“Floxxed” patients are calling for better consumer drug information.
APRIL GOODMAN had an appendix attack in 2015 and ended up in the hospital. Her appendix surgery wasn’t without its drama, but it was the drug that was prescribed afterwards that still haunts her to this day.
Speaking to me from her home in New Westminster, she tells me she was prescribed an antibiotic called ciprofloxacin (Cipro), one of a number of fluoroquinolone antibiotics (these are drugs that end in floxacin).
“No one—neither the doctor who prescribed it, nor the pharmacist who dispensed it mentioned a thing about the drug,” she said. She didn’t think anything about the drug’s safety either, until about a year and a half later when one of her back teeth broke.
“When I read that Cipro has caused dental problems, such as teeth breaking off at the gumline, and further dental problems, which can continue indefinitely, I was quite alarmed.”
What she uncovered in the course of several years of research is a truly astounding story of the floxacins, a widely popular class of drugs, wreaking devastation on an alarming number of people. She pointed me in the direction of a website, www.ciproispoison.com, where I learned a new word: “floxxed,” referring to a state of suffering from one or more of a long list of adverse effects related to this class of drugs.
It seems mind-numbing that a drug you might take for less than two weeks to deal with an infection could cause long-term, and for some, irreversible adverse effects. This has taken a long time to acknowledge.
April certainly wasn’t the first person to contact me about damages suffered due to fluoroquinolones. Over the last decade, I’ve had at least four different people write to tell me a tale of something truly horrendous, such as tendon rupture or retinal detachment, after taking a fluoroquinolone. Her concerns are echoed by official documents put out by various drug agencies in Canada.
A 2017 report issued by CADTH (the Canadian Agency for Drugs Technology in Health) said this: “The use of systemic [taken by mouth or by injection] fluoroquinolones is associated with serious adverse events, [including] effects on the central and peripheral nervous system, hypersensitivity, myasthenia gravis exacerbation [a chronic autoimmune disease], phototoxicity, QT prolongation [a heart rhythm disorder], and tendon rupture. Rarely, some of these adverse events have the potential to lead to persistent disabilities.”
Probably one of the more known risks of fluoroquinolones is its effect on tendons, which can sometimes become inflamed or even rupture. Health Canada warns that “rare cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported to Health Canada for fluoroquinolones.”
In the glib, somewhat bureaucratic way they issue drug safety warnings, Health Canada helpfully reminds health professionals of the patently obvious: “Consider the potential for disabling and persistent serious adverse events when choosing to prescribe a fluoroquinolone. Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with them. Stop fluoroquinolone treatment if a patient reports any serious adverse reaction.”
While there is growing public alarm at the overprescribing of antibiotics, fluoroquinolones can be effective if used properly. But they can also be terribly misused. WorstPills, an independent drug bulletin produced in the US, is direct and forceful in discussing the overprescribing of antibiotics in the US. It reports that “despite congressional hearings and numerous academic studies on this issue, it has become the general consensus that 40 to 60 percent of all antibiotics in this country are misprescribed. New studies continue to confirm the fact that a large proportion of antibiotic prescribing for both children and adults continues to be inappropriate.”
WorstPills singles out the fluoroquinolones as “one of the biggest-selling and most overprescribed classes of drugs in the United States,” noting that these drugs should only be used for those allergic to alternatives or those with an infection resistant to other antibiotics.
The problem here is typical of drug therapy—using the wrong drugs in the wrong patients and using fluoroquinolones for colds, sore throats, and bladder infections.
How poorly they are used was captured in a 2003 study carried out in two American academic medical centres. The researchers looked at 100 patients who were prescribed a fluoroquinolone in an emergency room. Of those patients, 81 received a fluoroquinolone for an inappropriate indication (a use not officially approved by the regulator). Of those 81, half of the prescriptions were “judged inappropriate because another agent was considered first line.” Worse yet, for a third of those 100, there was no documented evidence that an infection was even present.
