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Postmarketing Surveillance for Drug Abuse Supports Nonscheduled Status of Tramadol

Postmarketing Surveillance for Drug Abuse Supports Nonscheduled Status of Tramadol

ST. LOUIS--When tramadol (Ultram) received FDA approval last year
for use in moderate to moderately severe pain, its abuse potential
was felt to be low (1.5 cases of abuse per 100,000 patients in
the European experience).

Thus, the Drug Abuse Advisory Committee recommended that tramadol
not be "scheduled," subject to a strict postmarketing
surveillance program to be administered by an independent steering
committee, said Theodore Cicero, PhD, of Washington University
School of Medicine, who heads the steering committee.

"This was viewed jointly by the FDA and the sponsor [Ortho-McNeil
Pharmaceutical] as an experiment," Dr. Cicero said at a symposium
held in conjunction with the 8th World Congress on Pain. He added
that the company is required to state in its advertising that
tramadol has "low abuse, not no abuse potential."

Proactive Methods

Although the independent steering committee receives all notices
of adverse event reported to the sponsor and the FDA, it is also
using more proactive methods of gathering data.

In cooperation with the National Institute on Drug Abuse (NIDA),
the committee has established relationships with all NIDA grant
holders studying populations at risk. "Should they detect
abuse in their particular catchment area, they let us know immediately,"
Dr. Cicero said.

Furthermore, the committee has developed a list of 150 "key
informants," ie, people who direct methadone clinics or drug
treatment programs and "know what's going on in the street
culture," he said.


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