FDA responds to WHO's query on ten medications

ROCKVILLE, Md. The Food and Drug Administration last week requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drugs, including the over-the-counter cough suppressant dextromethorphan. The information will be utilized by FDA in its preparation of the United States’ response to a World Health Organization query.

Dextromethorphan is the only OTC medicine on WHO’s list. The other medicines being examined include:

• Gamma-hydroxybutyric acid, a narcolepsy drug marketed in the United States under the brand name Xyrem (Jazz Pharmaceuticals) and controlled under Schedule III status (drugs with recognized medical use with a moderate to low incidence of dependence);
• the anesthetic ketamine, controlled under Schedule III status;
• benzylpiperazine, an illegal drug in the United States;
• trifluoromethylphenylpiperazine, not marketed in the United States;
• meta-chlorophenylpiperazine, not marketed in the United States;
• methoxyphenylpiperazine, not marketed in the United States;
• methylenedioxybenzylpiperazine, not marketed in the United States;
• the reagent gamma-butyrolactone, not marketed in the United States, but controlled as a list I chemical ; and
• the solvent butanediol (a scheduled substance in some states but not nationally).

WHO has called for information on these drugs to ascertain whether or not the organization should recommend that certain international restrictions be placed on distribution of the medicines.

Comments submitted to FDA are due Oct. 6. WHO meets April 20-23, 2009, to discuss the issue.