Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: For recent developments regarding personal injury lawsuits that involve Levaquin and tendon-related side effects, visit the Levaquin Information page over at our Drug Injury Law web site. (7/30/09)
According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's Levaquin as well as Bayer AG's Cipro and Avelox. This Public Citizen lawsuit was filed in federal court, specifically the U.S. District Court for the District of Columbia.
In August 2006 Public Citizen petitioned the FDA to add a "black box" warning to alert doctors and patients about the risk of tendon injury and rupture associated with Levaquin, Cipro, and Avelox, as well as generic antibiotics sold under the name ciprofloxacin -- all being in the fluoroquinolones class of drugs.
According to the January 3 Reuters article about the new Public Citizen lawsuit:
The possibility of tendon rupture is now mentioned in the drug's prescribing instructions, but the warning "is buried in a long list of possible adverse reactions and is far too easy to miss," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group....
"While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented," Wolfe said.
The FDA has received 336 reports of tendon rupture in patients treated with fluoroquinolones from November 1997 through March 2007, Public Citizen said. The actual number is likely higher because only a fraction of potential side effects are typically reported to the agency.
Levaquin, Cipro, and Avelox, as well as similar generic antibiotics, are widely prescribed in the U.S. and elsewhere for gastrointestinal, respiratory, and urinary tract infections.
P.S. On July 8, 2008 the FDA announced that a so-called "black-box" Warning would be added to the package insert, or label, to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture associated with the following fluoroquinolones:
Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
Gemifloxacin (marketed as Factive)
Levofloxacin (marketed as Levaquin)
Moxifloxacin (marketed as Avelox)
Norfloxacin (marketed as Noroxin)
Ofloxacin (marketed as Floxin and generic ofloxacin)
For more details, see the July 8 press release, "FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs". (7/9/08)