Submit your claim details for a free, no obligation case review
Get Started:
Consumer advocacy group Public Citizen petitioned the Food and Drug Administration this week urging them to order drug makers to add stronger label warnings to Cipro and similar antibiotics.
Petitioners cited the serious risk of tendon ruptures linked with a class of antibiotics known as fluoroquinolone, commonly prescribed for respiratory, urinary tract, and gastrointestinal infections.
Public Citizen researchers evaluated the FDA''s adverse events database and discovered 262 cases of ruptured tendons in patients taking fluoroquinolones drugs between 1997 and 2005—more than 60 percent of which were linked to Levaquin and 23 percent to Cipro.
"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," said Dr. Sidney Wolfe, director of Public Citizen''s Health Research Group.
Besides the risk of tendon rupture, the group also noted about 260 reports of tendonitis and tendon disorders among patients—a risk they deem significant enough to order “black box” warnings on all fluoroquinolone class of drugs.
Furthermore, petitioners want drug makers to issue “Dear Doctor” letters updating them of potential risks of the drug and of the requested label changes.
Public Citizen together with the Illinois Attorney General''s office, is urging the FDA to compel drug makers to add a black box warning—the most severe FDA warning—to these antibiotics, including:
• Cipro
• Penetrex
• Tequin
• Levaquin
• Maxaquin
• Avelox
• Noroxin
• Floxin
Injured by a defective drug? Please contact us today to speak to a qualified and caring attorney about your legal rights and options.