Chantix Health Risks - Abnormal Side Effects, Suicidal thoughts, aggressive and erratic behavior..
Suits allege harm from Pfizer quit-smoking drug
January 14, 2010 | Reuters
NEW YORK, Jan 14 (Reuters) - Three personal injury lawsuits were filed against Pfizer Inc on Thursday, claiming its smoking cessation drug Chantix caused attempted suicides and death.
The lawsuits, filed in New York State Supreme Court in Manhattan, claim that at the time the plaintiffs took Chantix, Pfizer did not tell doctors and patients about dangers it allegedly knew were related to the drug, including depression and thoughts of suicide.
Although Pfizer subsequently added warnings to its package insert, the law firm that filed all three lawsuits alleged the drug's label is still inadequate.
Pfizer introduced Chantix in the United States in 2006, hoping it would become a multibillion-dollar product and revive flagging profits. The drug's sales have fallen off as concerns about side effects increased.
Chantix sales fell 15 percent to $155 million in the third quarter of 2009.
Attorney Marc Grossman alleged in the lawsuits that the company "intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages of Chantix."
Grossman is with Sanders Viener Grossman LLP in Mineola, New York.
Two lawsuits claim the plaintiffs tried to kill themselves as a result of using Chantix. The third is a wrongful death lawsuit filed on behalf of Indiana resident Annette Pine, claiming she committed suicide after using Chantix.
The lawsuits seek trials by jury, punitive and compensatory damages, medical and legal expenses, and, in Pine's case, funeral expenses.
Pfizer issued a statement defending the drug, approved in some 86 countries as a smoking cessation aid.
"At all times, Pfizer has clearly communicated important information about the safe use of Chantix, which is available only with a prescription," Pfizer spokeswoman Sally Beatty said in the statement.
"We intend to vigorously defend this medicine," she said, adding that Chantix has helped many smokers to quit.
The lawsuits claim that each of the plaintiffs used the drug properly. They also claim that in each case the plaintiffs and their doctors were "not aware and through diligent efforts were not able to discover the risk of serious injury, and/or depressed mood and/or suicide associated with and/or caused by Chantix." (Reporting by Ransdell Pierson and Bill Berkrot; editing by Carol Bishopric)
... read more here
Suicide Warning Issued for 2 Anti-Smoking Drugs
July 1 , 2009 | New York Times
WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular stop-smoking drugs should be watched closely for signs of serious mental illness, as reported suicides among the drugs’ users mount.
But officials emphasized that patients should not be scared away from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curt Rosebraugh, director of a drug evaluation office at the F.D.A. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
The F.D.A. required Pfizer and Glaxo to place so-called black box warnings — the agency’s most serious caution — on the prescribing information for both drugs. Both companies will be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses.
... read more here.
Reports of serious drug reactions hit record
October 23 , 2008 | Associated Press
The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.
The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.
Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer... read more here.
Chantix Pulled from U.S. Military Base Pharmacy.
August 11 , 2008 | NewsInferno
Not letting people who are carrying rifles to take a drug that has been linked to suicide sounds like a good idea to me. - Marc Grossman .. In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food and Drug Admin.. read more here.
Sanders Firm Files Five Product Liability Lawsuits Against Pfizer on Behalf of Chantix Plaintiffs.
August 5 , 2008 | Lexis Nexis PR
Leading personal injury law firm representing families of individuals who suffered from suicidal thoughts and erratic behavior while taking popular smoking cessation drug. read more here.
Pfizer Strengthens Suicide Warning On Chantix Label
January 19 , 2008 | Pharmalot.com
The drug maker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.
You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “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 taking Chantix.”
And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.
A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.
The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency
Chantix (Varenicline)
November 20th 2007 | Food & Drug Administration
Food & Drug Administration 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.
Food & Drug Administration 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. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
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.
Safety Review
Varenicline (Chantix)
Food & Drug Administration has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.
Suicidal Thoughts
The manufacturer of Chantix, Pfizer, Inc., recently submitted to Food & Drug Administration post marketing cases describing suicidal ideation and occasional suicidal behavior. Food & Drug Administration currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites. 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. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
Aggressive and Erratic Behavior
Food & Drug Administration is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, Food & Drug Administration asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.
Drowsiness
Food & Drug Administration is evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.
Food & Drug Administration recommends the following:
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
This early communication is in keeping with Food & Drug Administration’s commitment to inform the public about its ongoing safety reviews of drugs. Food & Drug Administration is working with Pfizer, Inc., to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery. Food & Drug Administration is working to complete the analysis of the materials submitted by Pfizer. As soon as this analysis is completed, Food & Drug Administration will communicate its conclusions and recommendations to the public.
- source information: Food & Drug Administration
Chantix Defective Drug Lawsuit
The Food and Drug Administration has revealed that Chantix provoke depressed mood, suicidal ideation, and changes in emotion and behavior. It is important to notify your health care professional and monitor your progress on the drug. You should not discontinue use of the prescription before consulting your health care professional first. If you have or still are taking Chantix and want to know the eligibility of your claim contact our us right now. We can provide you with a free consultation and help you better understand your rights. It is important to retain an attorney for your case that is competent, experienced and resourceful in this type of field. Our law firm has recovered phenomenal results in the field of defective drugs, while the recent information about Chantix does not fully uncover all the side effects, our law firm is thoroughly investigating all legal as well as medical aspects of the defect. Our law firm is one of the first to file defective drug cases on behalf of our clients and we continue to receive dozens of cases daily regarding similar abnormal effects of Chantix. It is becoming more and more clear that Chantix may be linked to very serious emotional and psychological effects that can harm the person taking it. Don't wait, speak with us today regarding your experience or your loved one during Chantix treatment. Our Online, Telephone and person-to-person consultation is absolutely free. Call Us today at: 1 - 800 - FAIR - PLAY, fill out the form below or contact us directly.
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