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FluoroquinolonesOn July 8th of 2008, the FDA notified 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:
- 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
- Other reasons for tendon ruptures include:
- physical activity or exercise
- kidney failure
- tendon problems in the past, such as with rheumatoid arthritis
- 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
- At the first sign of pain, swelling, or inflammation in a tendon area, avoid exercise and use of the affected area.
- 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.
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