Fda approves removal of boxed warning regarding serious neuropsychiatric events from chantix® (varenicline) labeling _ pfizer_ one of the world’s premier biopharmaceutical companies

Pfizer announced today that the U.S. What housing benefit can i get Food and Drug Administration (FDA) approved updates to the CHANTIX ® (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events. How do i claim housing benefit and council tax The removal of the boxed warning is based on the outcomes of EAGLES ( E valuating A dverse Events in a Gl obal Smoking C e ssation S tudy), the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder, and is consistent with the recent recommendation of the FDA Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committees. Housing benefit payments over christmas Additional labeling revisions based on EAGLES include updates to the corresponding warning regarding neuropsychiatric safety and the addition of information on the superior efficacy of CHANTIX compared to bupropion or nicotine patch. Benefit calculator housing 1,2

“For millions who smoke, stopping smoking is one of the most important steps they can take to improve their health, and Pfizer is committed to helping smokers in their quit journey,” said Freda Lewis-Hall, M.D., DFAPA, chief medical officer and EVP, Pfizer Inc. Housing benefit calculator ni “We are pleased with the FDA’s decision to update the CHANTIX labeling based on EAGLES – the largest clinical trial of smoking cessation medications – and we expect this new information may further facilitate an informed discussion about quitting with CHANTIX between smokers and healthcare providers.”

“While the benefits of quitting are immediate and substantial, few smokers are able to quit on their own and need the help of counseling and smoking cessation therapy,” said Dr. Change address housing benefit A. Apply online housing benefit Eden Evins, director, Massachusetts General Hospital Center for Addiction Medicine and William Cox Family Associate Professor of Psychiatry in the Field of Addiction Medicine, Harvard Medical School. How to apply housing benefit uk “As healthcare providers work on the front lines to help people who are struggling to quit smoking, this new labeling provides clinically relevant information on the safety and efficacy of CHANTIX to help them and their patients make informed decisions about smoking cessation treatment.”

In the U.S., smoking is the leading preventable cause of death, responsible for roughly 540,000 deaths each year. Threshold for housing benefit 3,4 Stopping smoking has significant health benefits, including reducing the risk of tobacco-related diseases such as lung cancer, heart disease, stroke, chronic respiratory disease and other conditions. Housing benefit calculator newham 5 While smoking rates have declined overall, some segments of society have not made the same progress, 6,7 including people living with mental illness, Veterans, LGBTQ and other minority communities. How to cancel housing benefit online 8-10

The updated warning in the CHANTIX labeling notes that postmarketing reports of serious or clinically significant neuropsychiatric adverse events in patients treated with CHANTIX included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Housing and council tax benefit calculator Patients attempting to quit smoking with CHANTIX should be observed for the occurrence of such symptoms and instructed to discontinue CHANTIX and contact a healthcare provider if they experience such symptoms.


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In EAGLES, in the cohort of patients without a history of psychiatric disorder, CHANTIX was not associated with an increased incidence of clinically significant neuropsychiatric adverse events in a composite endpoint comprising anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, and irritability.

In the cohort of patients with a history of psychiatric disorder, there were more events reported in each treatment group compared to the non-psychiatric cohort, and the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo: Risk Differences (RDs) (95%CI) vs. How much is housing benefit for a single person placebo were 2.7% (-0.05, 5.4) for CHANTIX, 2.2% (-0.5, 4.9) for bupropion, and 0.4% (-2.2, 3.0) for transdermal nicotine. Housing benefit calculator london The neuropsychiatric events of a serious nature were reported in 0.6% of CHANTIX-treated patients, with 0.5% involving psychiatric hospitalization. Council housing benefit calculator In placebo-treated patients, serious neuropsychiatric events occurred in 0.6%, with 0.2% requiring psychiatric hospitalization.

