In 1938 a “miracle drug” came into use. It was marketed as a pediatric elixir.
Raspberry-Flavored Anti-Freeze
It was a raspberry flavored solution in a liquid industrial solvent
called di-ethylene glycol, also known as anti-freeze.
Generally, an elixir is designated as an alcohol-based product, but this particular formulation was of di-ethylene glycol. Upon ingestion, ethylene glycol was metabolized to oxalic acid.
The manufacturing company tested the elixir only for its appearance and palatability before its nationwide distribution.
The Tragedy
204 gallons of this elixir were produced in 1938 leading to 358 poisonings, 107 deaths with 251 getting extremely sick but surviving.
Lessons Learned
So what GMP lessons can we learn from this?
The safety of each drug should have been established, as per written and approved standard operating procedures, before releasing drugs into the market.
Proper quality control and assurance practices should have been established.
In retrospect a simple animal study would have probably stopped this from getting to the public.
Also, as a result of this The Food, Drug and Cosmetic act of 1938 was established thus giving the FDA authority to act and inspect.
