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Public Citizen Sues FDA: Stricter Warning Labels Needed For Antibiotic

Press release: “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.”

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