Monday, May 30, 2016

FDA warns to limit systemic use of fluoroquinolones antibacterial drugs.

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.

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