-January 4, 2007
The consumer group Public Citizen recently sued the U.S. Food and Drug Administration (FDA) to force the agency to act on a petition to increase their warnings on antibiotics.
The group wants the warnings to include information about the risks of tendon rupture that are associated with certain antibiotics.
Public Citizen Petition
In 2006, Public Citizen filed a petition with the FDA claiming that products like Bayer’s Cipro and Johnson and Johnson’s Levaquin should have “black-box” warnings due to their serious side effects.
They also asked the FDA put the warnings on the medication guides that are given to patients.
Medications with Risks
Cipro and Levaquin are a part of a group of antibiotics known as fluoroquinolones and are typically sold under different brand and generic names.
Although the drug labels warn patients of the risk of tendon ruptures, the warning isn’t contained on a black box, which is considered the strongest warning.
“Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics,” explained Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group.
Reports of Health Complications
In the petition, Public Citizen claims that a review of FDA’s database showed 262 cases of tendon ruptures, 258 cases of tendinitis and 274 cases of other tendon disorders associated with fluoroquinolone antibiotics were reported between November 1997 and December 2005.
Since 2005, Public Citizen claims that 74 additional tendon ruptures have been linked to medications such as Cipro and Levaquin.
(Source: CNN Money)
Have you or someone you know been harmed by fluoroquinolone antibiotics? If so, please contact us today to speak with an experienced attorney who will enable you and your loved ones to be compensated for any harm that has been done.
