Warnings about fluoroquinolone
January 3, 2009
FDA ALERT [7/8/2008]: FDA is notifying the makers of fluoroquinolone antimicrobial
drugs for systemic use of the need to add a boxed warning to the prescribing
information about the increased risk of developing tendinitis and tendon rupture in
patients taking fluoroquinolones and to develop a Medication Guide for patients. The
addition of a boxed warning and a Medication Guide would strengthen the existing
warning information already included in the prescribing information for
fluoroquinolone drugs.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon
rupture. This risk is further increased in those over age 60, in kidney, heart, and
lung transplant recipients, and with use of concomitant steroid therapy. Physicians
should advise patients, at the first sign of tendon pain, swelling, or inflammation, to
stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and
to promptly contact their doctor about changing to a non-fluoroquinolone
antimicrobial drug.

Selection of a fluoroquinolone for the treatment or prevention of an infection should
be limited to those conditions that are proven or strongly suspected to be caused
by bacteria.
Regarding Fluoroquinolones:

FDA is notifying the makers of fluoroquinolone antimicrobial drugs of the need to add a
Boxed Warning to the prescribing information about the increased risk of tendinitis and
tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for
patients.*  Fluoroquinolone antimicrobial drugs are used to treat various bacterial
infections.  Marketed fluoroquinolone antimicrobial drugs include
ciprofloxacin (marketed
as
Cipro and generic ciprofloxacin), ciprofloxacin extended release (Cipro XR and Proquin
XR
), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin),
moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin
(marketed as
Floxin and generic ofloxacin).

The information regarding warnings for fluoroquinolones and adverse effects on tendons
applies to fluoroquinolones for systemic use (e.g., tablets, capsules and injectable
formulations); it does not apply to fluoroquinolones for ophthalmic or otic use (e.g., eye
drops and ear drops).

Recommendations and Information for Healthcare Professionals to Consider Regarding
Fluoroquinolones:

* Fluoroquinolones are associated with an increased risk of tendinitis and tendon
rupture.
 This risk is further increased in those over age 60, those on concomitant steroid
therapy, as well as in kidney, heart, and lung transplant recipients.  The fluoroquinolone
should be discontinued if the patient experiences pain or inflammation in a tendon
(symptoms that may precede rupture of the tendon), or tendon rupture. Advise patients, at
the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to
avoid exercise and use of the affected area, and to promptly contact their healthcare
provider about changing to a non-fluoroquinolone antimicrobial drug.

* Healthcare professionals should consider the potential benefit and risks to each
individual patient before prescribing a fluoroquinolone antimicrobial.
While most patients
prescribed fluoroquinolones tolerate these medicines, rarely patients develop serious
adverse reactions which may include convulsions, hallucinations, depression, QTc
prolongation and torsade de pointes, or Clostridium difficile associated diarrhea.  Rarely,
damage to the liver, kidneys or bone marrow, or alterations in glucose homeostasis may
occur.

* Fluoroquinolones should only be used for the treatment or prevention of infections that
are proven or strongly suspected to be caused by bacteria.  
Fluoroquinolones, like other
antibacterial drugs, do not treat viral infections such as the common cold or influenza.   

Information for Healthcare Professionals to Provide When Counseling Patients:

* Tendon rupture

o Pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand,
or other tendons can happen in patients taking fluoroquinolone antibiotics.  Tendons are
the areas that connect your muscles to your joints. The Achilles tendon is at the back of the
ankle.  The chance of getting tendon problems is higher if you are:
+ over 60 years of age
+ taking steroids (corticosteroids)
+ a kidney, heart, or lung transplant recipient

o Other reasons for tendon ruptures include:
+ physical activity or exercise
+ kidney failure
+ tendon problems in the past, such as with rheumatoid arthritis

o Call your healthcare provider right away at the first signs or symptoms of pain, swelling or
inflammation in a tendon area.  These could be symptoms of tendinitis or tendon rupture.  
Stop taking your fluoroquinolone until a healthcare provider has determined that you do not
have tendinitis or a tendon rupture.  Signs or symptoms of tendon rupture include:
+ a snap or pop in a tendon area
+ bruising right after an injury in a tendon area
+ inability to move the affected area or bear weight

o At the first sign of pain, swelling, or inflammation in a tendon area, avoid exercise and
use of the affected area.

o Talk to your healthcare provider about the risk of tendon rupture with continued use of a
fluoroquinolone and whether you should be prescribed a different type of antibiotic to treat
your infection.

* Tell your doctor about other medicines that you take and other medical conditions that you
have.  Some medicines may interact with a fluoroquinolone and cause serious side
effects.  Also, some medical conditions may make you more likely to have a serious side
effect when you take a fluoroquinolone.

* Fluoroquinolones, like any drug, have possible side effects associated with their use.  
Rarely, some side effects may be serious or even fatal; however, most of the risks are
mild.  Some of the most serious side effects include seizures, hallucinations, depression,
heart rhythm changes (QTc prolongation and torsade de points), and intestine infection
with diarrhea.  Rarely, damage to the liver, kidneys or bone marrow, and changes to blood
sugar may occur.

* Fluoroquinolones are antimicrobials that are effective in treating infections caused by
certain bacteria.  They do not help to treat infections caused by viruses, such as a common
cold or the flu.

Background Information

A warning about the increased risk of tendinitis and tendon rupture in patients taking
fluoroquinolones was previously added to the prescribing information for
fluoroquinolones.  However, FDA’s recent evaluation of the medical literature and the post-
marketing adverse event reports submitted to the Adverse Events Reporting System
(AERS) confirmed that serious reports of tendinitis and tendon rupture with the
fluoroquinolones continue to be reported in similar or increased numbers.

Tendinitis and tendon rupture most frequently involves the Achilles tendon, and rupture of
the Achilles tendon may require surgical repair.  Tendinitis and tendon rupture in the rotator
cuff (the shoulder), the hand, the biceps, and the thumb have also been reported.  The risk
of developing fluoroquinolone-associated tendinitis and tendon rupture is especially
increased in patients over 60 years, in those concomitantly taking corticosteroid drugs, and
in patients with kidney, heart or lung transplants. Tendon rupture can occur during or after
completion of fluoroquinolone use; cases occurring up to several months after completion
of therapy have been reported.

Tendon rupture is a serious adverse event that could potentially be prevented or reduced in
frequency or severity by appropriate use of a fluoroquinolone, patient selection, and careful
monitoring.  Therefore, FDA is notifying the makers of the fluoroquinolones of the need to
add a Boxed Warning to the prescribing information for fluoroquinolones to highlight and
strengthen the existing warning about the increased risk of fluoroquinolone-associated
tendinitis and tendon rupture.  FDA is also notifying the makers of fluoroquinolones of the
need to develop and distribute a Medication Guide to alert patients about these possible
side effects.

This article is for your information only. It is not a medical advice. Please, consult with your doctor
for details. All rights reserved 2009
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