Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk

Executive Summary

FDA's risk evaluation and mitigation strategy for fluoroquinolone antibiotics requires manufacturers to survey patients and prescribers to make sure they understand the risks of tendon injury associated with the products

You may also be interested in...

Fluoroquinolones Get New Safety Labeling, But Not A REMS

Risk of disabling, potentially permanent serious side effects that can occur together will be added to Cipro, Levaquin labels along with limitation against use for some self-limiting conditions unless there are no alternative treatments.

FDA Adverse Event Data Clouds Potential Fluoroquinolone Label Changes

Advisory committee unsure how to describe fluoroquinolone-associated disability in labeling.

Fluoroquinolones Need REMS With Communication Plan, AdCom Says

Overwhelming votes against existing labels for the antibiotics likely means sponsors and FDA have some safety planning to do.

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts