Levaquin Blog

Zark from www.ZarkAnderson.com posted the following piece.  It has some great advice for both potential Levaquin users and prescribers.

Yesterday my younger son called from college, telling the doctor had just prescribed Levaquin for some bug that he has been unable to shake.  We immediately advised him to return and request a completely different antibiotic.

Wiki tells that levofloxacin is a chemotherapeutic drug used to treat bacterial infections.  More specifically, it is a fluoroquinolone antibiotic with sister drugs such as Noroxin and Cipro.  This family of drugs kills bacteria by interfering with DNA replication.  Other families of antibiotics such as penicillins and cephalosporins attack other structures of the bacteria instead of inhibiting DNA replication.

Sounds like a sophisicated antibiotic doesn’t it?  However, Wiki tells us in Adverse effects of fluoroquinolones there are adverse drug reactions in 5 to 16 percent of patients.  Although rarer, there are serious adverse effects such as central nervous system (CNS) toxicity and tendon toxicity.  FDA orders ‘black box’ label on some antibiotics tells that in July 2008, the FDA ordered manufacturers to warn patients about possible tendon ruptures and tendonitis.  In the CNN article, the FDA stated it had received ‘hundreds’ of reports of tendon problems correlated to fluoroquinolones.

Almost one month prior to the FDA action, I took Levaquin for an infection.  I had only taken two pills and while running on that second day was stricken with tendonitis in my quadriceps and hamstrings so badly that I could barely make it home.  Later the tendonitis became much more widespread.  I am not exaggerating – it was scary.  To read some of the horror stories of other patients, see The Flouroquinolone Syndrome.

It is important to understand the potential adverse reactions to these antibiotics is not an upset stomach or rash, but a real risk of tendon ruptures and other damage.  After about six months of exercising in a pool, the tendonitis subsided and I was able to resume running.  And I only took two pills.

It is not my intent to bash the pharmaceutical companies – we need new and better medicines all the time.  But after my son innocently received a prescription for Levaquin, I decided I should issue a personal warning about these antibiotics.  There is a reason that the FDA has issued a black box warning.

Physicians – do not prescribe them unless it is a life-or-death situation.  Prescribe another antibiotic.

Patients – Likewise, if you receive a script for Levaquin, ask for something different.

Source: http://www.zarkanderson.com/2009/10/caution-about-levaquin.html

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Here is a thoughtful piece from John Fratti of Levaquin Adverse Effects Blog. If you have any questions for John, his email address appears below.

Quinolones are currently one of the most commonly prescribed classes of antiobiotics. They are very powerful medications used to treat many types of infections such as respiratory infections, urinary tract infections, and sinus infections. The two most commonly prescribed quinolones are Levaquin and Cipro. Like all medications this class of antibiotics has side effects. However, what differentiates this class of antibiotics from others is that quinolones have the ability to cause severe and permanent disability. Many of these side effects can even occur weeks to months after taking the antibiotic. Approximately half of the quinolones that were once on the market have now been removed from clinical practice due to their severe toxicities. Examples include Tequin, Omniflox, Trovan, and Zagam. The package insert for all quinolone antibiotics lists irreversible pain and irreversible neurological damage as possible side effects.

There is no question that quinolone antibiotics have their usefulness. They are extremely powerful medications that work very well to kill difficult to treat infections. They have proved to be life saving in certain situations. However, they were never meant to be used as a first line of defense against mild infections which is how they are often prescribed today.

In July of 2008, the FDA mandated that all quinolone antibiotics carry a “Black Box “ warning for tendon rupture and tendonitis. This is the strongest warning label a drug can have before it is removed from the market. Public Citizen, a consumer advocacy group, sued the FDA demanding quinolones carry a Black Box warning. If Public Citizen had not taken this action there may not be any “Black Box” warning for this class of antibiotics. The FDA gets approximately 50% of their funding directly from the pharmaceutical companies in what is called prescription drug user fees. This is an absurd conflict of interest that has made the FDA very slow and often reluctant to react to drug toxicities of all kinds. What the FDA is doing and what the public thinks the FDA is doing is as different as night and day- A quote from Dr. Herbert Ley, former commissioner of the FDA. If you look closely at the track record of the FDA it would indicate that they are serving interests other than yours and mine. In 2007, China executed Zheng Xiaoyu, who was the head of the food and drug administration in that country for taking $800,000 of money from the drug companies. In America, this behavior seems to be simply business as usual.

