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FDA To Seek Black-Box Warning On Cipro and Levaquin

Jul 8, 2008 | Parker Waichman LLP

The U.S. Food and Drug Administration (FDA) has announced that it will seek to add black box warnings about the risk of tendon rupture associated with Cipro and Levaquin.  The drugs are in a class of antibiotics used to treat bacterial infections and black box warnings are the strongest warning the FDA issues.  Cipro is made by Bayer AG and Johnson & Johnson makes Levaquin.  Six months ago, the consumer group Public Citizen sued the FDA to require it to add black-box warnings to the drugs.

Cipro and Levaquin belong to the antibiotic group known as fluoroquinolones, which are sold by several drug makers under a variety of brand and generic names.  Although the drug labels warn of the risk of tendon ruptures, none include black-box warnings.  A black-box warning is in bold type, surrounded by a black box to make it stand out. Such warnings usually appear at the top of drug labels.  Any advertising of products that carry black box labels must also include the black box warning information as part of the advertisement.  The FDA also announced it will ask the drug companies to create a Medication Guide to be provided to patients to alert them about possible side effects.

Serious reports of tendonitis and tendon rupture are on the rise with the use of these drugs, which finally prompted the FDA to ask drug companies to add the stronger labeling.  The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs.  Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle.  The risk of tendonitis and tendon rupture linked to drugs such as Cipro and Levaquin is "especially increased" in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.

Fluoroquinolone Antimicrobial Drugs include:  Cciprofloxacin, marketed as Cipro and generic ciprofloxacin; ciprofloxacin extended release, marketed as 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 FDA believes that the addition of a black box warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.

The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—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.”  Fluoroquinolone is only suggested for the treatment or prevention of an infection proven to be caused by, or strongly suspected to be caused by, bacteria.

According to the FDA release, other side effects experienced in those taking Fluoroquinolones 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.”


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