Health

FDA OKs 'Narcotic Lollipop'

November 5, 1998 / 6:15 PM EST / AP

Hundreds of thousands of cancer patients will soon have a powerful new way to fight severe pain - a raspberry-flavored "narcotic lollipop" loaded with a painkiller that can seep into the bloodstream faster than any pill.

Approved Thursday by the government, the prescription drug Actiq has been controversial because the white lozenge on a plastic stick looks somewhat like a lollipop, a word used to its manufacturer's distress. Critics fear it could entice children, with fatal consequences.

Actiq can kill children, the Food and Drug Administration warned. It even could kill adults whose bodies are not accustomed to narcotics, or it could be abused by drug addicts.

So the government made manufacturer Anesta Corp. take unusually strict steps to prevent Actiq's misuse. Among the requirements is packaging Actiq in a heavy foil that requires scissors to open, difficult for very young children. Anesta also will provide patients with free locks for the cabinets where they store Actiq, and child-resistant "fanny packs" for patients who want to keep the drug nearby.

The FDA approved Actiq despite the concerns because it provides the first way for cancer patients to control agonizing pain attacks at home. Relief can begin within minutes; only powerful drug injections usually given in hospitals work as fast.

"For the right patient, this is a very substantial improvement in the quality of ... life," said Michael Friedman, the FDA's acting commissioner and a cancer specialist. It "can provide rapid and dramatic relief."

But don't call Actiq a lollipop, Anesta officials pleaded Thursday. "It's become a very important point to us, implying it's serious medicine and not candy," said company president Thomas King. "The potency of the product shouldn't be taken cavalierly."

Actiq will not be sold until March, because Anesta needs more time to produce child-resistant packaging. Each lozenge will cost between $6 and $15.

Pain is a major problem for cancer victims. About 800,000 with chronic pain also suffer "breakthrough pain," sudden, agonizing episodes that break through the regular painkillers taken several times each day. The attacks can last up to two hours.

A man with prostate cancer that has spread to the bones, for example, might feel sudden stabbing bone pain after taking his regular medicine. Actiq, 10 times more potent than morphine, lets these patients rapidly get just the amount of medicine needed during each crisis.

It is made of fentanyl, a narcotic painkiller currently available in injections and skin patches. Putting fentanyl in a lozenge lets the drug seep through mouth tissues into the bloodstream in minutes. Patients hold the lozenge between their gums and their cheeks not under the tongue, where it's less effective until they feel relief.