When Medicines Harm: Fifty-One Case Histories That Shaped Pharmacovigilance

Most drug-safety rules were written after something went wrong. This book tells the story behind each one.

In 1937 an untested solvent in a new antibiotic syrup killed more than 100 people, and the United States began requiring proof of safety before a drug could be sold. In the early 1960s a sedative sold as harmless caused a worldwide epidemic of birth defects, and modern drug regulation followed. In 2004 a blockbuster painkiller was withdrawn over heart risk, and US regulators gained new powers over marketed drugs. Nearly every requirement a drug-safety professional applies today goes back to a specific failure and a specific group of patients.

When Medicines Harm collects 51 of those cases. They run from Elixir Sulfanilamide in 1937 to the end of the clozapine safety program in 2025, and include thalidomide, DES, fen-phen, Vioxx, TGN1412, contaminated heparin, Mediator, Pandemrix, nitrosamine impurities, the COVID-19 vaccines and the cough-syrup poisonings of the 2020s. Each chapter follows one case:

• Where it started: the clinical background and the first signal.
• Weighing the evidence: the explanations considered at the time and the evidence that finally settled the question.
• What followed: the regulatory response and what it changed.

Built for teaching. Every chapter includes:

• Two decision points that stop the story at a real moment and ask what you would have done with only the evidence available then.
• Lessons for practice and discussion questions.
• Fully referenced sources, including later corrections where they exist.

A scoring guide helps readers judge each decision. The epilogue draws out eight lessons that recur across the cases. The appendices summarize all 51 cases in one table, group them by how the harm was first detected, and define the key terms.

Written for:

• Drug-safety physicians and pharmacovigilance scientists
• Regulatory affairs professionals
• Trainees and students in pharmacy, medicine and public health
• Anyone who teaches drug safety through seminars, journal clubs or training programs

About the author. Dr. Hafez Selim, MD, PhD, is a safety physician at a top-ten global pharmaceutical company. He previously spent nearly a decade in safety roles at a leading medical device company. His other books include Practical Benefit?Risk Assessment in Pharmacovigilance.