FDA Eyes Possible Risks of Pfizer’s Anti-Smoking Pill
FDA Eyes Possible Risks of Pfizer’s Anti-Smoking Pill
Posted by Jacob Goldstein
The FDA is reviewing the safety of Pfizer’s popular Anti-Smoking Pill
Chantix. The agency is studying reports submitted by Pfizer describing suicidal ideation, “occasional suicidal behavior” and other changes in behavior and mood associated with the drug. Problems seem to come on within days or weeks of starting the drug.
But it’s too soon to say whether the drug is clearly linked to psychiatric problems, the agency said in this “early communication” it issued this afternoon. The fact that people are trying to quit smoking may have something to do with the problems, the agency notes
The FDA also said it’s reviewing “a number of recent reports in the popular press and internet sites.” No word on whether they’ve stumbled on this Health Blog post, which describes not only the drug’s commercial success, but also the highly publicized death of a musician who was taking Chantix. (He was shot by a neighbor.)
The agency also said it’s reviewing reports of drowsiness in some people taking the drug, and recommended that patients taking Chantix should be careful driving until they know how the drug affects them. Patients should also tell their doctor if they have mood or behavior changes while taking the drug.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Read the complete 2007 MedWatch safety summary including a link to the FDA Early Communication Sheet about an Ongoing Safety Review regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix
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IWanttoQuitSmoking.com Hypnosis
Posted by Jacob Goldstein
The FDA is reviewing the safety of Pfizer’s popular Anti-Smoking Pill
Chantix. The agency is studying reports submitted by Pfizer describing suicidal ideation, “occasional suicidal behavior” and other changes in behavior and mood associated with the drug. Problems seem to come on within days or weeks of starting the drug.
But it’s too soon to say whether the drug is clearly linked to psychiatric problems, the agency said in this “early communication” it issued this afternoon. The fact that people are trying to quit smoking may have something to do with the problems, the agency notes
The FDA also said it’s reviewing “a number of recent reports in the popular press and internet sites.” No word on whether they’ve stumbled on this Health Blog post, which describes not only the drug’s commercial success, but also the highly publicized death of a musician who was taking Chantix. (He was shot by a neighbor.)
The agency also said it’s reviewing reports of drowsiness in some people taking the drug, and recommended that patients taking Chantix should be careful driving until they know how the drug affects them. Patients should also tell their doctor if they have mood or behavior changes while taking the drug.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Read the complete 2007 MedWatch safety summary including a link to the FDA Early Communication Sheet about an Ongoing Safety Review regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix
.
IWanttoQuitSmoking.com Hypnosis
Labels: Anti-Smoking Pill, Chantix, FDA, MedWatch, Pfizer
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