In British Columbia, since the year 2000, when more than 150,000 patients were prescribed a fluoroquinolone, that number steadily increased until about 2010 when Health Canada started issuing the first of its warnings. Numerous programs have been launched to try to stem the inappropriate prescribing of antibiotics, including the public education campaign Do Bugs Need Drugs (www.dobugsneeddrugs.org). We are seeing that the number of patients who are prescribed fluoroquinolone antibiotics in BC has been steadily dropping since 2010. Yet even last year, almost 200,000 BC patients were dispensed a fluoroquinolone.
THE WARNINGS AROUND fluoroquinolones continue to mount ever since the USFDA, in 2011, required that fluoroquinolone antibiotics must be dispensed with a Medication Guide, which is essentially a consumer-oriented operator’s guide to your drug. While the FDA has the authority to order that Medication Guides be distributed in pharmacies (and given out to patients who are getting new scripts or refills), no such authority exists in Canada. The safety information Canadians receive on most prescribed drugs is almost certainly inadequate, as April Goodman learned the hard way. For anyone prescribed a new drug, an important question might be: “is there a Health Canada warning on this drug?”
Before new medicines hit the market, each country’s regulatory agency must first approve them for use, often based on limited safety evidence. After a drug enters general use, other safety issues can become apparent, including rarer or longer-term effects, prompting regulators to issue safety advisories on how to avoid or manage these risks.
Barbara Mintzes, a researcher originally from Vancouver but now working in the Faculty of Pharmacy at the University of Sydney, is studying drug safety advisories issued by regulators around the world. She is running an international study looking at drug advisories, and discussed her study with me in Victoria last month. In a research letter she published in JAMA Internal Medicine, she looked at, in total, 1441 drug safety advisories issued in four countries—Canada, Australia, the US and UK—over a 10-year period, covering 680 drug safety concerns. Sadly, Canada didn’t fare too well.
“Between 2007 and 2016, Canada’s drug regulator, Health Canada, issued safety warnings only about half the time related to issues identified by regulators in Australia, the US and UK,” said Barbara. “It’s concerning that all countries, including Canada, were seriously deficient in how they communicated emerging health risks of medicines.”
She added that there were nine fluoroquinolone warnings for the study period (from 2007 to 2016 inclusive), in all four countries: four from Canada, four from the US, one in Australia, and zero in the UK.
“Clearly if a drug has a safety advisory issued in one country, the same drug sold in another country should also come with similar warnings,” said Associate Professor Mintzes. “Overall, we found that regulators in these four nations were only consistent in the decision to warn 10 percent of the time.”
According to research from the Canadian Institute for Health Information, from 2006 to 2011, emergency department visits and hospital admissions due to Adverse Drug Reactions (ADRs) among seniors in Canada cost an estimated $35.7 million. Much of this is preventable. For Barbara Mintzes, the prescription is clear: “We would like to see much more attention paid to ensuring that doctors and patients are informed of new evidence of harmful side effects of medicines, and what to do to prevent them.”
April Goodman heartily agrees with that sentiment.
If there’s one thing I’ve discovered after looking closely at drug safety for over two decades, it’s that people who have been through a drug disaster often become the most knowledgeable educators about the issue. These citizen experts can and do help educate the people around them to the dangers that could come via a simple pill.
April Goodman, who has become extremely knowledgeable about fluoroquinolones, is a good example. She told me, “You have to be the CEO of your own health.”
As for possible damages to teeth, she’s disappointed that neither Health Canada nor the US FDA has added that specific warning to the labels for these drugs. She has collected numerous articles warning of the potential for dental harm. “Many people, even young ones, are losing their teeth and get dentures after this Cipro harm.” With all the dangers she’s become aware of, she thinks that it might be time to pull the plug on this entire class of drugs. “I don’t think this is something that should be still on the market now.”
Alan Cassels studies and writes about pharmaceuticals. He currently works at UBC.