Barbscloud

Nicotine Replacement - Yes or No?

Blog Post created by Barbscloud on Feb 1, 2020

There are many statements on this site about whether Nicotine Replacement Therapy  should be used  or not to quit smoking.   Many smoker's have used it successfully as a part of their quit plan.  I’ve used several types of NRT over the years.  Some had side effects or “tastes” I didn’t like, etc., but I’ve never become addicted to any of them.  Along with other aids, Wellbutrin, smoking cessation, and the Ex, I used nicotrol inhalers which I found extremely helpful in my current (almost) 2 year quit. 

 

So I did some research on the subject.

 

Nicotine replace aids are regulated by the FDA as are other over the counter drugs.  That means dosages and length of use have been approved by regulators.   There are actually proposals to change (expand!) some of these guidelines, but they haven’t been approved as of yet.  

"FDA's review of OTC drugs is primarily handled by CDER's (the Office of Drug Evaluation).  The Nonprescription Drug Advisory Committee meets regularly to assist the agency in evaluating issues surrounding these products."  Instructions are not arbitrary and have been reviewed not only by the FDA, but various medical sites, American Cancer Society, etc. "

Nicotine replacement is an NDA OTC drug.  "The NDA process is the route taken by manufacturers to request FDA’s approval of a new drug for sale and marketing in the U.S. 

"The goals of the OTC NDA process are to provide enough information to permit an FDA reviewer to determine: 1) whether the drug is safe and effective in its current state and whether the benefits of the drug outweigh the risks; 2) whether the drug’s proposed labeling is adequate; and 3) whether the methods used in manufacturing are adequate to preserve the drug’s identity, strength, quality, and purity."

 

 

Various recent articles (quotes) from the FDA:

 

 

 

About Nicotine Replacement Therapy (NRT)

Nicotine is the substance primarily responsible for causing addiction to tobacco products. Tobacco users who are addicted to nicotine are used to having nicotine in their bodies.

As you try to quit smoking, you may have symptoms of nicotine withdrawal. When you quit, this withdrawal may cause symptoms like cravings, or urges, to smoke; depression; trouble sleeping; irritability; anxiety; and increased appetite.

Nicotine withdrawal can discourage some smokers from continuing with a quit attempt. But the FDA has approved several smoking cessation products designed to help users gradually withdraw from smoking (that is, “wean” themselves from smoking) by using specific amounts of nicotine that decrease over time. This type of product is called a “nicotine replacement therapy” or NRT. It supplies nicotine in controlled amounts while sparing you from other chemicals found in tobacco products.

NRTs are available over the counter and by prescription. You should generally use them only for a short time to help you manage nicotine cravings and withdrawal. However, the FDA recognizes that some people may need to use these products longer to stay smoke-free. Talk to your health care provider to determine the best course of treatment for you.

Over the counter NRTs are approved for sale to people age 18 and older. They are available under various brand names and sometimes as generic products. They include:

  • Skin patches (also called “transdermal nicotine patches”). These patches are placed on the skin, similar to how you would apply an adhesive bandage.
  • Chewing gum (also called “nicotine gum”). This gum must be chewed according to the labeled instructions to be effective.
  • Lozenges (also called “nicotine lozenges”). You use these products by dissolving them in your mouth.

For over-the-counter products, it’s important to follow the instructions on the Drug Facts Label (DFL) and to read the enclosed User’s Guide for complete directions and other important information. Ask your health care provider if you have questions.

Currently, prescription nicotine replacement therapy is available only under the brand name Nicotrol, and is available both as a nasal spray and an oral inhaler. The products are FDA-approved only for use by adults.

 

While most existing NRTs have been approved for over 20 years, novel forms of nicotine delivery are being developed based on new technologies and innovations. These may develop into FDA-approved therapies that help more smokers quit.

 

Increasing access to, and use of, medicinal nicotine products to help people quit.

FDA is examining actions and working with sponsors to increase access to, and use of, FDA-approved medicinal nicotine products intended to help smokers quit. The Nicotine Steering Nicotine  held a public hearing in early 2018, which focused on Evaluating Safety and Efficacy of Nicotine Replacement Therapies (NRTs).

 

 

National Health Institute

 

9. MYTH: Nicotine replacement products are as addictive as smoking

THE FACTS: Most people using NRT products do not become dependent on them. In fact, one of the biggest problems with NRT is that people don't use enough of it for long enough. It is important to use your nicotine replacement for as long as you need to stop you going back to smoking.

Most ex-smokers are able to effectively wean themselves off NRT after the recommended 12-week course. However, for those that continue to use NRT long-term, the National Institute of Health and Care Excellence (NICE) says that ongoing use of nicotine containing products will be considerably less harmful than smoking

 American Cancer Society:

Here are some important points to think about as you decide:

  • Nicotine gums, lozenges, and inhalers are substitutes you can put into your mouth that let you control your dosage to help keep cravings under better control.
  • Nicotine gums and lozenges are generally sugar-free, but if you are diabetic and have any doubts, check with the manufacturer.
  • Nicotine nasal spray works very quickly when you need it.
  • Nicotine inhalers allow you to mimic the use of cigarettes by puffing and holding the inhaler. It also works very quickly.
  • Nicotine patches are convenient and only have to be put on once a day.
  • Both inhalers and nasal sprays require a doctor’s prescription.
  • Some people may not be able to use patches, inhalers, or nasal sprays because of allergies or other conditions.
  • Nicotine gum may stick to dentures or dental work making it hard to chew before “parking.”

Whatever type you use, take your NRT at the recommended dose, and use it only for as long as it’s recommended.

If you use a different dose or stop taking it too soon, it can’t be expected to work like it should. If you are a very heavy smoker or a very light smoker, or a smokeless tobacco user, you may want to talk with your health care provider about how to get the NRT dose that best fits your smoking history.

  So, don’t be afraid to use these products.  Decide if you wish to use them on your quit journey, which product is best for you, and follow the instructions.  Along with you doing the work and making a commitment, these products can help you achieve your goal of becoming and ex-smoker.

 

Barb

 

 

 

Outcomes