Dr. David Graham, from the FDA, says that the Vioxx debacle alone caused more than 60,000 deaths. To put that in perspective, that is more deaths than the number of American troops that died in the Vietnam war. Since the major media outlets obtain considerable advertising revenue from the drug industry they are often reluctant to do a story on the damaging side effects of medications. They don’t like to bite the hand that feeds them.

Unfortunately, the Black Box warning is far too late for the thousands of people that are now living with devastating disabilities. Lariam, a quinolone derivative, that is used strictly for malaria prevention has been widely prescribed to US troops since the 1990’s. An award winning documentary titled “Taken as Directed“ details the extensive physical and neurological damage caused by Lariam. 60 Minutes and Consumer Reports magazine also did a story on Lariam toxicity. Some of the many websites that describe the severe adverse reactions to quinolones include: Antibiotics.org, Favc.info, Fqvictims.org, Fqresearch.org, and Lariaminfo.org

Dr. Jay Cohen, a medical researcher and associate professor at the University of California, San Diego published a paper on severe peripheral neuropathy caused by quinolones. Dr. Cohen mentions that these debilitating reactions are not rare. He mentions that most doctors have dismissed patient complaints or outright deny that quinolones can cause this type of long term damage even though it is mentioned in the package insert. Even if one person in 100 suffers a grave side effect that can still mean millions of people affected. Even the FDA admits that less than 5 % of all adverse drug reactions ever get reported to their agency.

David Flockhart, professor of medicine and chief of clinical pharmacology at Indiana University School of Medicine, says as many as a third of patients taking a quinolone will experience some sort of psychiatric side effect, such as anxiety, personality change, or confusion. “ The psychiatric effects of the quinolones are underappreciated by the medical profession as well as by the public,” says Dr. Flockhart, who has treated more than one hundred patients with severe psychiatric side effects.

Before anyone takes this class of antibiotics they should have the right to know that it can cause irreversible damage. People need to be afforded the right of informed consent. The prescribing literature patients receive at the pharmacy is far different than what is in the tiny print in the package insert. Why am I writing an article on quinolone antibiotics? I feel that I have a moral obligation to warn as many people as possible. I was a pharmaceutical sales representative who was in great health and led a very clean life. I worked hard to obtain a master’s degree and I loved my job. Over three and a half years ago I was prescribed a handful of Levaquin pills for a possible infection and like tens of thousands of others my life has been turned into a living hell. I write this article in the hopes of preventing others from suffering a similar fate.

Jfratti@comcast.net
www.Levaquinadversesideeffect.com

Source: http://www.levaquinadversesideeffect.com/?page_id=2

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Five Illinois residents have filed suit against Johnson and Johnson, Ortho-McNeil Pharmaceutical, Johnson and Johnson Pharmaceutical Research and Development and Walgreens after they say an antibiotic caused them severe tendon problems.

Plaintiffs Susan Price, Jerry Mahlandt, Johnna Woosley, David Force and Rachel Speiser say they took the antibiotic Levaquin, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.

What the plaintiffs claim they did not know at the time they took Levaquin is that it causes a higher incidence of tendon injuries, including tendon rupture, in people who are older than 60 or who are on corticosteroid therapy, according to the complaint filed Sept. 2 in St. Clair County Circuit Court.

“Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries,” the suit states.

As a result of their taking the antibiotic, all the plaintiffs say they suffered severe and permanent tendon injuries.

Levaquin is part of a class of antibiotics known as fluoroquinolones and was originally introduced into the U.S. in 1997, the complaint says.

When Levaquin entered the market, warnings about tendon side effects were required on all fluoroquinolone labels, but were buried in a long list of potential adverse reactions, the plaintiffs claim. In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaint.

In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suit states.

“More disturbingly, Defendants’ promotional campaign was themed on Levaquin’s excellent safety profile and failed to disclose the risks of tendon injury,” the complaint says.

After world-wide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic, the plaintiffs claim. However, the new warning only included information about the risks to people who were on corticosteroid therapy and contained no warnings about risks to the elderly, according to the complaint.

“Accordingly, despite the 2002 label change, Levaquin prescriptions only increased and tendon injuries mounted,” the suit states.

Other European countries began discussing the requirement of heightened label change as early as 2001, and collaborated with Johnson and Johnson PRD to perform a study on the antibiotic’s effects, the complaint says.

The plaintiffs claim that Johnson and Johnson PRD, however, only analyzed achilles tendon ruptures in its study and did not assess the risk of Levaquin tendon toxicity. In addition, Johnson and Johnson PRD created an algorithm that excluded nearly 70 percent of health claims for the elderly who suffered Achilles tendon rupture, according to the complaint.

“The algorithm used CPT procedure codes that only related to surgical repair,” the suit states. “This algorithm thereby excluded all those Achilles tendon rupture cases where the patient was casted or booted, as is the case in the elderly population. By manipulating the data, Defendant Johnson and Johnson PRD was able to exclude the very group that was prone to tendon rupture.”

As a result, the Johnson and Johnson PRD study found no increased risk of achilles tendon rupture and found neither age nor corticosteroid use altered the findings, the complaint says.

As a result, the Levaquin label was not changed as had been recommended.

Because the defendants issued no warnings to doctors, physicians continued to prescribe the antibiotic, the plaintiffs claim.

However, Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaint.

Injuries continued to soar as Levaquin’s popularity increased, the suit states.

Even the Illinois attorney general took notice and in 2005 submitted a petition to the FDA requesting that a black box warning be placed on the antibiotic’s label, the complaint says.

Although the black box warning was not been placed on Levaquin’s packaging, a revised label was placed on the antibiotic in April 2007. However, the plaintiffs say the label continued to bury warning about tendon risks and did not contain a warning about Levaquin’s greater association with tendon toxicity as compared to other fluoroquinlones.

Finally, in July 2008, a revised Levaquin label contained a black box warning, but still fails to warn about its higher risk of tendon toxicity compared to other similar antibiotics, according to the complaint.

In the 10-count suit, the plaintiffs allege strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Illinois Consumer Fraud Act, unjust enrichment, breach of warranty and failure to warn.

Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin. Walgreens sold the plaintiffs the drug, the suit states.

The plaintiffs are seeking actual and compensatory damages, plus costs, pre- and post-judgment interest and other relief the court deems just.

By: Kelly Holleran

Source: www.madisonrecord.vom

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Here’s a story (and some advice) from Ball Quick Athletics concerning the special risks weightlifters face when prescribed Levaquin:

Antibiotics and Injuries: Which Class of Antibiotics Can Bring Your Lifting Career to a Screeching Halt?

It’s almost that time of the year. Football season is just beginning, my lawnmower is getting less and less use, and the temperature is fluctuating more than the stock market. And the season wouldn’t be complete without an endless stream of antibiotics coming from the doctors’ offices. But before you go begging your doctor for an antibiotic for that runny nose, there’s one class of antibiotics that you better be particularly concerned about, especially if you lift heavy weights.

And that class is…. Fluoroquinolones (i.e. Cipro, Levaquin,etc)

Introduced in the 1980s, this class antibiotics is becoming increasingly popular with each passing year primarily due to the increase in antibiotic-resistant infections. Used most commonly to treat pneumonia and bronchitis, nowadays doctors are using them to treat just about everything. In fact at my pharmacy, they’re quickly creeping up the list of most popular antibiotics dispensed, right behind amoxicillin, azithromycin, and bactrim ds.

And why should you care… Tendon ruptures (those things that connect your bones to your muscles)

99 out of 100 doctors aren’t going to ask you if you lift weights. In fact, 99 out of 100 doctors are probably going to tell you squatting 300 pounds is extremely dangerous:-) So it’s your responsibility to be aware of potential tendon problems associated with fluoroquinolone use.

Even though they’re rare (most experts agree the odds are probably 1 in 100,000), the results can be extremely devastating, especially to an athlete or weekend warrior. In fact, in 2008 the FDA required that all fluoroquinolones carry a black box warning indicating potential tendon problems associated with their use (the equivalent of wearing the scarlet letter). And what is even more concerning to you and I, we’re already at a higher risk because a potential risk factor for tendon rupture is participation in sports, which includes weightlifting. In addition, you’re even further at risk if you’re taking corticosteroids like prednisone. Even inhaled corticosteroids for allergies (Nasonex, Flonase, Nasacort) put you at a higher risk.

Another important fact: Just because you finished your 10 day course of Cipro without any pain, don’t think you’re out of the woods just yet. There’s been documented cases of tendon ruptures 6 months AFTER using a flouroquinolone.

How will you know? Snap, crackle, pop.

The most commonly affected tendon is the Achilles tendon. However, they can affected virtually any tendon in your body. Symptoms range from stiffness and redness surrounding the tendon to complete inability to move the affected joint. Usually the pain is quick and intense.

I saw firsthand what Levaquin can do. My mother began a 5 day course of Levaquin, and had to stop after 3 days because of the tendon pain. It was so bad she couldn’t even walk up and down the stairs. And the worst part: it took 3 weeks for the pain to subside. And this is a lady who has passed 2 kidney stones without any pain medication stronger than Tylenol.

