• Most Heinous Drug Approval (other than opioids)
• FDA Knowingly Accepts Fraudulent Data
Toxic Drugs
Featured Editorials
FDA's Role in the Problem:
The FDA has approved several dangerous drugs while suppressing safer alternatives. The case of Trasylol®, a Bayer drug used in surgeries, is one such example—despite evidence of severe kidney damage, the FDA expanded its approval, leading to thousands of unnecessary deaths. Similarly, acetaminophen has been linked to liver and kidney toxicity, yet it remains widely available without adequate consumer warnings. Another example is Ketek whereby the FDA knowingly accepted fraudulent safety data, approved the drug, and withdrew it only after dozens of cases of severe liver failure were reported.
Congress should enact stricter post-market surveillance policies to hold the FDA accountable for dangerous approvals. The regulatory focus should shift toward protecting public health rather than catering to pharmaceutical profits. Additionally, policymakers should encourage comparative effectiveness research to identify safer alternatives.
Proposed Policy Solutions:
