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Mental Health Side effects have been updated for Chantix and Zyban

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Weldon Stanford

- Author, Drug Guardians

 

Chantix and Zyban are known far and wide as effective drugs in the war against stopping smoking. As particularly effective drugs, when the headline of this update first headlined, there was a lot of fear and nervousness to read the full article. The headline on the FDA’s website actually lead to some good news for a change, possibly encouraging more people to stop smoking with assistance of one of these pharmaceuticals.

A large clinical trial was conducted by the drug companies, on instruction from the FDA, to determine the risk of serious side effects on mood, behaviour, or thinking whilst taking the stop-smoking medicines Chantix and Zyban. Much to the drug companies’ joy, the side effects are lower than originally reported. This doesn’t mean that the previously reported mental health side effects are non-existent and it is important to stress that those presently being treated for mental illness such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past, should still be aware of the risk of possible side effects. However, most people who did have these side effects did not have serious consequences such as hospitalization, resulting in the confirmation that the benefits of stopping smoking outweigh the risks of these medicines.

The FDA has hence given notice that they will be removing the Boxed Warning for serious mental health side effects from both the Chantix and the Zyban drug labels. The language describing the warning for serious mental health side effects will also be removed, with warnings from the results from the most recent trial to be displayed in their stead.

The FDA did still recommend that: “Patients should stop taking Chantix or Zyban and call their health care professionals right away if they notice any side effects on mood, behavior, or thinking. Patients should also talk to their health care professionals for help and information about stopping smoking, including about whether stop-smoking medicines may help or if they have any questions or concerns about taking a medicine.”

Sources:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533517.htm

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