We all know that antibiotics are not good for us for one reason or the other. We are allergic to some, the bugs love others and get fat on them, and then there is a class that actually works quite well, a broad spectrum class that can kill both gram+ and gram- bacteria (these are stains that make them visible under microscope) but… and here is the problem. Many of us get this particular class of antibiotics because they work so well but it was just brought to my attention that this drug class has two black box warning on it!
What is a black box? It is a special warning “… reserved for prescription drugs that pose a significant risk of serious or life-threatening adverse effects, based on medical studies…” as per the American Society of Consultant Pharmacies. Usually black box warnings are associated with psychotropic medications of the worst kinds (by worst I mean possibly causing the most danger) but who would expect one on a class of drugs we get for simple bacterial infections? In fact there are 36 drugs listed in this class on Wikipedia. This class is called Fluoroquinolones.
The list of damages this class causes is huge. Many of the most recently added side effects look, sound and feel like this drug may be one of the largest contributing factors of the recent epidemic of fibromyalgia. I do not know a single person who has not taken this drug. Its effects can be immediate but also build up. Once you reach a threshold, you will get ill. I, for example, have taken it for years without any problems and then suddenly I developed a tendon problem. That was 2 years ago. It took me this connection to realize that it was because of Cipro! There was no other reason for it: I casually walked our evening walk as usual, comfortably, no running, no jumping and bang. All of a sudden I had to limp home on tip toe. It took over a year to recover and I was lucky! It was my tendon and not my nervous system–so far at least!
I am providing you with links to literature that will take you further in reading and after the links I copy-paste here the side effects from Wikipedia so you know what to expect:
Side effects from Wikipedia:
In general, fluoroquinolones are well tolerated, with most side-effects being mild to moderate. On occasion, serious adverse effects occur. Common side-effects include gastrointestinal effects such as nausea, vomiting, and diarrhea, as well as headache and insomnia.
The overall rate of adverse events in patients treated with fluoroquinolones is roughly similar to that seen in patients treated with other antibiotic classes. A U.S. Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with cephalosporins or macrolides, but less frequently than those treated with penicillins, clindamycin, sulfonamides, or vancomycin.
Post-marketing surveillance has revealed a variety of relatively rare but serious adverse effects that are associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of “black box” warnings in the United States. Quinolones are associated with an increase risk of tendonitis and tendon rupture in all age groups. This side effect is most common but not limited to the Achilles tendon. Fluoroquinolone-associated tendinopathy symptoms have occurred as early as 2 hours after the initial fluoroquinolone exposure and as late as 6 months after the medication was discontinued. The most severe form of tendonopathy associated with fluoroquinolone administration is tendon rupture, which in the great majority of cases involves the Achilles tendon. Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients. The overall frequency of fluoroquinolone-associated Achilles tendon rupture in patients treated with ciprofloxacin or levofloxacin is has been estimated at 17 per 100,000 treatments (three times the rate in people without fluoroquinolone exposure). Risk is substantially elevated in the elderly and in those with recent exposure to topical or systemic corticosteroid therapy. Simultaneous use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture. Other risk factors include patients with kidney, heart and lung transplants, strenuous physical activity during or immediately after treatment, renal failure or previous tendon disorders like rheumatoid arthritis. Some experts have advised avoidance of fluoroquinolones in athletes.
Fluoroquinolones (FQs) prolong the heart’s QT interval by blocking voltage-gated potassium channels. Prolongation of the QT interval can lead to torsades de pointes, a life-threatening arrhythmia, but in practice this appears relatively uncommon in part because the most widely prescribed fluoroquinolones (ciprofloxacin and levofloxacin) only minimally prolong the QT interval.
Clostridium difficile-associated diarrhea may occur in connection with the use of any antibacterial drug, especially those with a broad spectrum of activity such as clindamycin, cephalosporins, and fluoroquinolones. Fluoroquinoline treatment is associated with risk that is similar to or less than that associated with broad spectrum cephalosporins. Fluoroquinoline administration may be associated with the acquisition and outgrowth of a particularly virulent Clostridium strain.
The U.S. prescribing information contains a warning regarding uncommon cases of peripheral neuropathy, which can be permanent. Other nervous system effects include insomnia, restlessness, and rarely, seizure, convulsions, and psychosis. Other rare and serious adverse events have been observed with varying degrees of evidence for causation.
Events that may occur in acute overdose are rare, and include renal failure and seizure. Susceptible groups of patients, such as children and the elderly, are at greater risk of adverse reactions during therapeutic use.
Quinolones are contraindicated if a patient has epilepsy, QT prolongation, pre-existing CNS lesions, or CNS inflammation, or the patient has suffered a stroke. They are best avoided in the athlete population. There are safety concerns of fluoroquinolone use during pregnancy and, as a result, are contraindicated except for when no other safe alternative antibiotic exists. However, one meta-analysis looking at the outcome of pregnancies involving Quinolone use in the first trimester found no increased risk of malformations. They are also contraindicated in children due to the risks of damage to the musculoskeletal system. Their use in children is not absolutely contraindicated, however. For certain severe infections where other antibiotics are not an option, their use can be justified. Quinolones should also not be given to people with a known hypersensitivity to the drug.”
As you can see, this is not a drug to be taken lightly. In fact it has a 43-page long warning that is supposed to be included in the box when you get this medicine but as many times as I have taken it, I never ever received the black box warning. You can find the 43-page warning here.
So next time you have a bacterial infection, I recommend you print this page out and many of the pages at the links and if you wish the 43-page warning and show your doctor. Demand an alternate medication. Furthermore, since the drug actively interferes with the voltage gated potassium channels, migraine sufferers will likely end up with migraine and in general everyone taking it will be dehydrated.
Your comments and questions are welcomed!