FDA Panel Says Safety Warnings Inadequate for Fluoroquinolones

In a safety announcement issued on May 12, 2016, the U.S. Food and Drug Administration (FDA) announced label changes for fluoroquinolone drugs to warn of serious side effects associated with these drugs. The FDA says these risks generally outweigh the benefits for treating patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. The FDA says fluoroquinolones should be reserved for those who do not have alternative treatment options.

Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness. An FDA safety review has shown that fluoroquinolones used systemically—given by tablet, capsule, or injection—are associated with disabling and potentially permanent serious side effects. The side effects can occur together and can involve the tendons, muscles, joints, nerves, and central nervous system, the FDA explains.

As a result of a review and the recommendation of a drug advisory panel, the FDA is requiring the drug labels and medication guides for all fluoroquinolone drugs to be changed to reflect this new safety information.

The FDA advises patients taking fluoroquinolones to contact a health care professional immediately if they experience any serious side effects while taking the medication. Some signs and symptoms of serious side effects include tendon, joint, and muscle pain, a tingling or pricking sensation, confusion, and hallucinations. Health care professionals should discontinue systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and should switch to a non-fluoroquinolone antibiotic drug to complete the patient’s course of treatment.

Antibiotics in the fluoroquinolone category include Cipro (ciprofloxacin). Cipro was the subject of an injury suit filed in August, Law360 reports. The lawsuit was filed in Pennsylvania state court by a woman who alleges the drug’s warning label characterized the development of peripheral neuropathy from Cipro use as rare, despite scientific evidence that establishes a connection between the medication and the conditions. The woman was prescribed Cipro in September 2002. After using the drug as directed, she developed irreversible peripheral neuropathy.

The FDA approved Cipro in October 1987. By 2002, Cipro had become the world’s best-selling antibiotic, according to the legal complaint. In 1992, a Belgian doctor first established a link between the drugs and permanent nerve damage in 1992. In 2002, the FDA warned Bayer of numerous reports suggested such a relationship.

Bayer and Merck & Co. face similar lawsuits in Pennsylvania federal court over nerve damage caused by Avelox (moxifloxacin). The Pennsylvania suits say the companies spent “enormous amounts of money” to promote Avelox as the “heir apparent” to Cipro, according to Law360. Johnson & Johnson and Janssen Pharmaceuticals Inc. also face lawsuits in Pennsylvania federal court over the fluoroquinolone drug they produce, Levaquin (levofloxacin).

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