FDA Requires Safety Label Changes For Merck & Co., Inc. (NYSE:MRK) Avelox, Johnson & Johnson (NYSE:JNJ) Levaquin, Others

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The US Food and Drug Administration (FDA) has approved on Tuesday amendments on fluoroquinolones safety labeling to prevent the use of the said antibiotics among patients with mild bacterial infections. The affected fluoroquinolones brands include Avelox (moxifloxacin) from Merck & Co., Inc. (NYSE:MRK), Cipro (ciprofloxacin) from Bayer AG (ADR) (OTCMKTS:BAYRY), Factive (gemifloxacin) from Oscient Pharmaceuticals Corp., and Levaquin (levofloxacin) from Johnson & Johnson (NYSE:JNJ). Generic fluoroquinolones are also included.

Safety Labeling Changes

As per the mandate of the FDA, all fluoroquinolones will now need to have revised Warnings and Precautions sections and Boxed Warning labels. These must clearly state the risk of countering the sometimes irreversible side effects that may result from taking the antibiotics. Moreover, the new safety labels must also clearly disclose certain limits of use, stating that fluoroquinolones are only recommended for patients who have no other alternative treatments for acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infection (UTI). More importantly, the patients prescribed with fluoroquinolones must be given a Medication Guide that elaborates the risks relating to the said antibiotics.

As Edward Cox, M.D., FDA Center for Drug Evaluation and Research Director of Antimicrobial Products, said, fluoroquinolones need to be deployed carefully because of the serious risks associated with them. Consequently, providing clear warning labels about these factors will allow healthcare providers and patients alike to make informed decisions regarding its use.

Fluoroquinolones Therapeutic Benefits and Safety Risks

Fluoroquinolones are effective antibiotics, which is why many brands and generics have already been approved by the FDA. Nonetheless, a recent FDA safety review has discovered that fluoroquinolones— whether given intravenously or orally— come with disabling side effects relating to the central nervous system, joints, muscles, nerves, and tendons. These side effects can potentially last a lifetime, outweighing the therapeutic benefits of fluoroquinolones especially for those who are suffering from anthrax and bacterial pneumonia, among others.

Due to this and despite having a Boxed Warning since 2008, Merck, Bayer, Oscient, Johnson & Johnson, and other fluoroquinolone makers have continuously been receiving thousands of legal complaints relating to their respective fluoroquinolones and the associated side effects.

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