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FDA orders Stronger Warning Labels for Antibiotics

Timely Insights on Laws, Issues and New Developements

CiproOn May 12, 2016, the U.S. Food and Drug Administration advised against the use of a class of antibiotics known as fluoroquinolones for the treatment of certain infections in patients with other treatment options.

FDA said the serious side effects associated with fluoroquinolones outweigh the benefits for patients with alternative treatment options. These “side effects” (a euphemism for “actual effects”) include disabling, potentially permanent damage to tendons, muscles, joints, nerves and the central nervous system. The agency is requiring that updated drug labels and medication guides reflect the new safety information.

Avelox, Levaquin, Cipro, Others

Brand-name fluoroquinolones include Avelox, marketed by Merck & Co. Inc.; Levaquin, marketed by Johnson & Johnson; Cipro, marketed by Bayer; and a few others.

 FDA-approved Fluoroquinolone Antibacterial Drugs

Brand NameActive Ingredient                         Maker
AveloxMoxifloxacin                                                     Merck
CiproCiprofloxacin                                                    Bayer
Cipro extended-releaseCiprofloxacin extended-release          Bayer
FactiveGemifloxacin                                                 GeneSoft
LevaquinLevofloxacin                                     Johnson & Johnson
Moxifloxacin InjectionMoxifloxacin                                        Bayer
OfloxacinOfloxacin                                          Ortho-McNeil-Janssen

The FDA announcement comes after an advisory committee ruled in November 2015 that fluoroquinolones lack adequate safety warnings. Law 360 reported that the committee determined in several unanimous and near-unanimous votes that the antibiotics’ labels gave inadequate warnings for the treatment of acute bacterial sinusitis, urinary tract infections and acute bacterial problems that complicate chronic bronchitis in patients with chronic obstructive pulmonary disease.

Fluoroquinolone Patients cautioned

Patients taking fluoroquinolone medications and experiencing any serious side effects, including tendon, joint and muscle pain, “pins and needles” tingling sensation, confusion, hallucinations, should notify their doctors immediately. Health care professionals, meanwhile, should stop using the drug if a patient reports such symptoms. FDA said the patient should be switched to a non-fluoroquinolone drug.

FDA orders Stronger Warning Labels for Antibiotics

The FDA said that it’s continuing to investigate safety issues related to fluoroquinolones and will update the public if additional information becomes available.

Antibiotic Lawsuits

The antibiotic class  of fluoroquinolones has been the subject of several lawsuits.

Earlier in 2016, Pennsylvania state Judge Jacqueline F. Allen denied plaintiffs’ attempts to consolidate 32 cases filed in the Philadelphia Court of Common Pleas against Bayer, Merck and others. The plaintiffs in those cases have argued that antibiotic drugmakers hid the risk of permanent nerve damage resulting from fluoroquinolones.

Levaquin Lawsuit

In January 2016, U.S. District Judge Manish S. Shah, in Illinois, denied Johnson & Johnson’s bid to dismiss a lawsuit brought by a man who blames Levaquin for several serious physical injuries. That plaintiff accuses Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. of failing to adequately test the drug, make it safely, or warn people of its risks.

The plaintiff said he took Levaquin for just five days in October 2010 to treat an infection. Between then and early 2011, he began to experience many physical problems, he said, including tendon and joint issues, neurological, and gastrointestinal problems.

Antibiotic Nerve Damage Linked in 1992

Law 360 reports that a “Belgian doctor first established a link between fluoroquinolone drugs and permanent nerve damage in 1992.”  The FDA told Bayer in 2002 that several reports suggested such a relationship.


  • FDA Warning on Fluoroquinolones
  • Z-pak Zithromax Antibiotic Lawsuit
  • Levaquin Lawsuit
  • FDA orders Stronger Warning Labels for Antibiotics

by Matthews & Associates

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