We wrote about diabetes drug Avandia's dangers in June. We noted the FDA had not moved with much speed yet, which seems somewhat ironic given the rhetoric and cries surrounding the Consumer Product Safety Commission.
But while doctors continued prescribing Avandia (and its partner Avandamet and other combinations) with a warning, the Food and Drug Administration waited because of conflicting studies. Last week, the agency finally added its most strident warning, (pdf link) the black box, to Avandia and also includes a statement warning of an increased risk of heart trouble among diabetes patients who already have increased risk.
Dr. Janet Woodcock of the FDA said that pharma giant GlaxoSmithKline (NYSE:GSK) was cooperating with the agency. Woodcock also said that tests showing increased heart attack risk were tempered by longer-term studies that conflicted with the data.
The frustrating part of this issue is that months elapsed before the FDA got to this point and now years may be go by before a decision is made. Dr. John Jenkins, also speaking on behalf of the FDA, added that "So this will likely be, you know, a long term study. It could take as many as four or five years. So over that time it’ll be multiple comparisons."
Despite strong questions from The Los Angeles Times' Ricardo Alonso-Zaldivar, FDA representatives refused to address the issue of the agency's own safety officers calling for the drug's removal from the market. Alonso-Zaldivar pushed well, but was eventually silenced. Follow-ups from The Wall Street Journal and other media outlets were similarly stonewalled. FDA officials also refused to disclose the panel's vote and other information that will undoubtedly be challenged with a Freedom of Information Act request.
For now, diabetics taking Avandia or one of the two commercially available compounds containing Avandia are strongly urged to talk with their physician about whether this drug is appropriate for them.
Labels: Avandia, FDA, Glaxo, GSK
