The U.S Food
and Drug Administration (FDA) has warned against the routine use of fluoroquinolones
antibacterial drugs in clinical practice for uncomplicated urinary tract
infections and other respiratory infections. These group of drugs outweigh the
benefits to patients due to potential serious side effects. FDA advises the use
of these drugs only if other options are not available.
A recent FDA
safety review has shown that fluoroquinolones when used systemically (i.e.
tablets, capsules, and injectable) are associated with disabling and
potentially permanent serious side effects involving the tendons, muscles,
joints, nerves, and central nervous system. These can occur together or can
affect isolated system.The common
side effects of the fluoroquinolones are gastrointestinal disturbances,
headaches, skin rash and allergic reactions. Less common but more severe
side effects include QT prolongation, seizures, hallucinations, tendon rupture,
angioedema and photosensitivity.
FDA is
requiring labelling change with updated boxed warning stating that they should
only be used if no other treatment option is available for uncomplicated
urinary tract infections, acute sinusitis and bronchitis.
The fluoroquinolones
currently approved by FDA for systemic use are Moxifloxacin, Ciprofloxacin, Ciprofloxacin extended-release, Gemifloxacin, Levofloxacin,
Ofloxacin and moxifloxacin injection.
FDA has
asked patients to contact health care providers immediately if any of these
symptoms occur while taking the drugs. Some signs and symptoms of serious side
effects include tendon, joint and muscle pain, a “pins and needles” tingling or
pricking sensation, confusion, and hallucinations.
Physicians
and other health care providers should stop using systemic fluoroquinolones if
patient reports any of the side effects and should immediately switch to other
group of drugs to complete the treatment.
References:
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