Pubdate:  Fri, 12 Sep 1997

By Alicia Ault

WASHINGTON (Reuter)  Federal drug advisers opened hearings Thursday to
help them decide whether Valium and related drugs should be more
strictly regulated or whether some restrictions should be relaxed.

The Drug Enforcement Administration (DEA) is seeking evidence from the
public, abuse experts and the Food and Drug Administration on whether it
should change how it regulates sedatives in the class known as
benzodiazepines, which includes Roche's Valium.

It started its considerations in response to a 1993 petition by
CarterWallace Inc. to take its benzodiazepine Doral (quazepam) off the
agency's list of drugs that are abused.

``Not all benzodiazepines are equal,'' CarterWallace executive James
Costin said.

There are five DEA ``schedules'' ranking drugs according to abuse
potential, with schedule I, which includes marijuana, LSD, and heroin,
being the highest.

Codeine and most barbiturates are schedule III drugs, while
benzodiazepines are schedule IV, meaning they have some abuse potential
and may cause withdrawal or psychological dependence.

At least 15 benzodiazepines are marketed in the United States, including
the popular medications Xanax (alprazolam), made by Pharmacia and
Upjohn, and Wyeth's Ativan (lorazepam).

The drugs, some of which have been on the market for 30 years, are used
to treat anxiety and panic attacks. The DEA contends that diazepam 
and more recently, alprazolam  are being widely abused.

If diazepam alone is bumped higher on the schedule, it could make the
drug appear more dangerous than competing products. It may also mean
more hassles for patients to get refills and more paperwork for
manufacturers and prescribing physicians.

Doctors who prescribe the drugs argued against singling out any of the
agents.

``Drug abuse with benzodiazepines is a rare event, almost always
occurring in patients who abuse other drugs or substances,'' said James
Ballenger, a drug abuse specialist who spoke on behalf of the American
Psychiatric Association.

``The public is prepared to think the worst about these drugs,'' he
said, noting that many patients are already anxious about the
``socalled addictive potential of benzodiazepines''.

``There is no acute crisis that brings us here,'' added David
Greenblatt, a psychiatrist at Tufts University. ``Our core understanding
of the risk of benzodiazepine treatment has not changed in the last 10
years.''

But the DEA said criminal seizures of diazepam rose from 125,000 doses
in 1995 to 344,000 doses in 1996. For alprazolam, they increased from
6,500 doses in 1995 to 10,292 in 1996.

Before acting on Carter's request or changing its regulation of
benzodiazepines, the DEA will have to weigh all the scientific evidence
and go through a rulemaking process, which could take more than a year.

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