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.
Newspaper supplement highlights dangers of OTC drug abuse
WASHINGTON Three associations—the Community Anti-Drug Coalitions of America, the Consumer Healthcare Products Association and the Pharmaceutical Research and Manufacturers of America—on Wednesday introduced a new tool in the fight against medicine abuse, a 16-page newspaper supplement that aims to educate young people and parents about the dangers of abusing over-the-counter cough medicine and prescription drugs.
“Prescription medicines improve the lives of millions of patients every day,” stated Billy Tauzin, PhRMA’s president and chief executive officer. “The misuse of these medicines is tragic, and I believe we have an obligation to ensure that they are used properly. This supplement helps prevent medication abuse by actively reaching out to households and schools all across the country.”
“While national surveys show that overall illicit drug use among youth is on a downward trend, unfortunately the rates of over-the-counter and prescription drug abuse are holding steady.” commented Gen. Arthur Dean, CADCA chairman and chief executive officer. “CADCA and our partners share a common goal—to reduce the abuse of these medicines. … This project represents yet another ‘teachable moment’ that parents, community leaders and teachers can take to the youth in their lives make positive choices.”
The supplement, entitled “Stay Smart, Don’t Start: The Truth About Drugs and Alcohol,” was developed jointly by the three associations as part of its collective effort to raise awareness and fight medicine abuse.
The supplement contains information about the scope of the problem of youth alcohol, illicit drug, and medicine abuse; slang terms that teens use to describe OTC cough medicine and prescription drug abuse; and steps parents can take to prevent medicine abuse in their families. It also includes examples of what youth can do to get involved in drug prevention in their communities and helpful online resources for teens, parents, and teachers.
NTP studies find Chromax safe
PURCHASE, N.Y. Nutrition 21 on Thursday announced that study results released by the National Toxicology Program support the safety of short-term and long-term use of Chromium Picolinate.
“We are pleased with the conclusions of the NTP studies. Over the years Chromax chromium picolinate has proven to be an efficacious compound in assisting consumers to safely and proactively attain, and maintain, healthy blood glucose levels, carbohydrate metabolism, and body composition,” stated Michael Zeher, president and chief executive officer of Nutrition 21. “The results of these highly credible studies build upon the extensive database of safety data behind our products, and help provide retailers and consumers with the added confidence they need to initially buy our product and to become loyal repeat customers.”
Multiple safety studies were performed in animals, including a two-year study using daily doses of chromium picolinate equivalent to 50,000 times the common human dose found in supplements. Results of the studies can be viewed at the NTP website by clicking here.