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 [1]
- read the legal complaint [2]
- here's more [3] from the AP
Links:
[1] http://www.fiercebiotech.com/press-releases/antibiotic-leads-tendon-ruptures-fda-ignores-risks
[2] http://www.citizen.org/documents/ciprocomplaint.pdf
[3] http://money.cnn.com/news/newsfeeds/articles/apwire/3c95b13dd5948e91aba6e5aca1e1bf89.htm