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October 11, 1995

Adverse Reactions

JAMA. 1995;274(14):1171. doi:10.1001/jama.1995.03530140083038

Adverse Reactions by Thomas Maeder is a fascinating, carefully researched, and intelligently written book, which focuses on the discovery, development, and use of chloramphenicol. The title belies the scope of the book, which uses the chloramphenicol story as a backcloth from which to present detailed, accurate, and interesting histories of the pharmaceutical industry, the discovery and development of antibiotics, the development of drug regulations, and more.

In recent years, several drugs, such as practolol, remind us that absolute safety of drugs is unattainable and, despite rigorous approval processes, holes exist in the regulatory safety net surrounding drugs. As the first postwar drug to experience major safety problems, chloramphenicol demonstrated the complete absence of a safety net. In Adverse Reactions, the need for a national network to monitor the safety of marketed drugs is powerfully demonstrated. For example, in 1952 a formal spontaneous reporting system for adverse reactions did not exist.

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