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2008: FDA Warning: Cipro May Rupture Tendons


Agency Issues 'Black Box' Warning for Antibiotics Known as Fluroquinolones
By Todd Zwillich
From the WebMD Archives


July 8, 2008 -- Federal regulators are ordering new warnings on Cipro and similar antibioticsbecause of increased risk oftendinitis and tendon rupture.


FDA advises restricting fluoroquinolone

FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued July 26, 2016


WARNING: SERIOUS ADVERSE REACTIONS

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

See full prescribing information for complete boxed warning.

RECENT MAJOR CHANGES

Boxed Warning 7/2016

Indications and Usage (1.1) 7/2016

Warnings and Precautions (5.1) 7/2016


This drug can kill you.

Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug .

Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of CIPRO by as much as 90%

Disabling And Potentially Irreversible Serious Adverse Reactions Including Tendinitis And Tendon Rupture, Peripheral Neuropathy, And Central Nervous System Effects

Fluoroquinolones, including CIPRO XR, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting CIPRO XR. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Fluoroquinolones, including CIPRO XR, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis. CIPRO XR may also cause central nervous system (CNS) events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions that have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide. These reactions may occur following the first dose.