Levaquin Lawsuits: Inadequate Warning of Tendon Damage

Fourteen more lawsuits have been filed against the manufacturers of Levaquin, a popular antibiotic that has been linked to severe tendon problems, especially in older users.

The latest suits were filed in St. Clair County, Ill., Circuit Court on behalf of consumers who said they did not know at the time they took Levaquin that itcauses a higher incidence of tendon injuries, including tendon rupture, in people who are older than 60 or who are on corticosteroid therapy.

The consumer group Public Citizen has for years been seeking more federal action to warn the public about the problems associated with the drug, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.

In August 2006, Public Citizenfiled a petitionwith the U.S. Food and Drug Administration asking that it require a “black box” warning on Levaquin, Cipro and otherfluoroquinolone antibiotics.

Black box

"The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said then. "The FDA must act and require black box warnings and patient information guides."

A black box warning was issued in July 2008, but the lawsuits charge that the revised Levaquin label still fails to warn about its higher risk of tendon toxicity compared to other similar antibiotics.

Fluoroquinolones were introduced into the U.S. in 1997 and warnings about tendon side effects were required on all labels, but were buried in a long list of potential adverse reactions, the lawsuits claim.

Injury rate tripled

In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaints.

In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suits allege.

After worldwide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic but the plaintiffs said the new warning only included information about the risks to people who were on corticosteroid therapy and contained no warnings about risks to the elderly, according to the complaints.

"Accordingly, despite the 2002 label change, Levaquin prescriptions only increased and tendon injuries mounted," the suits state.

Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaints. Injuries continued to soar as Levaquin's popularity increased, the suits state.

Companies named in the suits are Johnson and Johnson, Ortho-McNeil Pharmaceutical and Johnson and Johnson Pharmaceutical Research and Development.