Why there is a restriction?

Just after 7 years after the US regulation took place has slapped the very strict restriction on 2 famous smoking cessation medicines, thus it has cited the risks of having a suicidal behavior. There was a big international study that has discovered no risk for the suicide. Now Chantix maker Pfizer and even Zyban maker, Glaxo SmithKline hoped that the FDA that told them to conduct a double study to get rid of the black box warnings. It will be placed on the prescription drugs because of an anecdotal patient report of having serious psychiatric side effects.

There have been warnings about the alterations in the behavior, agitation, depression, hostility and even suicidal tendencies among patients. All of the probable issues for those who want to quit without medicines made the doctors scared as the smokers try to quit. The black boxes have led the US ban against the pilots as well as the air traffic controllers that uses the Chantix that is still in effect, while the Federal Aviation Administration might reconsider it.   At the moment, the experts say that Chantix as well as Zyban is both safe to use, they are safer than smoking which will kill more than 400,000 Americans yearly.

What the Glaxo and Pfizer have to say?

Zyban was approved in 1997. It has been made available as a generic bupropion for a decade. It makes it no longer active that is being marketed by the Britain’s GlaxoSmithKline PLC. However, Chantix has approved it in 2006; it is patented until 2020 in the US, while the patent for Europe is until 2021.  If the black box warning will be removed along with other related warnings in various nations across the globe, it will be more likely to boost the sales of Chantix until some of the patents lapse and a more affordable generic replica will arrive.

Just after a few months, the companies have sent the FDA a well detailed study that results in showing the risk of some suicidal thoughts or even behavior for the patients that takes place on either drug which is quite the same for some dummy pills. That will end up being published on a Friday night by a British journal. They do believe that the available scientific information doesn’t even support some boxed warning.  They do believe that the available scientific information will not support the boxed warning. This is in accordance with the report of a psychiatrist along with Pfizer’s medical officer in an exclusive interview.

The executives of Pfizer and medicinal chemist Jotham, who happened to be the inventor of Chantix, think that it has been vindicated. He added that he is also a former smoker who also quit after his dad and uncle died of emphysema just after smoking for years. He clearly understood the hardship of quitting is there and it is a real struggle.