PUBLIC CITIZEN SUES FDA TO "BLACK BOX" FLUROQUINOLONES.

In August, 2006 Public Citizen Health Research Group petitioned the FDA to require pharmaceutical companies to place "black box" warnings on their fluroquinolone antibiotics such as Levaquin, Cipro, Tequin, Norflexacin and others advising patients and physicians of high degree of danger to tendons, particularly of the potential of the rupture of the "Achilles" tendon. Public Citizen also requested the FDA to send "Dear Doctor" letters to physicians providing them with individualized warnings. Public Citizen reports that although there are current warnings about tendon damage from the use of the drug they are buried among a plethora of lesser potential reactions.

The FDA failed to respond to grant or deny the petition for sixteen months and Public Citizen filed suit recently in federal district court in the District of Columbia alleging that the failure to act was a violation of the federal Administrative Procedure Act. This is an effort on the part of Public Citizen to push this issue out of administrative limbo where many unpleasant administrative duties go to die unheard and unseen.
Public Citizen Health Research Group was founded by Ralph Nader and Dr.Sidney Wolf in 1971 as a public service oversight organization to watch the pharmaceutical industry. Dr. Wolf is the author of the informative book Worst Pills, Best Pills. Public Citizen is the only full time consumer "watchdog" group to keep an eye on the pharmaceutical industry. The post approval monitoring of the dangers and adverse reactions from drugs on the market is extremely sketchy. The only system is a passive surveillance process called the Adverse Event Reporting System ("AERS"), which depends upon providers taking the time to report adverse reactions to certain drugs.
Fluroquinolones are bactericidal drugs that easily penetrate cells and are useful in attacking intracellular pathogens such as Legionella pneumophilia and Mycoplama pneumophilia. There is some evidence that they tend to decrease the blood supply to tendons which already are blood shy.
Whether or not the fluroqinolones deserve further warnings it would be nice to see the court force the agency to act one way or the other and preempt what is in effect a "pocket veto" of this important public health issue.

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