Welcome to the first issue of FQ News — It’s just a sample of what you can look forward to receiving if you subscribe to the newsletter: The latest and most important news emerging about fluoroquinolones — safety issues, scary issues, scientific breakthroughs and more. News that impacts the lives of those who have endured pain and disability after taking a fluoroquinolone as well as those who want to protect themselves and their loved ones from possible injury.  Read on. . . and let us know what you think. - Marilyn Beardsley Heise, Editor

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.

If you have questions, comments, contributions or corrections relating to information you’ve read in this newsletter, we’d love to hear from you, so please email us.