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
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:
