FDA Strengthens Warnings for Levaquin, Other Fluoroquinolone Antibiotics

Published on May 13, 2016 by Sandy Liebhard

Federal health regulators are warning that Levaquin and other antibiotics called fluoroquinolones may cause a number of serious complications, including muscle and nerve damage. The U.S. Food & Drug Administration (FDA) is now advising that the use of these medications be restricted for patients with certain uncomplicated infections.

In addition to Levaquin, the fluoroquinolone class includes Cipro, Avelox and generics. The drugs are frequently prescribed, with more than 36 million scripts written in 2014. However, the medications have been under scrutiny for several years because of a possible association with serious tendon injuries, peripheral neuropathy, and more. This past November, the FDA convened an advisory panel meeting to determine whether or not the risks associated with fluoroquinolones outweighed their benefits when used to treat a number of uncomplicated infections. The panel overwhelmingly recommended new warnings for the drugs’ labels.

In a Drug Safety Communication issued on May 11^th, the FDA recommended that the use of Levaquin and other fluoroquinolones be restricted for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.  A new boxed warning will be added o the labels of all fluoroquinolone antibiotics stating that their risks generally outweigh their benefits for patients with these types of infections.

The FDA noted that its recent review suggested that Levaquin and other fluoroquinolones were associated with a number of disabling complications, including problems that affect the tendons, muscles, joints, nerves and central nervous system.  According to the agency, these side effects are potentially permanent, and can occur together. Patients using these antibiotics should contact their doctor immediately if they experience tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucination. Doctors should cease fluoroquinolone treatment in patients who report serious complications.

Fluoroquinolone Litigation

In recent years, hundreds of people have sought compensation for serious injuries allegedly associated with the use of fluoroquinolone antibiotics. In Minnesota federal court, more than 200 peripheral neuropathy lawsuits have been filed on behalf of patients who claim to have developed the debilitating nerve condition as a result of Avelox, Cipro or Levaquin. Dozens of similar claims are pending in state courts around the country.

At one point, more than 3,400 Levaquin lawsuits had been filed in U.S. courts on behalf of plaintiffs who allegedly experienced tendon damage due to its use. However, all but a few hundred of those claims had been settled as of May 2014.