Regulatory Impact of Selected U.S. <scp>FDA</scp> Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions

While six non-pregnancy registries did not detect a new safety signal, four did not produce safety results considered sufficiently robust to warrant specific regulatory action including safety-related labeling updates. The lack of safety signal detection in these observational studies should not imply the absence of safety signals. Appropriately designed, prospective, randomized controlled safety studies are the most reliable way to obtain interpretable safety data.