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FDA Considers Whether to Schedule DXM
Manufacturer Blames Erowid for Abuse
by Fire Erowid
Nov 2010
Citation:   Erowid F. "FDA Consideres Whether to Schedule DXM". Erowid Extracts. Nov 2010;19:3.
Dextromethorphan (DXM) has been available as an over-the-counter cough suppressant for more than 50 years. It was developed in part as a replacement for codeine-containing cough treatments that were being used non-medically. DXM tablets produced by Romilar were removed from the market in 1973 because of recreational use. DXM in syrup form remained available, as the unpleasantness of consuming it in large quantities was seen as a deterrent to "abuse".

"[...] he knocked on the door in Flushing to find a houseful of naked people stoned out on Romilar cough syrup."
-- A scene from 1962 described in The Sackbut Tapes by Natty Bumppo
But recreational use didn't stop. In 1990, the U.S. Food and Drug Administration (FDA) convened an advisory committee to consider DXM's abuse potential. The committee recommended that additional toxicity data be provided and that more epidemiological data be gathered. In 1992, the committee reconvened to discuss epidemiological studies and concluded that "abuse" was contained to small communities and that additional studies should be conducted.

During the 1990s, the use of DXM-containing cough syrups, primarily by teens, became a well-known phenomenon among recreational drug-using communities. In response to what we viewed as fairly widespread misinformed use, Erowid began providing information about DXM in 1996. At the request of the DEA, on September 14, 2010, a Drug Safety and Risk Management Advisory Committee of the FDA again held a hearing to consider the abuse potential of DXM and to recommend whether it should be scheduled in the United States.

The 15-member advisory panel included industry representatives, addiction experts, professors, researchers, epidemiologists, pharmacologists, psychiatrists, and harm reduction workers. Formal presentations were made on the history, pharmacology, and abuse potential of DXM, with comments by pharmaceutical industry representatives.

Discussion covered how much DXM is sold over-the-counter in the U.S. (167 million bottles in 2009), rates of use by 12-17-year-olds (~2% report use in the last year), risks of use (5 deaths attributed to DXM alone were cited, though many deaths and hospitalizations have been associated with products containing DXM in combination with other drugs), alternatives to scheduling (age restrictions or availability behind-the-counter only), and consequences of scheduling (loss of access by those with need).

"We're going to have to fight the aerowits."
-- S. Pasierb, President and CEO of the
Partnership for a Drug-Free America
This advisory committee meeting was brought to our attention by several people who noticed that Erowid was mentioned. The first mention was by Bob Sosnowski, the founder of DexGen Pharmaceuticals, a company that produced a single-agent DXM gel cap in the U.S. He suggested that Internet sites like Erowid ("aerowit" in the transcript) were to blame for the recreational use of DXM, an amusing assertion coming from a commercial drug manufacturer--especially given that 37 years ago a DXM product was removed from the market due to recreational use.
"That research led us to understand the illicit demand for dextromethorphan on certain Internet cites including aerowit, DXM, dextroverse, I would encourage you all to look at these [...]. These cites claimed to promote safe, recreational use of dextromethorphan and provided tips such as how to extract dex from combination products and how to avoid overdosing on dex. These cites also claimed to be doing a public service by advising users not use Coricidin HBP because of the potential that chlorpheniramine maleate, an ingredient in combination products, can cause death when abused."
Then, during a discussion of how to educate parents and especially teens about the dangers of DXM, Stephen Pasierb, the President of the Partnership for a Drug-Free America declared, "We're going to have to go to MySpace and fight Website with Website. We're going to have to fight the aerowits."

Curiously, none of the presenters argued that DXM should be scheduled; indeed, speaker after speaker presented reasons for why it should not be. A Consumer Healthcare Products Association representative stated they did not believe that scheduling was warranted, but that they are concerned about abuse. Their four-fold plan is to increase parental awareness, increase teens' perception of risk, increase social disapproval, and limit access points. Charles Schuster, former director of the National Institute on Drug Abuse, recommended against scheduling due to DXM's "limited abuse potential and low level of actual abuse, especially considering its widespread availability and use". He also pointed out that negative effects increase with dose in tandem with the effects sought by users, further limiting abuse potential.

Several speakers described needing to be careful when talking about DXM abuse, in order to not inadvertently increase use simply by talking about it. While we understand this concern, if there are people using DXM recreationally, information about this use must remain available.

At the end of the day, the committee voted 15 to 9 against scheduling DXM.

The full transcript of the meeting is available here as a PDF.

Revision History #
  • v1.0 - Nov 2010 - Fire Erowid - Published in Erowid Extracts.
  • v1.0 - Mar 3, 2011 - Published on