DIABETES DRUGS: Advocacy Group Asks FDA to Revise Labels
Patient advocacy group Public Citizen filed a petition with the FDA Tuesday asking the agency to revise "inadequate, misleading and potentially dangerous" labels on three popular Type-II diabetes treatments, USA Today reports. Belonging to the glitazones class of drugs, Rezulin, Avandia and Actos "have several safety and efficacy problems that are inadequately described on their labels,' according to Public Citizen (Rubin, 3/8). According to their petition, all three drugs have been linked to liver and heart problems, low blood pressure and other side effects that were either not mentioned or "seriously understated" on their labels. To support their charges, Public Citizen pointed to FDA records that showed in its first 18 months on the market, Rezulin was associated with 56 cases of heart failure. Previous studies have shown a connection between several cases of liver damage (Adams, Wall Street Journal, 3/8). After reviewing hundreds of pages of government documents, Public Citizen is urging the FDA to ban Rezulin and put stronger warning labels on Avandia and Actos. Dr. Sidney Wolfe, head of Public Citizen's health research group, said, "Do not use Rezulin at all. It is too dangerous. The other two we believe should stay on the market, but ... they should not be first-choice drugs." He added that all three drugs should have stronger warning labels (AP/Baltimore Sun, 3/8).
Do Benefits Outweigh Risks?
Rezulin manufacturer Warner-Lambert said that it was working closely with the FDA to monitor the drug's side effects, and had met with agency officials as recently as last week. Spokesperson Carol Goodrich said, "The agency affirmed the benefits of Rezulin outweighed its risks" (Reuters/Contra Costa Times, 3/7). She added, "In our view, it's a thinly veiled attempt for Public Citizen to get more media coverage" (USA Today, 3/8). However, Wolfe contended that it is "outrageous that this critical information is being kept form doctors and patients" (Wall Street Journal, 3/8).