DATE: Tuesday, May 6, 1997                  TAG: 9705060263

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: BY LAURAN NEERGAARD, ASSOCIATED PRESS 

DATELINE: WASHINGTON                        LENGTH:   68 lines

SMOKELESS NICOTINE INHALER OK'D

Smokers trying to kick the habit are getting a new source of help: The Food and Drug Administration approved the first smokeless nicotine inhaler Monday.

The Nicotrol Inhaler, to be sold by prescription only, allows smokers to suck nicotine through a plastic tube, letting the chemical be absorbed into the body through membranes in the mouth.

The inhaler, developed by Pharmacia & Upjohn Inc. but marketed by McNeil Consumer Products, will be on pharmacy shelves later this year. McNeil said it had not yet set a price.

Now, would-be quitters can buy nicotine patches or chewing gum over the counter, or a nicotine nasal spray with a doctor's prescription.

The FDA said clinical trials showed the inhaler worked about as well as these other products. Compared to no help, McNeil said, the Nicotrol Inhaler as much as doubled the likelihood that users would abstain from smoking for a year.

Each puff of the inhaler contains eight to 10 times less nicotine than a puff of a cigarette - and none of the dangerous tar and other toxins cigarettes deliver. Also, because the nicotine is absorbed gradually through mouth tissue, users don't get the quick jolt that smokers feel when the chemical hits their lungs.

The inhaler also provides a sensation in the back of the throat similar to the feeling of inhaling a cigarette, and the ritual of bringing hand to mouth that many smokers report they miss when trying to quit, McNeil said.

However, the FDA warned that the psychological component of the Nicotrol Inhaler is not yet proved to carry any benefit.

To use the Nicotrol Inhaler, would-be quitters insert a foil-wrapped nicotine cartridge into a tube that looks like a fat, white cigarette.

Side effects include mouth or throat irritation or cough. The inhaler can be used six to 16 times a day at first, tapering off after the first three months. But it should not be used for more than six months, McNeil said.

About 46 million Americans smoke, and the government says smoking kills 400,000 a year. Surveys indicate three-fourths of smokers want to quit but have failed or are afraid to try.

In a related development, doctors are warning that nicotine patches may pose an increased poisoning hazard to children.

Fourteen children got sick after putting new or used nicotine patches on their skin or in their mouths, according to a two-year study of poison centers. The findings appear in the May issue of Pediatrics, released Monday.

Patches can retain up to three-fourths of their nicotine after use, the equivalent of four to seven cigarettes, said the authors, led by Dr. Alan Woolf of Harvard Medical School and Children's Hospital of Boston.

Sixteen million people are expected each year to buy patches, which became available over the counter in 1996. The authors urged users to keep patches out of the reach of youngsters.

Children exposed to nicotine can suffer abnormal blood pressure or heartbeat, slowed or interrupted breathing, general sluggishness, seizures and coma.

In the study, 36 children under age 16 were reported to have exposed themselves to the patches. Most of the 14 who became ill suffered nausea or vomiting, weakness, dizziness or rashes. Ten were taken to hospital emergency rooms and two were kept overnight. All recovered fully, authors said. ILLUSTRATION: Color photo

The Nicotrol Inhaler, to be sold by prescription only, allows a

smoker to take nicotine into the body through membranes in the

mouth. KEYWORDS: NICOTINE INHALER FDA DRUG

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