FDA Says new Chantix Study Weak and Warning Should Remain

FDA

Pfizer has released a new study claiming Chantix should have it’s warning removed off the label. The label was put on the smoking cessation pill in 2009 when disturbing side effects such as depression and suicide were noted by people taking the prescription. Due to the number of reports filed within the past nine years, The Food and Drug Administration wants more concrete evidence before removing the warning.

The pill was designed by Pfizer as a smoking cessation product and began being marketed in the United States in 2006. The standard 10 month review that the FDA warrants on new drugs was cut short to six, due to mild side effects and clear effectiveness. What set Chantix apart from other smoking cessation products at the time was the lack of nicotine. Chantix worked by reducing the urge and enjoyment of smoking while other products limited nicotine levels by wearing a patch or chewing gum with set amount already gauzed out.

Within the first year of approval, statements were rolling into the FDA about possible side effects of the drug Chantix. Basic side effect warnings were handed down on the drug after 260 reports. This included suicidal thoughts, depression and aggression being most common. As more reports rolled into the FDA, (500 by early 2008, including actual suicides)  they made a decision in 2009 to put a black box warning on the drug. A boxed warning issued by the Food and Drug Administration is the strongest warning generally guided by medical evidence and means it could lead to injury or loss of life. It is a black wrapping around the box.

Pfizer is requesting the box warning be removed from Chantix claiming an internal study found that the previous data might be overblown, citing patients taking other smoking cessation products face similar risks as those taking Chantix. This pill also carries side effects of sleep disturbances, vivid dreams, lack of sleep, depression and behavioral changes. The FDA warning does not state that the drug claims are false.

The FDA believes this recent study to be weak and missing a lot of data. Investigators said, “Clinical coding was inaccurate because Pfizer used another smoking cessation drug with the same mental side effects.” More clinical trials would have to be performed. Pfizer used 80,000 people in five studies with 11 different investigations.

Some public safety groups are now pushing The Food and Drug Administration to add additional warnings to the label that have been reported by users. Between 2013 and 2014 over a hundred reports have been filed with the FDA regarding adverse effects from the pill, including convulsions and blackouts.

The Federal Aviation Administration (FAA) banned the drug for use in pilots and air traffic controllers in 2008 after the Institute for Safe Medication Practices handed over their findings in the drug users. A full report will be out next year, listing the all findings of the trial. Until then, the FDA says the box warning should remain, adding that the previous weak study cannot be added to the labeling.

By Paul Sears

Sources:

ABC
MPR
MedPageToday
WebMD

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One Response to "FDA Says new Chantix Study Weak and Warning Should Remain"

  1. Patricia Clow   October 16, 2014 at 12:00 pm

    My daughter committed suicide while taking this poison. Of course Pfizer isn’t going to admit there is a problem. Their “testing” has been skewed to show results that put the drug in the best light. What they aren’t admitting to, is that one of their test subjects committed suicide during early testing on the drug.

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