Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

NDMA FUNDING DEXTROMETHORPHAN ABUSE PREVALENCE STUDIES THROUGH PEGUS RESEARCH, a University of Utah affiliate that conducts epidemiology and toxicology research, Nonprescription Drug Manufacturers Association Senior VP and Director of Science & Technology William Soller, PhD, told FDA's Drug Abuse Advisory Committee at its July 14 meeting. PEGUS also has been recruited to conduct studies on: the characteristics and habits of abusers of the OTC antitussive ingredient; the nature and extent of dextromethorphan abuse in schools in communities with a serious abuse problem; and the impact of educational intervention on dextromethorphan abuse in affected communities. The first two studies are anticipated to be completed this autumn. NDMA also has recruited the Center for Applied Prevention Research, a nonprofit group involved in preventing alcohol and drug abuse, which plans to set up a library of information on dextromethorphan abuse and develop educational materials for intervention and prevention programs for communities with abuse problems, Soller told the committee. The July 14 committee meeting was held to provide an update from available databases on dextromethorphan exposures and to evaluate NDMA's efforts to address the apparent dextromethorphan abuse problem through educational programs in the two years since the issue first came before the committee ("The Pink Sheet" Aug. 13, 1990, p. 9). At the 1990 meeting, NDMA said it had developed awareness and prevention programs on the proper use of OTCs and would continue to study the problem to further characterize the scope of regional incidents of reported dextromethorphan abuse. Gerald Keenan, now a physician's assistant with the Pennsylvania Department of Health, discussed the widespread abuse of dextromethorphan-containing cough/cold products by teenagers in Waynesboro, Penn. Keenan said that teenagers abuse A. H. Robins' Robitussin-DM and Rich-Vick's Formula 44, Formula 44D, and NyQuil. The committee concluded that to determine the scope of abuse more epidemiology and toxicology data would have to be gathered. Responding to data presented at the latest communittee meeting, Cheri Groesbeck, Phlebotomy Training Association, Sandy, Utah, said she is "disappointed in the amount of information that's been brought to us in two years," adding "I feel like everything...I've heard [today], I heard two years ago." George Bigelow, PhD, Johns Hopkins/Key Medical Center, said: "I find it frustrating searching around for [data when] at least one community, maybe several communities, are saying that no one is paying attention to them, and the industry is saying that they're floundering around trying to find the problem." FDA Pilot Drug Evaluation Staff Director John Harter, MD, suggested that drug companies that make dextromethorphan- containing OTC cough/cold products work together with researchers in the communities where outbreaks of abuse occur to determine the extent of abuse and the reasons for it. Harter added that he hopes the advisory committee can meet in a year to discuss the first two NDMA-sponsored studies. The committee heard DAWN (the Drug Abuse Warning Network) data from emergency rooms and medical examiners and dextromethorphan exposure data from the National Poison Control Center. James Anthony, PhD, John Hopkins University School of Hygiene and Public Health, described unpublished DAWN data by McElwee et al., stating that from 1987 to mid-1990 there were 113 emergency room mentions of dextromethorphan alone or in combination with other drugs. Of those mentions, 27% involved dextromethorphan only, Anthony said. None of the episodes resulted in death. The medical examiner reports from 1987 through 1989 involved 114 deaths that "were associated with some other product." Anthony also presented unpublished data by Page et al. from the National Poison Control Center database that tracked over 6 mil. drug exposures during 1985 to 1989. "Of those, 19,000 or so were [dextromethorphan] mentions and they were able to classify 4.6[%] of them as clear abuse cases" as opposed to accidental ingestions, Anthony said. There was an "increasing trend in these abuse cases from 24 to 194," he noted. "Again, zero deaths were reported [and] only two events were of life- threatening severity." After hearing the presentations, FDA Pilot Drug Evaluation Staff Medical Reviewer Curtis Wright, MD, concluded that: "We're back here two years later and we're pretty much [in] the same place we were two years ago." Wright pointed out that normal methods for detecting drug abuse "strike out with this agent." He noted that "medical examiner mentions aren't very good; emergency room visits and the DAWN system aren't very good."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts