Kia Franklin

Public Citizen Sues FDA Seeking Stricter Drug Warnings

Public Citizen is taking the reigns and suing the FDA to force them to respond to their petition for stronger label warnings on an antibiotic drug.

Interestingly, some patients are prescribed this antibiotic to treat hospital-aquired infections, infections that they got just by virtue of being in the hospital and not as a direct result of the original condition that put them there. So basically, some patients go in for a routine surgery, get an infection, get treated for the infection, and face these risks for which they receieved no warning. How ridiculous is that? Absurd. Glad Public Citizen is doing something about it.

I feel a lesson coming on, boys and girls... This is an example of using litigation to hold the government accountable for protecting the public, and also to alert the public about potential dangers/risks that they otherwise (no thanks to the FDA) would not have known about.

From their Press Release:

Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks
Public Citizen Sues FDA in Federal Court to Force Agency to Act On Petition Seeking Stricter Fluoroquinolone Warnings

WASHINGTON, D.C. – Despite long-standing evidence that fluoroquinolone antibiotics can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.

Public Citizen sued in the U.S. District Court for the District of Columbia, asking the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. The FDA has failed to respond to the petition, which asked the agency to put a “black box” warning on fluoroquinolone antibiotics (such as Cipro, Levaquin and others) to make doctors and patients more aware of the risk of serious tendon injury before tendons actually rupture.

The petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled. Public Citizen contends that the FDA is violating the Administrative Procedure Act by not acting upon the petition.

Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics, said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

And here's an excerpt from a Newsday article on the lawsuit:

Labels [for] drugs that include the popular Cipro and Levaquin -- already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects.

The consumer group Public Citizen wants those warnings upgraded to the FDA's most severe type, a so-called black-box warning -- and for patients to get pamphlets with every bottle that describe the risk. It argues that too few patients know they're supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures.
...
When Public Citizen first filed the petition, FDA's database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen's Dr. Sidney Wolfe. Only a fraction of drug side effects typically are reported to the agency, he noted.

Visit the Public Citizen website for the full spread of info on this lawsuit and other efforts.

Kia Franklin: Author Bio | Other Posts
Posted at 3:54 PM, Jan 04, 2008 in
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