, be identified as having high toxicity effects, have had very serious adverse effects reports, have generated at least $1 billion in legal settlements, had to have been considered for market removal by the FDA at one time, or have injured 1,000 or more patients. Because the impacts of ADRs are so large, researchers concluded that independently-funded pharmacovigilance centers of excellence should be established.

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Researchers had proposed a novel idea to the FDA for the creation of a Drug Facts Box that would act like a “nutrition label for prescription drugs.” The brainchild of Dartmouth professors Steven Woloshin and his late wife, Lisa M. Schwartz, the Drug Facts Box was envisioned as a one-page sheet that doctors would give to patients that could simplify and clarify the lengthy and sometimes confusing information that appears in consumer drug ads and medication guides that patients receive at the pharmacy.

Alas, the FDA opted not to move forward with the Drug Facts Box citing that “developing a useful, accurate box would be difficult for some prescription drugs.”

What’s the risk of having an aortic aneurysm, which can be deadly, after taking a fluoroquinolone if you are simply 35 or older? Apparently, there is increased risk beyond an FDA warning in 2018 that aortic rupture could be caused by fluoroquinolones only in people with high blood pressure or a history of blockages or artery issues. Recent research out of the University of North Carolina at Chapel Hill, led by Melina R. Kibbe, MD, FACS, FAHA, found that there was a link to this larger population. More than 9 million prescriptions were studied and 6,752 cases of aortic aneurysm had occurred within the next 90 days after taking a fluoroquinolone. Although the risk is small, said Kibbe, 20% appeared more likely to suffer a rupture than those who didn’t use a fluoroquinolone. Kibbe suggested that doctors should be more careful about writing fluoroquinolone prescriptions, even for patients who are not at high risk.

Leading drug safety expert Dr. Charles L. Bennett and a team of researchers just released results of a study of 15 drugs, including Levaquin and Cipro, and one medical device that revealed there were exceedingly negative consequences for patients, clinicians and manufacturers when very serious adverse drug reactions (ADRs) had been reported to the FDA. Among the highlights:

• 61% reported harms including verbal threats from manufacturers, and one lost a faculty position after reporting ADRs.

• It took an average of 7.5 years for ADRs to be reported to the FDA.

• It took another average of 7.5 years before the FDA issued warnings or removed one of the studied drugs or device from the market.

• 753,900 patients were awarded $38.4 billion in legal settlements by manufacturers for injuries purportedly caused by these 15 drugs and one medical device.

To qualify for the study, each item had to have generated at least $1 billion in sales, be identified as having high toxicity effects, have had very serious adverse effects reports, have generated at least $1 billion in legal settlements, had to have been considered for market removal by the FDA at one time, or have injured 1,000 or more patients. Because the impacts of ADRs are so large, researchers concluded that independently-funded pharmacovigilance centers of excellence should be established.

Dentists mistakenly believe that antibiotics, including fluoroquinolones, will prevent infection from bacteria in most patients if given prophylactically prior to dental procedures. However, a federally funded study showed that more than three-quarters of these drugs prescribed before dental procedures were unnecessary.  Dentists are the fourth most frequent prescribers of oral antibiotics in the U.S., accounting for one in 10 pharmacy prescriptions.

A U.S. database of medical claims from 2011 to 2015 identified 168,000 dental visits in which 91,000 patients had received an antibiotic within seven days before the dental visit despite the patients having shown no history of hospitalization or infection outside of the mouth.  Median age of these patients was 63 years, 57% of them were female and 43% were male. 

The study, reported in the Worst Pills Best Pills Newsletter, noted that inappropriate use of antibiotics for dental procedures not only contributes to the problem of antibiotic resistance but also exposes patients to increased risk of diarrhea and other adverse events. Conditions for which antibiotics are appropriate are 1) when the patient has an artificial joint or heart valve, has a heart transplant, a history of endocarditis, or has a certain type of congenital heart disease and 2) when the patient will undergo gum or root canal work or perforation of the mucous membrane.  

Advice:  Discuss this study with your dentist and cardiologist if you are considering invasive dental work and whether you really need that antibiotic.