Fluoroquinolones: Boxed Warning to be added for risk of tendon rupture and tendinitis

2008-07-21

The U.S. Food and Drug Administration, the american counterpart to the Saudi Food and Drug Authority (SFDA), notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

This risk of tendinitis and tendon rupture is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Marketed fluoroquinolone antimicrobial drugs in Saudi Arabia include:

Generic Name	Trade Name ®	Generic Name	Trade Name ®
CIPROFLOXACIN	BACTALL CIFLOX CIPROBAY CIPROCIN Tab. CIPRODAR CIPROFLACIN CIPROFLOX CIPROGEN CIPROLET CIPROLON CIPROMAX Tab. CIPROMID CIPROPHARM CIPROQUIN CIPRO-SOL CIPROXEN EMICIPRO FLOXACIN OMACIP QUINOX SARF	LEVOFLOXACIN	TAVANIC I.V INFUSION TAVANIC FILM COATED Tab.
		MOXIFLOXACIN HYDROCHLORIDE	AVALOX
		NORFLOXACIN	NORACIN UROXIN Noroxin
		OFLOXACIN	NOVECIN OFLACIN TARIVID
		OFLOXACIN + DEXAMETHASONE	DEXAFLOX
		LOMEFLOXACIN	LOMAX OKACIN
		ENOXACIN	PENETREX

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. The fluoroquinolone should be discontinued if the patient experiences inflammation in tendon. Advise patients, at the first sign of tendon inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of affected area, and to 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.

Fluoroquinolones should only be used for the treatment or prevention of infections that are proven or strongly suspected to be caused by bacteria. It doesn’t treat viral infections.

Information for Patients to consider regarding Fluoroquinolones :

Call your healthcare provider right away at the first signs or symptoms inflammation in a tendon area. Stop taking your fluoroquinolone until a healthcare provider has determined that you do not have 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 inflammation in a tendon area, avoid exercise and use of the affected area.

Tell your doctor about other medicines that you take and other medical conditions that you have.

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

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.

Report Adverse Dug Reaction to the SFDA:

The public and health care professionals are strongly encouraged to report adverse drug reaction to the National Pharmacovigilance Center (NPC) by filling the appropriate form on the following link: