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Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality U.S. Food and Drug Administration Search FDA Home Safety MedWatch The FDA Safety Information and Adverse Event Reporting Program Information Safety Alerts for Human Medical Products Safety Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality [Posted 07/01/2015] AUDIENCE: Family Practice, Consumer, Pediatrics ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. Unapproved prescription otic drug products containing the following ingredients are covered by this action: benzocaine; benzocaine and antipyrine; benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol, and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine, and hydrocortisone. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM] Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality BACKGROUND: FDA informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter. RECOMMENDATION: Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800FDA-0178 [07/01/2015 - News Release - FDA] [07/01/2015 - Consumer Update - FDA] More in Safety Alerts for Human Medical Products 2015 Safety Alerts for Human Medical Products 2014 Safety Alerts for Human Medical Products 2013 Safety Alerts for Human Medical Products 2012 Safety Alerts for Human Medical Products Page Last Updated: 07/01/2015 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Careers U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) FDA Basics FOIA No Fear Act Site Map Transparency Website Policies Contact FDA http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM] Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality FDA Archive Emergency Preparedness Federal, State & Local Officials International Programs Consumers Advisory Committees News & Events Health Professionals Regulatory Information Training & Continuing Education Science & Research Safety Inspections & Compliance Industry Combination Products http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM]