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The US Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a “boxed warning” in the product labeling concerning the increased risk of tendonitis and tendon rupture is necessary.
Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a medication guide to patients about possible side-effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The medication guide will be considered to be an element of the REMS. The new boxed warning and medication guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
“Fluoroquinolones are effective in treating certain bacterial infections, but healthcare professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendonitis and tendon rupture, particularly for certain patient populations,” said Edward Cox MD, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.
“The FDA believes it is important to highlight and strengthen information regarding possible side-effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”