The FDA Erred with Oxycontin. Here’s the History they Ignored.

August 17, 2026by Chris Aiken, MD0

Opium is the sap of the poppy plant, used for 5,500 years. Morphine is the first commercial extract of opium, marketed by Merk in 1817. Since then, the industrialized opioids have grown in potency, addictive potential, and overdose risk.

Concerns about oxycodone’s addiction potential surfaced within two years of its 1917 debut, long before Perdue Pharma claimed otherwise

STUDY: Samways DSK and Blatchford Z, Addiction 2026

STUDY TYPE: Narrative review

FUNDING: Independent

Background

In December 1995, the FDA made two consequential approvals.

  1. Saquinavir, the first anti-retroviral for HIV.
  2. OxyContin, a controlled release version of oxycodone, where they allowed Perdue Pharma to claim that the release system lowered its abuse liability to “very rare.”

800,000 opioid-related deaths later, that second decision has come under scrutiny. This review traces oxycodone’s history back to its 1917 German debut (branded then as Eukodal), and finds the problem was known — and downplayed — every step of the way.

First, some terminology:

  • Oxycodone: Generic, instant release opioid, branded as Eukodal and later as Roxicodone
  • Other brands combine oxycodone with Tylenol (Percocet, Endocet, Oxycet), aspirin (Percodan), or ibuprofen (Combunox)
  • Oxycontin: First controlled release oxycodone (followed by Xtampza ER)
  • Roxybond and Oxaydo: Abuse deterrent oxycodone (released in 2015 and 2017)

Summary

Physicians raised concerns within two years of oxycodone release as Eukodal. A 1919 report described tolerance and withdrawal similar to morphine’s, and further German case reports through the 1920s described patients injecting up to 40 ampoules a day. 30% of physicians had treated patients dependent on the drug in a 1928 survey.

In the 1930s, the National Research Council’s Committee on Drug Addiction and Narcotics tested oxycodone directly and confirmed it produced morphine-equivalent withdrawal severity. Despite this, the committee accepted industry arguments that combination products like Percodan, because they paired oxycodone with aspirin, carried little addiction risk. That reasoning helped Percodan reach easier prescribing status in 1954, and diversion in California surged so quickly that regulators reversed course by 1963, restoring stricter controls.

In 1995, Purdue used the same argument, that formulation determines risk rather than the opioid itself, decades later to promote OxyContin.

Practice Implications
  1. Think twice when a manufacturer claims a new formulation is has less addiction risk.

—Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report

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