... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Floxin (ofloxacin) Tablets Prescribing Information and Medication Guide Fluoroquinolone Antimicrobial Drugs-- Floxin (ofloxacin) Tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-October 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of Changes to Contraindications and Warnings BOXED WARNING ...

... Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA Patient Safety News: Show #80, October 2008 FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin ), Factive (gemifloxacin ), Levaquin (levofloxacin ), Avelox (moxifloxacin ), Noroxin (norfloxacin ), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride). FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner's attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed. Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons are also more likely to be affected. The Achilles is the most commonly affected, but ...

... Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin ), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR ), gemifloxacin (marketed as Factive ), levofloxacin (marketed as Levaquin ), moxifloxacin (marketed as Avelox ), norfloxacin (marketed as Noroxin ), and ofloxacin (marketed as Floxin )] FDA ALERT [7 / 8 / 2008 ]: FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. ...

... FDA Patient Safety News: Show #80, October 2008 Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin ), Factive (gemifloxacin ), Levaquin (levofloxacin ), Avelox (moxifloxacin ), Noroxin (norfloxacin ), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride). FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner's attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed. Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons are also more likely to be affected. The Achilles is the most commonly affected, but ...

... MEDICATION GUIDE DRUG NAME SECTIONS MODIFIED (Click on drug name to go to detailed view) BW C W P AR PPI / MG Avelox (moxifloxacin hydrochloride) Tablets Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection) X X X MG Cipro I.V. (ciprofloxacin) for Intravenous Infusion X X X MG Cipro (ciprofloxacin hydrochloride) Tablets Cipro (ciprofloxacin) Oral Suspension X X X MG Cipro XR (ciprofloxacin extended-release tablets) X X X MG Factive (gemifloxacin mesylate) Tablets X X X X MG Floxin (ofloxacin) Tablets X X X MG Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5 %dextrose) Injection, for Intravenous Use X X X MG Noroxin (norfloxacin) Tablets X X X MG Ontak (denileukin difttox) Solution for Intravenous Use X X X X Raptiva (efalizumab) for Injection, Subcutaneous X X X X PPI Regranex (becaplermin) Gel 0.01 %X X (Click on drug name to go to detailed view) BW C W P AR ...

... Tobacco Products-FDA Home Show #80, October 2008 Show #80, October 2008 View a video of this entire show. Recalls and Safety Alerts Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin ), Factive (gemifloxacin ), Levaquin (levofloxacin ), Avelox (moxifloxacin ), Noroxin (norfloxacin ), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride). FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner's attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed. Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons ...