Levaquin Lawsuit
Stronger Warnings Needed for Fluoroquinolone Antibiotics, FDA Says
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July 9th, 2008
"Fluoroquinolone Antibiotics Causing Tendon Ruptures"
A class of antibiotics known as fluoroquinolones needs heightened warnings about the risk of tendon rupture and tendonitis, said the U.S. Food and Drug Administration on Tuesday.
Fluoroquinolone antibiotics include:
The drugs already carry warnings about the risk of tendon problems, but the FDA suggests that the current warnings are inadequate and that “new labeling changes will better inform healthcare providers and patients about the risk.”
According to Edward Cox of the FDA, the agency “continues to receive a considerable number of reports of tendon-related adverse events.”
The Risk
The risk of tendon rupture in patients taking a fluoroquinolone antibiotic is three to four times greater than in the general population. Patients over 60, using steroid therapy, or those with certain organ transplants face the greatest risk of tendon problems, the agency said.
Individuals taking an antibiotic in this class who experience any tendon problems are advised to halt treatment and seek medical attention. Once a tendon has ruptured, it’s more difficult to treat and usually requires surgery.
FDA Sued
The FDA is currently facing a lawsuit filed by Public Citizen, a consumer advocacy group. The organization petitioned the FDA in 2006 to add a strengthened warning on the drugs’ labeling. Through the end of 2005, Public Citizen said the FDA had received:
- 262 reports of tendon rupture
- 258 reports of tendonitis
- 274 reports of other tendon disorders
An additional 100 cases have been reported since that time, said Sidney Wolfe of the consumer group.
(Source: Reuters)
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