The US Food and Drug Administration (FDA) has recommended removing certain warning statements and modifications of the instructions for the use of over-the-counter (OTC) nicotine replacement therapy (NRT) products.
Commending FDA recommendation, GlaxoSmithKline (GSK) Consumer Healthcare said the action would be a positive step to help smokers to quit smoking and it will work with the FDA and implement the changes on the product labeling as soon as possible.
FDA said that there is no significant safety risk associated with the concomitant use of NRT products, with other nicotine containing products.
There is no significant safety risk associated with the use of NRT products for longer than the labeled 12 weeks of use, according to the Agency.
FDA concluded that the currently marketed NRT products do not appear to have significant potential for abuse or dependence.
The recommendations were based on the extensive and reassuring safety and efficacy research on over-the-counter NRT, like Nicorette and NicoDerm CQ.
