Ciprofloxacin (Cipro XR, IV) Linked to Pseudomembranous Colitis, Peripheral Neuropathy, and Tendon Effects</p>
<p>On July 14, the FDA approved changes to the safety labeling for ciprofloxacin HCl extended release tablets and intravenous infusion (Cipro XR and Cipro IV, made by Bayer Pharmaceuticals), warning of the risks of pseudomembranous colitis, peripheral neuropathy and tendon effects associated with their use.</p>
<p>The FDA recommends that therapeutic measures be initiated after a diagnosis of pseudomembranous colitis in patients receiving ciprofloxacin. Mild cases usually respond to drug discontinuation alone, while management of moderate to severe cases should include fluids and electrolytes, protein supplementation, and treatment with an antibiotic clinically effective against Clostridium difficile colitis. Drugs that inhibit peristalsis should be avoided.</p>
<p>Rare postmarketing reports have been received by the FDA of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons and resulting in paresthesias, hypoesthesias, dysesthesias, and weakness in patients receiving quinolone therapy.</p>
<p>Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness, or having deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength, in order to prevent the development of an irreversible condition.</p>
<p>Ruptures of the shoulder, hand, Achilles tendon, and other tendons resulting in prolonged disability or requiring surgical repair have also been reported in patients receiving quinolone therapy. According to the FDA, reports indicate a possible increased risk in patients receiving concomitant steroids, especially in the elderly.</p>
<p>The FDA advises that ciprofloxacin be discontinued in patients experiencing pain, inflammation, or tendon rupture. Patients should rest and refrain from exercise until tendonitis and tendon rupture have been excluded from the diagnosis.</p>
<p>Ciprofloxacin is a fluoroquinolone antibiotic indicated in the treatment of various infections caused by susceptible gram-negative and gram-positive bacterial strains in adults aged 18 years and older. It is also indicated for use in pediatric patients aged one to 18 years with complicated urinary tract infections and pyelonephritis. It is also indicated for adult and pediatric use in the treatment of postexposure inhalational anthrax.