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FDA sued over antibiotic warnings

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A consumer watchdog in the US is suing the Food and Drug Administration (FDA) over claims it is ignoring calls for stronger warnings that ciprofloxacin and similar antibiotics may cause serious tendon injuries.

Labels of the fluoroquinolone family of drugs, which include Cipro and Levaquin, already warn patients about tendon ruptures and other injuries, but this information is at the bottom of a list of other side-effects.

The consumer group Public Citizen wants these warnings upgraded to the FDA’s most severe type, so-called black-box warnings.

It also claims patients should receive leaflets with every bottle that explicitly explain the risks involved.

The organisation argues that people do not realise they are supposed to stop taking the drugs if they experience symptoms such as pain or inflammation before a tendon actually ruptures.

Public Citizen filed a petition seeking the stronger warning in August 2006. The state of Illinois filed a similar petition the previous year.

The new suit filed in the US District Court for the District of Columbia claims the FDA is violating its own statutes and putting patients at risk in taking so long to resolve the issue.

An FDA spokesman said the regulator is evaluating the legal action and declined comment.

Copyright © PA Business 2008

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