Saturday, 31 August 2013

Ciprofloxacin: The Antibiotic With A High Risk Of Neuropathy

Today's post from forbes.com talks about the risk of side effects from Fluoroquinolone antibiotics specifically in this case, Ciproxin (ciprofloxacin). Neurotoxicity and the worsening of neuropathic symptoms is already a well-known possible side effect of these drugs but as they increasingly become the antibiotic of choice for more and more doctors, the potential for side effects can be overlooked. It's important then to arm yourself with knowledge and always check the labels, drug interactions and possible side effects of any new drug you may be prescribed - your doctor may just not have the time. After that, your doctor won't object if you wish to discuss it further.


Antibiotic Alert: The Drug The Doctor Ordered Could Cause Deadly Side Effects
Melanie Haiken, Contributor 9/30/2012 


One of Many Educational Campaign Alerts Warning of Quinolone Reactions


A couple of months ago I took my teenage daughter to the doctor for an ear infection, and came home with a prescription for the antibiotic Cipro. I’ve taken it before myself, and thought nothing more about it – until I read the fine print in the insert that said it wasn’t recommended for patients under 18. That made me call the advice nurse, who assured me there was nothing to worry about. It also made me dig a little deeper, and start asking questions.

And then a couple of weeks ago the New York Times came out with a scary blog post about Cipro and related antibiotics, and I really began to wonder.

The Frightening History of Fluoroquinolones

Some of this isn’t news, exactly. (Except that the message doesn’t seem to be getting through.) For at least 15 years, patients, doctors and pharmacology experts have been warning about the dangerous and potentially deadly side effects of fluroroquinolones, often referred to as quinolones or FLQs in the health field.

Fluoroquinolones are extremely powerful antibiotics, developed to treat serious respiratory tract infections such as hospital-induced pneumonia, and other antibiotic-resistant or potentially deadly infections. (Cipro received major press when it was prescribed to postal workers and soldiers to prevent anthrax infection.)

Infectious disease experts consider them to be an antibiotic of last resort, to be prescribed only when first-line antibiotics such as penicillin fail to work, or in cases of extreme, life-threatening infection, or for certain bacteria known to respond best to quinolones. However, many doctors now go to Cipro and Levaquel first, prescribing them for ear infections, sinus infections, urinary tract infections, and many other common bacterial diseases.

The most common American antibiotics in this class are Cipro (Bayer). Levaquin (Johnson; Johnson), and Avelox (Bayer) – generics are ciprofloxacin, levofloxacin, and moxifloxacin, and others with the word “flox” in them. Lots of antibiotics have side effects, but what makes quinolones so much riskier is that the side effects caused aren’t necessarily temporary; they can cause severe and permanent disability.

Just a few listed on the drugs’ warning labels or named in studies:

Toxic Psychosis
Neuropathy
Retinal Detachment
Tendon Rupture
Muscle Damage
Seizures
Heart Arryhthmias
Abnormal Liver Function
Kidney Damage

Neurotoxicity was one of the first side effects reported. As far back as 2001, Indiana University Professor David Flockhart, considered one of the foremost experts in fluoroquinolone-related side effects, published research linking quinolones to neurotoxicity.

Flockhart also had this to say: “…as many as a third of patients taking a fluoroquinolone will experience some sort of psychiatric side effect, such as anxiety, personality change or confusion…The psychiatric effects of the fluoroquinolones are underappreciated by the medical profession as well as by the public.”

Also in 2001 Jay Cox of the University of California, San Diego, published research demonstrating the potential of fluoroquinolones to cause peripheral neuropathy. Since then, Cox since then has been documenting “terrible, catastrophic reactions” to Cipro, Levaquin and other drugs in the class in a newsletter.

Even earlier, in his 1998 book Bitter Pill, journalist Stephen Fried documented his wife’s reaction to Floxin, one of the earliest of the quinolones (now pulled from the market), and his family’s journey to get her condition recognized and treated.

The most recent researched, published in the Journal of the American Medical Association in April, linked fluoroquinolones to retinal detachment, which can cause temporary or permanent blindness.

Cipro and Levaquin now carry “black box” warnings for tendon rupture and for the potential to exacerbate the autoimmune condition myasthenia gravis.

The Numbers

The statistics on adverse reactions to Cipro, Levaquin and others aren’t considered complete because of the way the FDA’s database is constructed; the FDA considers its system to reflect about 10 percent of the actual incidence. Even so, there have been 2,500 documented deaths resulting from the major quinolones and 45,000 cases of side effects. Websites like Hurt by Levaquin and Surviving Cipro have sprung up as forums for those who consider themselves victims of the drugs.

The Business Side

Even with generics on the market, Levaquin is still one of Johnson & Johnson’s top sellers; Levaquin sales were 1.5 billion in 2010. However, J&J faces a mounting pile of lawsuits filed by those who believe they were injured by the drug. The drug-maker has strengthened warnings about Levaquin’s dangers multiple times since the medication gained approval in 1996, and continues to stand by the drug’s safety.

Here is the quote I received from Shaun Mickus, Director of Product Communication for Janssen Pharmaceuticals, which owns Johnson & Johnson: “LEVAQUIN is part of an important class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. When used according to the product labeling, LEVAQUIN has been proven to be a safe and effective medication.”

In January 2012, Harrington Investments of California submitted a shareholder’s proposal to J&J management asking the company to make changes to address the health and financial concerns of patients harmed by the drug.

“When something generates this much litigation and this much negative attention maybe it’s time to take a look at whether the product is worth the hassle—and the expense,” Jack Ucciferri, the director of research for the investment firm, was quoted as saying. “We were appalled at the number of lawsuits.”

An Even More Frightening Future?

What never seems to be clearly explained in consumer health stories or the medical literature is why it’s been so hard to control the frequency with which Cipro, Levaquin, and other quinolones are prescribed. Or why they are so often prescribed for infections that could be cured with less risky antibiotics. One of the most recent studies found that in hospitals alone, 39 percent of fluoroquinolone prescriptions were unnecessary.

In 2011, despite protests from consumer groups, the FDA approved the first generic versions of Levaquin, or levofloxacin, making the drug much less expensive to prescribe.

As patents expire, pharmaceutical companies are continuing to modify the chemical structure of fluoroquinolones in search of similar, effective antibiotics to patent. Some experts have expressed concern that the newest generation of such drugs, judging from their chemical structures, are even more likely to cause adverse side-effects than are now-popular ones like Cipro and Levaquin.

As always when I report on drugs and pharmaceutical companies, opinions are bound to be strong, and comments are welcome; however flaming won’t be tolerated.

http://www.forbes.com/sites/melaniehaiken/2012/09/30/antibiotic-alert-the-drug-the-doctor-ordered-could-cause-deadly-side-effects/

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