The American drug regulatory board, the Food and Drug Administration, spoke out at a House hearing on Wednesday to confirm that they would add the most serious health warnings to the boxes of two major drugs for diabetics – Avandia and Actos. The changes come about following major controversy over the risk posed to diabetic patients by Glaxo drug Avandia.
In the past, the safety reviewers for the FDA recommended this move. A congressional investigation into why these plans were delayed is currently underway. Now, the commissioner for the FDA, Andrew von Eschenbach, claimed that the agency have asked the manufacturers of both drugs to add the warnings. According to a statement, this is because: "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."
The extent of the risk posed by Avandia and Actos is yet to be fully revealed. Takeda pharmaceuticals, who manufacture Actos, have quickly responded to FDA warnings. Despite this, the agency is under criticism. The chairman of the panel at the current hearing, Henry Waxman, reportedly commented: "Avandia is a case study of the need for reform of our drug safety laws. FDA needs the will, the resources and the authority to be a more effective watchdog of drug safety."
Strictest health warning on diabetes drugs
Fri, 08 Jun 2007
