| VARENICLINE TARTRATE | | Health Canada | 03-Jun-10 | Pfizer Canada, in collaboration with Health Canada, is advising consumers of important changes to the CHAMPIX® Product Monograph and Consumer Information section.
A "What is the most important information I should know about CHAMPIX®?"
Your healthcare provider will help decide what dose is right for you.
CHAMPIX® (varenicline tartrate) is a prescription medicine that is used in combination with supportive counselling to help motivated adults quit smoking.
Serious allergic reactions (such as swelling of the face, lips, gums, tongue and throat that can cause trouble breathing) and skin reactions (such as rash, swelling, redness, and peeling of the skin).
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| VARENICLINE | | MHRA | 07-Oct-09 | MHRA issued updates for the following drugs:
Ceftriaxone: incompatibility with calcium-containing solutions—updated advice
High-dose cyproterone acetate: potential risk of (multiple) meningiomas
Human papillomavirus (HPV) immunisation programme—first year safety review
Smoking and smoking cessation: clinically significant interactions with commonly used medicines
Aspirin: not licensed for primary prevention of thrombotic vascular disease
Varenicline and suicidal behaviour: cohort study provides some reassurance |
| VARENICLINE | | FDA | 01-Jul-09 | FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. |
| VARENICLINE TARTRATE | | Health Canada | 06-Jan-09 | Health Canada is also informing Canadians that it is in the process of further strengthening the labelling for the drug with respect to the risk of serious psychiatric adverse effects.
While Champix (the brand name for varenicline tartrate) can be an effective tool for quitting smoking when used as part of a support program, there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others.
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| VARENICLINE | | MHRA | 06-Nov-08 | MHRA has issued drug updates:
Varenicline: adverse psychiatric reactions, including depression
Tigecycline: new formulation affects compatibility
Ezetimibe and possible increased risk of cancer: results of SEAS study
Rimonabant: European suspension of marketing authorisation
Inhaled anticholinergics: recent published data for risk of death or stroke
Paracetamol use in infancy: no strong evidence for asthma link |
| VARENICLINE | | MHRA | 07-Jul-08 | MHRA has issued drug updates:
Varenicline: suicidal thoughts and behaviour
Bisphosphonates: atrial fibrillation
Inhaled products that contain corticosteroids
Rotigotine patches: new prescribing and storage requirements
Enoxaparin (Clexane) contamination: latest information
Ergot-derived dopamine agonists: new warnings and contraindications
Etoricoxib: new prescribing guidelines
Recombinant human erythropoietins: new warning for use |
| VARENICLINE TARTRATE | | Health Canada | 20-Jun-08 | Pfizer Canada in collaboration with Health Canada would like to notify healthcare professionals of important safety information regarding CHAMPIX, and post-marketing reports of serious neuropsychiatric adverse events, including depressed mood, agitation, hostility, changes in behaviour, suicidal ideation and suicide, as well as worsening of pre-existing psychiatric illness (previously diagnosed or not).
All patients attempting to quit smoking with CHAMPIX, their families and caregivers should be alerted about the need to monitor for symptoms of neuropsychiatric adverse events.
Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.
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| VARENICLINE | | FDA | 16-May-08 | FDA informed healthcare professionals and patients that as the Agencyâ¬(TM)s review of Chantix safety data has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.
Prescribing information for Chantix was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available.
If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking Chantix and contact their healthcare professional.
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product.
There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery.
FDA is currently reviewing these cases, along with other recent reports.
A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.
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.
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| VARENICLINE | | MHRA | 04-Feb-08 | MHRA has issued drug updates:
Statins: class effects identified
Varenicline: safety update
Carisoprodol and meprobamate: risks outweigh benefits
Duphaston/Duphaston HRT (dydrogesterone): withdrawal of Marketing Authorisation
Herbal safety news: OSAS (intensive body lotion with aloe vera) found to contain steroids
Rosiglitazone: new contraindications and warnings |
| VARENICLINE | | FDA | 01-Feb-08 | FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix.
These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.
While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking.
In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.
See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients.
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