The FDA approved a revision on March 26 to the warnings and precautions sections of labeling for zafirlukast (Accolate, made by AstraZeneca) describing the associated risk of hepatotoxicity.

Cases of life-threatening hepatic failure have been reported to the FDA. Patients should be advised to be alert for signs and symptoms of liver dysfunction such as right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia. Patients should contact their physician immediately if these occur, the FDA advised.

The FDA approved revisions on March 25 to the precautions and adverse reactions sections of labeling for ciprofloxacin hydrochloride tablets and oral suspension (Cipro, made by Bayer), describing the associated risk of Achilles and other tendon ruptures.

Reports have been received by the FDA of tendon ruptures resulting in prolonged disability or requiring surgical repair in patients receiving ciprofloxacin and other quinolones. The risk may be increased in patients concomitantly receiving corticosteroids, especially in the elderly. The FDA recommends that ciprofloxacin be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.
This is a part of article Cipro - Now FDA Approved! Taken from "Generic Cipro (Ciprofloxacin) Information" Information Blog

Ciprofloxacin is also associated with the risk of pseudomembranous colitis. Discontinuation resolves most mild cases. Treatment of moderate to severe cases should involve consideration of fluids and electrolyte management, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. Drugs that inhibit peristalsis should be avoided, the FDA advised.

FDA Expands Warning to Include More Bone Cements and Bone Void Fillers

On May 7, the FDA expanded its Oct. 31, 2002, advisory to the healthcare community to include all bone cements (polymethylmethacrylate and calcium phosphate) and bone void fillers that are not specifically cleared and labeled for vertebroplasty or kyphoplasty, warning that there have been serious complications from the use of acrylic bone cements in treating compression fractures of the spine.

The FDA advises physicians to follow the labeling when using bone cement cleared by FDA for vertebroplasty or kyphoplasty. Those considering the use of bone cements and bone void fillers not cleared by FDA for this purpose should be especially attentive to patient selection, treatment techniques, potential complications, and patient monitoring. Physicians should also be aware of the literature in this area, as well as recommendations from professional organizations.
This is a part of article Cipro - FDA Expands Warning. Taken from "Generic Cipro (Ciprofloxacin) Information" Information Blog