FDA urged to approve painkilling lollipops
Drug candy would benefit cancer patients

By PAUL RECER, Associated Press

GAITHERSBURG, Md. A raspberryflavored lollipop loaded
with narcotic painkiller for treatment of cancer patients
was recommended for federal approval Wednesday, despite
concerns about accidental poisoning of children.

A Food and Drug Administration advisory panel voted
unanimously that the benefit to cancer patients from the
painkilling candy far outweighed the risk of young children
being harmed.

"Some kid, somewhere, somehow is going to do this (eat the
lollipop)," said Suzanna Brown, a Portland, Ore., nurse and
a member of the panel. "But do we deny this benefit to
cancer patients for that reason?"

FDA approval is required before the lollipop can be sold,
but the agency generally follows the recommendations of
advisory committees.

The lollipop, called Actiq, is to be manufactured by Anesta
of Salt Lake City and marketed in partnership with Abbott
Laboratories. It is to be available only with a doctor's
prescription.

The drug is actually a sugarbased lozenge on a stick. It is
loaded with fentanyl citrate, a narcotic commonly used in
other forms to treat cancer pain. The lollipop is an off
white color, and the stick bears a large "Rx" mark.

Anesta officials said the product is designed to be
unattractive to children and is packaged in a foil pouch
that studies showed could not be opened by children up to
age 4.

Along with the packaging, the company said it was lowering
the danger of abuse of the drug by limiting and strictly
controlling distribution.

Actiq is designed for cancer patients who already are
receiving opiates to control chronic pain. The lollipop will
be used for quick relief from what is called "breakthrough
pain," sudden spasms of pain so severe that they break
through the roundtheclock dosage used to control pain.

Steven Shoemaker of Anesta said the company recognized the
attraction the lollipop might have for children and has
designed an extensive program of education, careful
distribution and patient instructions to lower the risk of
poisoning.

Asked what would happen if a child did consume the lollipop,
Shoemaker admitted: "The consequences would be life
threatening. There is a definite risk."

But members of the committee generally said the benefits to
some 1 million cancer sufferers who are in constant pain
outweighed the risk.

The lollipop will provide almost immediate relief, the
company said, for patients suddenly racked by terrible pain
from their cancer. The drug is absorbed in the mouth and
starts work within minutes. Its effects last for only about
15 minutes, but that is usually long enough to relieve
breakthrough pain.

Pain in cancer is a major problem, particularly since most
cancer patients are treated at home and often must manage
their own discomfort, said Mary Simmonds of the American
Cancer Society.

"There currently is no comparable product without a needle,"
said Simmonds of the lollipop.

Dr. Laura McNicholas of the Philadelphia Veterans Affairs
Medical Center warned the committee of a serious risk of
drug abuse from marketing the lollipop.

"My nightmare is that college kids will be out there having
a lollipop party, and some of them will not wake up in the
morning," she said.

Shoemaker said the drug would be carefully monitored and if
abuse is reported the company will "send in a SWAT team" to
investigate the problem and take measures to prevent the
illegal distribution.

Anesta and Abbott already are marketing a narcotic lollipop
that is used only in hospitals. It is for both children and
adults and is used just prior to painful medical procedures.