EAGLES is a randomized, blinded, active- and placebo-controlled clinical trial, which was conducted by Pfizer in collaboration with GlaxoSmithKline at the request of and designed in consultation with the FDA and the European Medicines Agency (EMA). Housing benefit and council tax The trial is the first and largest to compare the safety and efficacy of CHANTIX, bupropion and nicotine replacement patch in approximately 8,000 smokers without and with a history of psychiatric disorder. Housing benefit christmas payments The trial was designed to compare the risk of clinically significant neuropsychiatric adverse events in patients using CHANTIX, bupropion, nicotine replacement therapy or placebo as smoking cessation aids over 12 weeks of treatment, and to determine whether smokers with a history of psychiatric disorder are at a greater risk for developing clinically significant adverse events compared to smokers without a history of psychiatric disorder. What do i need to claim housing benefit 2

CHANTIX ® (also known as CHAMPIX ® in the EU and other countries) was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults 18 and over stop smoking. Housing benefit number doncaster CHANTIX is approved in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 11 million in the U.S. Northern ireland housing benefit 11 Adults who smoke may benefit from quit-smoking support programs and/or counseling during their quit attempt. How much savings can i have to claim housing benefit 12 It’s possible that patients might slip up and smoke while taking CHANTIX. Housing council tax benefit If patients slip up, they can stay on CHANTIX and keep trying to quit. Housing benefit rules and regulations 1

Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have been reported in patients treated with CHANTIX. Housing benefit number wakefield These included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Housing benefit am i entitled Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider if they experience such adverse events.

During clinical trials and the postmarketing experience, there have been reports of seizures in patients treated with CHANTIX, with or without a history of seizures. Nil income housing benefit CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. Housing benefit houses to rent Instruct patients to discontinue CHANTIX, and contact a healthcare provider immediately if they experience a seizure while on treatment.

There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX, including unusual and sometimes aggressive behavior directed to oneself or to others and often accompanied by amnesia. Claim for housing benefit and council tax form Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol.

Cases of somnambulism have been reported in patients taking CHANTIX. How much housing benefit is a single person entitled to Some cases described harmful behavior to self, others, or property. How much housing benefit am i entitled to Instruct patients to discontinue CHANTIX and notify their healthcare provider if they experience somnambulism.

Patients should be informed that there have been reports of serious skin reactions, such as Stevens Johnson Syndrome and Erythema Multiforme and of angioedema, with swelling of the face, mouth, and neck that can lead to life-threatening respiratory compromise.

Patients should be instructed to discontinue CHANTIX and immediately seek medical care if they experience these symptoms or at the first sign of rash with mucosal lesions or any other signs of hypersensitivity.

In a meta-analysis of clinical trials including a trial in patients with stable cardiovascular disease, while serious cardiovascular events were infrequent overall, certain serious cardiovascular events were reported more frequently in patients treated with CHANTIX than placebo. Housing benefit enquiry number These events occurred primarily in patients with known cardiovascular disease. Council tax and housing benefit Instruct patients to notify their health care providers of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke.

The most common adverse reactions include nausea (30%), abnormal dreams, constipation, flatulence, and vomiting. How do i qualify for housing benefit Patients should be informed that they may experience vivid, unusual, or strange dreams during treatment with CHANTIX. Housing benefit calculator 2015 16 Patients should be advised to use caution driving or operating machinery or engaging in other potentially hazardous activities until they know how CHANTIX may affect them.

Safety and efficacy of CHANTIX in combination with other smoking cessation drug therapies have not been studied. Change of address housing benefit Dosage adjustment with CHANTIX is recommended in patients with severe renal impairment or in patients undergoing hemodialysis.

Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Claim housing benefit Dosage adjustment for these drugs may be necessary.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Apply for housing benefit We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. How much housing benefit for a couple Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Housing benefit number nottingham Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Housing benefit maximum Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Income for housing benefit For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Housing benefit allowance calculator For more information, please visit us at www.pfizer.com. Housing benefit number leeds In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of December 16, 2016. Housing benefit form northern ireland Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about CHANTIX/CHAMPIX (varenicline), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Check housing benefit claim online Risks and uncertainties include, among other things, uncertainties regarding the commercial impact of the results of the EAGLES trial and the updates to the U.S. Housing benefit online claim label for CHANTIX, including removal of the boxed warning regarding serious neuropsychiatric events; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CHAMPIX (including uncertainties regarding the impact of the EAGLES trial on the product labeling for CHAMPIX in other jurisdictions); the risk that clinical trial data are subject to differing interpretations, including by regulatory authorities; the uncertainties inherent in research and development; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Apply for housing benefit and council tax Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .