Group Sues Seeking Action on Black Box Warning Request for Antibiotics

WASHINGTON, D.C. - A public interest group that two years ago petitioned the FDA to include a Black Box warning on certain antibiotics it says pose a significant risk of tendon rupture have sued the agency claiming it has dragged its feet on the request. Public Citizen Inc. v. Food and Drug Administration, No. 08-00005 (D. D.C.).

Public Citizen, which filed the Jan. 3 petition in U.S. District Court in Washington, D.C., says the current warnings placed on fluoroquinolone antibiotics don't go far enough to reflect the significant association with the drugs and tendinopathy or tendon rupture.

Public Citizen first …