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Levaquin Manufacturer Hit With Three More Suits

Claims allege permanent tendon damage

By Jon Hood
ConsumerAffairs.com

September 16, 2009

Levaquin • Levaquin Manufacturer Hit With Three More Suits • FDA Wants Black Box Warning on Antibiotics • Antibiotic Leads to Tendon Ruptures • Public Citizen Warns of Cipro, Levaquin Dangers --- • Consumer Complaints about Levaquin --- • More drug safety news ...

The manufacturer of Levaquin is facing three lawsuits from consumers who claim the medication caused them permanent tendon injuries. The actions follow a similar lawsuit filed two weeks ago.

The latest suits were filed by Illinois residents who took the drug and say they suffered serious tendon damage as a result. All three groups are represented by Corey & Danis and the Lowe Law Firm, which also brought the earlier suit.

The plaintiffs allege that they were unaware of the increased risk of tendon rupture for patients over 60 or those who are on corticosteroid therapy, which uses steroids to fight osteoperosis, arthritis, and a number of other ailments.

Levaquin is part of a group of antibacterial drugs called fluoroquinolones, used primarily to treat infections by halting the reproduction of bacteria. U.S. law requires makers of such drugs to warn on the label of tendon-related side effects. Although manufacturer Ortho-McNeil technically warns of potential tendon problems, the notice is buried in a long list of other side effects, according to the suits.

After a number of studies showed that the medication poses a risk of tendon damage to certain groups of patients, Ortho-McNeil updated the label to specifically warn of an increased risk to patients involved in corticosteroid therapy, but failed to note the risk posed to older patients.

This is disturbing for several reasons. According to the suit, Ortho-McNeil actively marketed Levaquin to older consumers with a "campaign ... themed on Levaquin's excellent safety profile [that] failed to disclose the risks of tendon injury." Moreover, elderly patients are especially likely to use corticosteroid therapy for upper respiratory infections and other problems.

Studies have linked fluoroquinolones to a number of other potentially serious side effects, including psychosis, depression, changes in heart rhythm, and, in severe cases, seizures. Along with requiring a "black box" warning detailing the danger of tendon damage, the Food and Drug Administration (FDA) has cautioned doctors to carefully weigh the risks and benefits posed by the drug before prescribing it to patients.

Levaquin was first approved by the FDA in 1996, and has since become a popular antibiotic; $2.3 billion in sales in 2005.

Other fluoroquinolones posing an increased risk of tendon damage or rupture include Cipro, Proquin, Factive, Levaquin, Avelox, Noroxin, and Floxin. However, the FDA says that Levaquin is especially dangerous, accounting for 61% of all fluoroquinolone-caused tendon injuries between November 1997 and December 2005. According to Carey & Danis, one of the firms prosecuting the suit, the Achilles is the tendon most susceptible to injury, with the hand, rotator cuff, and biceps close behind.

Along with Ortho-McNeil, the suit names as defendants Johnson & Johnson -- the manufacturer's parent company -- and Walgreen's, which sold the drug.

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