What you need to know about the new direct marketing guidance note
Nadine Mather and Chloë Loubser
FDA orders 'black box' label on some antibiotics
Earlier this week, the US Food and Drug Administration ordered the makers of certain antibiotics to add a 'black box' label warning - the FDA's strongest - to alert patients of possible tendon ruptures and tendonitis.
"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.
The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.
The consumer group Public Citizen asked the FDA in August 2006 to put the 'black box' warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.
When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.
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