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Public Citizen seeks 'black-box' warning for popular antibiotics.

The consumer advocacy group Public Citizen has asked a federal district court to force the FDA to act on the group's petition asking the agency to require a "black-box" warning on the product labels of a certain category of antibiotic drugs marketed in the United States. (Public Citizen, Inc. v. FDA, No. 1:08-CV-00005 (D.D.C. filed Jan. 3, 2008).)

Citing the risk of serious tendon injury associated with Cipro (ciprofloxacin), Levaquin (levofloxacin), and other fluoroquinolone antibiotics, Public Citizen filed its labeling request with the FDA on August 29, 2006. The petition asked the agency to require manufacturers to add a black-box warning, send a "Dear Doctor" letter to physicians about the risk, and distribute an FDA-approved medication guide to be dispensed to patients when prescriptions for the antibiotics are filled.

The FDA's only response to the petition came on February 26, 2007, when the agency said it had not yet reached a decision because the petition raised "complex issues requiring extensive review and analysis by agency officials."

After waiting 16 months without any action by the FDA, Public Citizen filed the lawsuit. The group alleges that the FDA's failure to act on the petition constitutes an agency action "unlawfully with held or unreasonably delayed" in violation of the federal Administrative Procedure Act, in light of the "nature and extent of the public health interests prejudiced" by the delay.

"The lawsuit is aimed at forcing the agency to act as it should," said Michael Kirkpatrick of Washington, D.C., the Public Citizen attorney who filed the complaint. "The issue comes down to, how long a delay can the agency take [on the petition] before it becomes unreasonable?"

Fluoroquinolone antibiotics are widely prescribed for the treatment of a variety of urinary tract infections, respiratory infections, prostatitis, and other types of bacterial infections. Although researchers are still investigating exactly how fluoroquinolones cause tendon injuries, studies suggest that they can degrade tendon cells. Tendons then easily tear or rupture.

Public Citizen first petitioned the FDA to place a warning about the risk of tendonitis and tendon rupture on the package inserts for all the fluoroquinolones on the market in 1996. That petition was successful. In 2002 and again in 2007, the label was further amended. It now states that the risk of tendon injury is higher in patients who take corticosteroids at the same time, especially the elderly.

However, according to Public Citizen's complaint, "the simple nonbolded warning buried in the list of possible adverse reactions to fluoroquinolones has proved to be inadequate," and fluoroquinolone-induced tendon injuries "continue to occur at an alarming rate."

The complaint notes that from November 1997 through December 2005, the FDA adverse event database received reports of 262 cases of tendon ruptures, 258 cases of tendonitis, and 274 cases of other tendon disorders in patients using the drugs. The database has received additional injury reports since the end of 2005, for a total of 336 cases of tendon rupture since November 1997, Public Citizen says.

"Given the importance of the issue and given the continuing reports of injuries that could be prevented if physicians and patients were better advised," a more pronounced black-box warning is needed, Kirkpatrick said. He also noted that the warning is imperative because no other class of drugs has as high an incidence of tendon injuries and because people do not expect such kinds of injury from an antibiotic.

But Lewis Saul, who chairs AAJ's new Levaquin litigation group (see story on p.11), said that even the stronger warning sought by Public Citizen would be inadequate because it would apply to all fluoroquinolone drugs as a class. He said it would not alert doctors and patients that Levaquin is many times more toxic to the tendons than the other fluoroquinolone antibiotics.

"Levaquin is really much, much worse than the other fluoroquinolones," especially in people over 60 years old who took it along with a corticosteroid, he said.

Saul said about 20 tendon-injury lawsuits have been brought against Johnson & Johnson and its subsidiary Ortho-McNeil Pharmaceutical, which manufacture and distribute Levaquin. The claims include strict products liability for manufacturing and design defect, and strict liability for failure to warn.

Most of the cases have been filed in federal district court in Minnesota. The first trial date has been set for May 2009. (Voss v. Johnson & Johnson, No. 06-CV03728 (D. Minn. filed Dec. 17, 2007).)
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Author:Heylman, Susan
Date:Apr 1, 2008
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