Drug Safety Developments

Alabama man's Chantix lawsuit now set to be first test case

Quoted from http://blog.al.com/spotnews/2012/10/demopolis_mans_chantix_lawsuit.html

Alabama man's Chantix lawsuit now set to be first test case

Published: Thursday, October 18, 2012, 6:35 PM Updated: Friday, October 19, 2012, 6:47 AM

By Kent Faulk | [email protected] The Birmingham News

FLORENCE, Alabama - Billy G. Bedsole Jr. began taking the smoking cessation drug Chantix in August 2007 to try and break a 34-year habit.

The 53-year-old Demopolis man, however, claims in a lawsuit that the drug triggered "insomnia, severe anxiety, severe depression, erratic behavior, suicidal ideation, and hospitalization."

Bedsole's 2009 lawsuit is among 2,635 federal lawsuits filed nationwide against Pfizer Inc. claiming that Chantix causes a variety of psychological conditions, including suicides.

n Wednesday the Bedsole lawsuit became the lead bellwether, or test case, among those federal lawsuits. The trial is slated to begin Jan. 22 in Florence before U.S. District Judge Inge Johnson.

The Bedsole lawsuit reached that status Wednesday after Pfizer agreed to a settlement with Judy Ann Whitely, a Minnesota woman who blamed her husband's 2007 suicide on his use of Chantix. The trial in that case was to have begun Monday before Johnson.

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Pfizer Resolves Chantix Product-Liability Case Ahead of Trial

Quoted from http://professional.wsj.com/article/BT-CO-20121018-710407.html

Pfizer Resolves Chantix Product-Liability Case Ahead of Trial

By Peter Loftus

Pfizer Inc. (PFE) settled a product-liability lawsuit over its smoking-cessation drug Chantix, averting what would have been the first trial in the Chantix litigation.

The lawsuit "has been amicably resolved," according to an order Wednesday dismissing the case from U.S. District Judge Inge Prytz Johnson in the northern district of Alabama.

Terms of the resolution aren't being disclosed, said a Pfizer spokesman. Attorneys for the plaintiff couldn't immediately be reached.

A trial was scheduled to begin Monday in a lawsuit brought by a Duluth, Minn., woman alleging her husband's use of Chantix caused him to commit suicide in 2007. Judy Whitely accused Pfizer of failing to properly warn of the risks before her husband, Mark, began using Chantix, and she was seeking damages. Pfizer denied the allegations.

The case is one of more than 2,600 lawsuits in federal court containing accusations that use of Chantix caused suicides or other mental-health problems.

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Judge Denies Pfizer Request for Delay in Chantix Trial

Quoted from http://www.nasdaq.com/article/2nd-update-judge-denies-pfizer-request-for-delay-in-chantix-trial-20121016-01508

Judge Denies Pfizer Request for Delay in Chantix Trial

By Peter Loftus

A federal judge denied Pfizer Inc.'s (PFE) request to delay the start of the first product-liability trial surrounding its smoking-cessation drug Chantix, a delay the company said was needed because of newly released clinical data.

New York-based Pfizer is facing more than 2,600 lawsuits in federal court containing accusations that the smoking- cessation drug Chantix caused users to commit suicide or experience other mental-health problems, and that the drug maker failed to adequately warn of these risks. Safety concerns surrounding the drug have hurt its sales growth.

The first trial is scheduled to begin Monday in federal court in Alabama, and stems from a lawsuit brought by a Duluth, Minn., woman alleging her husband's use of Chantix caused him to commit suicide in 2007. Judy Whitely accused Pfizer of failing to properly warn of the risks before her husband Mark began using Chantix, and she is seeking damages.

Pfizer has denied the allegations, arguing in court papers that there is no evidence Chantix causes suicide-related events, and that it has properly warned of the various potential risks of the drug.

Tuesday, lawyers for Pfizer filed a motion seeking to delay the trial's start until Jan. 22, because the company released results Tuesday of a clinical trial involving Chantix. The study found Chantix was more effective than a placebo in helping people with past or present depression quit smoking, and there was no difference between the drug and a placebo in measures of psychiatric health, according to Pfizer's press release.

Pfizer asked a federal judge to delay the trial "to allow all parties to complete discovery and any pre-trial motion practice" related to the new clinical data, according to a motion filed by Pfizer Tuesday.

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Pfizer Appeals Court’s Order for CEO to Testify at Trial

Quoted from http://www.bloomberg.com/news/2012-10-11/pfizer-appeals-court-s-order-for-ceo-to-testify-at-trial.html

Pfizer Appeals Court’s Order for CEO to Testify at Trial

By Margaret Cronin Fisk - Oct 11, 2012 7:43 PM ET

Pfizer Inc. (PFE) appealed a judge’s order that Chief Executive Officer Ian Read testify in person at a federal trial over claims that use of its anti-smoking drug Chantix caused a Minnesota man to commit suicide.

The family of Mark Alan Whitely sued Pfizer after his death in November 2007, alleging the company failed to sufficiently warn that Chantix could increase the risk of suicide. The Whitely lawsuit is the first of more than 2,500 Chantix cases pending in federal court in Alabama to go to trial, according to court records.

U.S. District Judge Inge Johnson ordered Read and two other company executives to testify live at the trial, which is scheduled to begin Oct. 22 in Florence, Alabama. Pfizer asked the federal appeals court in Atlanta to erase her Oct. 4 order as “plainly beyond the court’s subpoena power.”

