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Lawsuit seeks black box on antibiotics
Lobbying didn't work, but maybe a lawsuit will. Public Citizen sued the FDA yesterday, hoping to force the agency to pin stronger warnings on a class of antibiotics known as fluoroquinolones, which includes Bayer's Cipro and Johnson & Johnson's Levaquin.
The consumer group had petitioned the agency for a "black box" warning that the drugs can cause tendon rupture. Currently, that potential side effect is included in a long list of possible adverse events on the drug's label. Public Citizen said that 262 tendon ruptures, 258 cases of tendonitis, and 274 other cases of tendon disorders in patients using the antibiotics were reported to the agency between 1997 and 2005.
Of course, the reports don't prove that the antibiotics caused the problems. But Public Citizen maintains that a stronger warning is warranted so that tendon problems can be flagged before major injuries happen. Neither the FDA nor Schering-Plough, which makes the drug in partnership with Bayer, would comment on the suit. J&J says the current warning is perfectly adequate.
- see Public Citizen's release
- read the legal complaint
- here's more from the AP
Comments (1) | Post a comment
Comments
By Mr. David T. Fuller | Posted 1:04am | January 5, 2008
"Of course the reports don't prove that the antibiotic caused the problem"
But the 4000 plus medical journal entries, clinical studies, case reports and the like that has been published in the leading medical journals or reported to the FDA every year since 1982 does.
Let us not forget that this is about the sixth petition filed by Public Citizen since 1996 regarding the severe and non abating adverse drug reactions associated with this class since their introduction. As well as the petition filed by the Attorney General of the State of Illinois that was filed in 2005 demanding these same warnings. And the response has been the same "we are continuing to investigate..."
An investigation that has been ongoing for almost twenty six years now. I think Public Citizen has been quite patient all things considered having not filed this twelve years ago.
Those who have an interest in reading these studies and articles are invited to log unto www.fqresearch.org where such articles have been made available on line since 2000.
It is our intention to file an Americus Brief in this case and present these studies to the Court.
Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
fqresearch@aol.com
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