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Tiny Matters

The rise and fall of a fake decongestant: What phenylephrine tells us about the history of the FDA

Nov 29, 2023
Deb Chakravarti, a professor with industry experience, discusses the FDA's oversight of phenylephrine in cold medicines. They explore historical cases like thalidomide and Vioxx, while also highlighting new technologies like a capsule to prevent opioid overdose. The episode reveals the complexities of drug approval and regulations, as well as innovative solutions for healthcare challenges.
28:39

Episode guests

Podcast summary created with Snipd AI

Quick takeaways

  • The FDA's history of drug approval and evolving role influenced the use of phenylephrine in cold medicines.
  • Reporting drug adverse effects is crucial for FDA to assess safety, as seen in cases like Vioxx.

Deep dives

The Approval Process for Drugs by the FDA

The FDA's advisory panel questioned the efficacy of phenylephrine, a common ingredient in cold medicines, finding it no better than a placebo. The history of drug approval was discussed, including preclinical work, four phases of clinical trials, and the new drug application process. The need for safety and efficacy in drugs has evolved over time, influenced by cases like the Littomide incident.

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