(Long Island, N.Y.) FDA announced Friday that the drug Chantix produced by Pfizer pharmaceuticals to help reduce yearnings and decrease the pleasing effects of cigarettes and other tobacco products to both moderate and heavy smokers nationwide could cause serious “Psychiatric Problems” in the future and warned the public of taking the pills without consulting a physician.
Food and Drug Administration officials said in a released statement that they have received 37 suicide cases and over 400 suicidal behavior reports that include depression, agitation and loss of sleep in connection with the drug. Chantix is taken twice a day and helps achieve smoking cessation among addicted smokers worldwide and could also serve as a substitute to other medical alternatives such as NRT’s and agonist medication. Early studies have shown that Chantix is more effective and has a greater success rate in helping smokers quit than other methods previously used and was approved for sale in the U.S. by the FDA in May of 2006. Pfizer distributed Chanitx for sale in the U.S. on Aug. 1st, 2006 and in Europe on Sep. 29th, 2006
In a statement to warn the public two weeks ago, Pfizer acknowledged the incidents in connection with their popular anti-smoking product Chantix but stressed the fact that heavy smokers who quit smoking initially experience withdrawal symptoms which share the same characteristics as those people with suicidal behavior such as mood swings and agitation.
The Food and Drug Administration refuted this statement by Pfizer in noting that they have established several cases in which patients who took the drug Chantix were experiencing psychiatric conditions even though they were still smoking. The FDA also added that patients with a history of mental conditions should warn their physicians before taking the drug as it may worsen their current condition. “There are a number of compelling cases that look like they are the result of exposure to the drug itself and not other causes, Chantix may cause worsening of current psychiatric illnesses even if it is currently under control, it may also cause an old psychiatric illness to reoccur.” said Bob Rappaport, a director at FDA’s drug evaluation center.