New Drug Safety Communication on Fluoroquinolone Antibiotics – Drug Information Update

Cuidado con las fluorquinolonas Drug Information Update The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA. —————————— The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the *Boxed Warning*, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide. We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option. *Patients* must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns. *Health care professionals* should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. For more information, please visit: Fluoroquinolone Antibiotics . —————————— This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am – 4:30 pm ET Monday – Friday. You can also email us at – For additional drug information, please visit the DDI Web page . – For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info . – This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA) . —————————— [image: FDA Logo] Subscriber Services: Manage Preferences | Unsubscribe | Help with this service Stay Connected: [image: Visit Us on Facebook] [image: Visit Us on Twitter] [image: Visit Us on YouTube] [image: Sign up for email updates] [image: Visit Us on Flickr] [image: Visit Our Blog] —————————— This email was sent to using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) [image: Powered by GovDelivery] Enviado con MailTrack

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