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FDA requests "black box" warning on Cipro and related antibiotics

By July 15, 2008

On July 8, 2008, the U.S. Food and Drug Administration (FDA) announced it is notifying the makers of fluoroquinolone antimicrobial drugs of the need to add a boxed warning to the prescribing information for pills, tablets, capsules and injectable forms (doesn't apply to eye or ear drops). The drugs included are: The strong warning on the label, often called a "black box" warning, is about the increased risk of developing tendinitis and tendon rupture when people take these drugs. Besides adding the warning, the drug manufacturers are required to develop a Medication Guide for patients explaining the risks of taking these antibiotics.

The risk of developing tendon problems when taking these drugs is increased in those over age 60, in kidney, heart, and lung transplant recipients, and when taken along with corticosteroids like prednisone. Doctors 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 drug.

Comments
July 17, 2008 at 11:09 am
(1) ciprovictimalso says:

Miss Mary,

I have a question. Does the following statement “The risk of developing tendon problems when taking these drugs is increased in those over age 60″ imply that most tendon ruptures reported were those over 60 therefore people over 60 need to be more aware of these adverse reactions than those younger?

November 22, 2008 at 11:58 am
(2) donttake it says:

Don’t let this statement (or the FDA) mislead you… this is a powerful antibiotic no matter what your age. Don’t take it!! I only took it for 8 days and suffered knee damage.

There is a whole “political history” on why this drug was developed (and now overprescribed).. do some research and you’re eyes will be opened.

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