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Date: Sat, 20 Sep 1997 19:10:27 -0400 (EDT)
From: Iamcsquid@aol.com
Message-ID: <970920190704_1009372043@emout14.mail.aol.com>
To: ignition-point@majordomo.pobox.com
Subject: IP: NYT Science, 9/18/97

IS the FDA at it again?

All my best,

craig
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F.D.A. Panel Recommends Pain-Killing Lollipop

By THE ASSOCIATED PRESS


  GAITHERSBURG, Md. -- A raspberry-flavored lollipop loaded with narcotic
pain-killer for treatment of cancer patients was recommended today for
Federal approval, despite concerns about accidental poisoning of children. 

  A Food and Drug Administration advisory panel voted unanimously that the
benefit to cancer patients from the pain-killing candy far outweighed the
risk that young children would be harmed. 

  F.D.A. 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 Corporation of
Salt Lake City and marketed in partnership with Abbott Laboratories. 

  The drug is a sugar-based lozenge 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 the age of 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 intended for cancer patients who are already 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 round-the-clock dosage used to control pain. 

  Steven A. Shoemaker of Anesta said the company recognized the attraction
the lollipop might have for children and has developed 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, Mr. Shoemaker
said: "The consequences would be life-threatening. There is a definite risk."


  But members of the committee generally said the benefits to about 1 million
cancer sufferers outweighed the risk. 

  The lollipop will provide almost immediate relief, the company said. 



Copyright 1997 The New York Times


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