So what’s your options? Ask

Ask for a different antibiotic. Tell the doctor you lift weights, and you don’t want to risk injury. If you have pneumonia and are relatively healthy, ask for a z-pack. It’s considered first line anyways (plus it’s also a lot cheaper). With antibiotics, there is usually always alternatives. With so many of them out today, there’s almost always overlapping coverage for different types of bacterial infections, unless of course you have something truly funky going on.

More questions?

Here’s the best review I’ve found regarding fluoroquinolone-induced tendon ruptures: “Fluoroquinolone-associated tendinopathy: a critical review of the literature.”

Source: http://ballquickathletics.com/blog/?p=204

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What is an Achilles tendon rupture?

By Jonathan Cluett, M.D.

An Achilles tendon rupture occurs when the tendon attaching the calf muscle to the heel is ruptured. This is a common injury, most often seen in middle-age, male, “weekend warriors.”

What are the symptoms of an Achilles tendon rupture?

An Achilles tendon rupture is a traumatic injury that causes sudden pain behind the ankle. Patients may hear a ‘pop’ or a ’snap,’ and will almost always say they feel as though they have been kicked in the heel (even though no one has kicked them). Patients have difficulty pointing their toes downward, and may have swelling and bruising around the tendon.

Which patients sustain Achilles tendon ruptures?

Achilles tendon ruptures are most commonly seen in men who are around the age of 30-40 years old. About 15-20% of patients have symptoms of Achilles tendonitis prior to sustaining an Achilles tendon rupture, but the vast majority of patients have no history of prior Achilles tendon problems. Over 75% of Achilles tendon ruptures are associated with playing ball sports (commonly basketball or tennis).

Other risk factors that are associated with Achilles tendon rupture include:

Cortisone injections into the tendon
Gout
Fluoroquinolone antibiotic use
Fluoroquinolone antibiotics are used very commonly in medicine for treatment of respiratory infections, urinary tract infections, and other bacterial infections.

These antibiotics, such as Cipro, Levaquin, and others, are associated with Achilles tendon rupture. Exactly why this is the case is unclear, but patients on these medications should consider an alternative medication if Achilles tendon pain develops.

What is the treatment for Achilles tendon rupture?

Achilles tendon rupture is most often treated surgically to reattach the tendon to its normal position.

Nonoperative management can be undertaken, generally people who live sedentary lifestyles or who may have problems with wound healing. Nonsurgical treatment of an Achilles tendon rupture is accomplished by casting the Achilles tendon for several months. In these patients, the number of reruptures is higher compared to those patients who have surgical repair. In patients who have surgery for an Achilles tendon rupture, less than 3% experience a rerupture of the tendon.

How is surgery done for treatment of an Achilles tendon rupture?

The surgery to treat an Achilles tendon rupture involves an incision along the back of the ankle. Usually the incision is made just to the side of midline so shoes will not rub on the site of the scar. The torn ends of the Achilles tendon are identified and strong sutures are placed in both ends of the tendon. These strong sutures are then tied together to repair the tendon.

What are the complications of Achilles tendon repair?

The most common and worrisome complications following an Achilles tendon repair are problems with wound healing. The skin over the Achilles tendon sometimes does not heal well. Therefore, careful wound management is of utmost important following surgical repair of an Achilles tendon rupture. Other potential problems include infection, ankle stiffness, and rerupture of the tendon.

What is the rehab following Achilles tendon repair?

Rehabilitation following Achilles tendon repair is a controversial topic. Traditionally, patients were casted after surgery for a period of 4 to 8 weeks and after that time, patients were allowed to gently move the ankle.

More recently, studies have shown that patients do well and heal faster with more rapid mobilization. If a solid repair is attainable, patients may not be casted at all, and allowed to begin motion immediately after surgery. These patients will use a removable boot when walking for several weeks.

Sources:
www.about.com
Saltzman CL, Tearse DS. “Achilles tendon injuries” J. Am. Acad. Ortho. Surg., Sep 1998; 6: 316 – 325.
Schepsis, AA, et al. “Achilles Tendon Disorders in Athletes” Am. J. Sports Med., March 1, 2002; 30(2): 287 – 305.
Peck, P. “Study Confirms Increased Risk of Achilles Tendon Rupture With Fluoroquinolone Use” IDSA 41st Annual Meeting: Poster 195. Presented Oct. 10, 2003.

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