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Federal judge sets dates for first two trials against Pfizer over Chantix stop-smoking drug

Quoted from http://blog.al.com/spotnews/2012/03/federal_judge_sets_dates_for_f.html

Federal judge sets dates for first two trials against Pfizer over Chantix stop-smoking drug

Published: Sunday, March 25, 2012, 10:45 PM Updated: Sunday, March 25, 2012, 10:56 PM

By Kent Faulk -- The Birmingham News

BIRMINGHAM, Alabama -- A federal judge in north Alabama has set dates for the first two trials to be held in thousands of civil lawsuits filed nationwide against pharmaceutical manufacturer Pfizer Inc. over Chantix, a drug to help people stop smoking.

The two lawsuits also are part of a pool of eight selected by U.S. District Judge Inge Johnson to be bellwether -- or test -- cases in the litigation. Johnson is to preside over those first trials.

 

Johnson, in a recent order, set the first case for trial on Oct. 22 in a lawsuit originally filed by Duluth, Minn., resident Judy Ann Whitely against Pfizer for the wrongful death of her husband. Mark Alan Whitely began using Chantix on Nov. 20, 2007, and he committed suicide.

As with many of the lawsuits that were filed using a standard form for the Chantix litigation, the Whitely suit does not give any details of Mark Alan Whitely's suicide, whether he had any other problems, or the date of his death. Efforts to reach the attorneys in Minnesota for Whitely were unsuccessful last week.

The next case is set for Jan. 22, 2013. In that case, a representative of the estate of Sandra Corey, of Jacksonville, Ore., is suing Pfizer for wrongful death. That lawsuit claims that Corey began using Chantix on Oct. 2, 2007, and that the drug caused depression and suicide by gunshot on July 24, 2008.

If both the Whitely and Corey cases are tried as scheduled, the third case would be one filed in 2009 by a Demopolis man, Billy Bedsole Jr., who claims he suffered insomnia, severe anxiety, severe depression, erratic behavior, suicidal ideation and hospitalization after taking Chantix.

If the first two cases are settled, dismissed or resolved, then the Bedsole case would be the first case tried, according to Johnson's order.

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New study says Chantix raises suicide risks

Quoted from http://www.reuters.com/article/2011/11/02/us-smoking-drug-idUSTRE7A181220111102

New study says Chantix raises suicide risks

By Julie Steenhuysen

CHICAGO | Wed Nov 2, 2011 5:46pm EDT

CHICAGO (Reuters) - Pfizer's smoking cessation drug Chantix carries too many risks and should only be tried when other treatments fail, researchers said on Wednesday.

Chantix was eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch, they said.

 

The findings contradict two studies released last month by the Food and Drug Administration that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged that those studies were flawed because they were too small to identify rare events and they only captured cases that were severe enough to land people in the hospital.

"Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches," said Dr. Curt Furberg, professor of Public Health Sciences at Wake Forest Baptist Medical Center, co-author of the study published online in the Public Library of Science journal PLoS One.

"The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization," Furberg said in a statement.

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Chantix: Anti-smoking drug may cause more heart attacks

Quoted from http://www.baltimoresun.com/health/bs-hs-anti-smoking-drug-20110704,0,3472281.story

Chantix may cause more heart attacks than previously thought

Hopkins study finds increased risk with anti-smoking drug

By Meredith Cohn, The Baltimore Sun

5:16 p.m. EDT, July 4, 2011

A new study led by a Johns Hopkins researcher says the popular anti-smoking drug Chantix significantly increases the risk for a heart attack or other serious heart problem in healthy, middle-aged smokers.

Dr. Sonal Singh, the study's lead author, is calling for warnings on the drug to be stronger than those currently required by the Food and Drug Administration.

"People want to quit smoking to reduce the risk of cardiovascular disease, but in this case they're taking a drug that increases the risk for the very problems they're trying to avoid," said Singh, an assistant professor of general internal medicine. The study, which said the risk increased by 72 percent for healthy, middle-aged smokers, was released Monday in the Canadian Medical Association Journal.

Singh, who reviewed 14 clinical trials, said the risk is significantly higher than the U.S. FDA indicated in mid-June when it warned about a small increase in cardiovascular impacts for those on the drug, generically known as varenicline. The FDA's warning was based on a study of 700 smokers who already had cardiovascular disease.

FDA officials responded by saying that more analysis was needed before the agency would change its position. They have also asked the drug's maker, Pfizer, to conduct another review and to plan its own study.

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Pfizer stop-smoking pill raises heart risk: FDA

Quoted from http://www.reuters.com/article/2011/06/16/us-drugs-fda-chantix-idUSTRE75F4PW20110616

Pfizer stop-smoking pill raises heart risk: FDA

WASHINGTON | Thu Jun 16, 2011 12:08pm EDT

WASHINGTON (Reuters) - Pfizer's stop-smoking drug Chantix can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular disease, U.S. drug regulators said on Thursday.

The Food and Drug Administration is changing the label for Chantix after reviewing the results of a clinical trial.

An independent randomized trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo showed that Chantix was effective in helping patients quit smoking for as long as one year.

However, patients who took the pill were also slightly more likely to have a heart attack or other adverse cardiovascular event versus patients on a placebo.

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Ala. judge preparing for anti-smoking drug suits

Quoted from http://www.bloomberg.com/news/2011-01-04/ala-judge-preparing-for-anti-smoking-drug-suits.html

Ala. judge preparing for anti-smoking drug suits

Jan 4, 2011 6:48 PM ET By The Associated Press

BIRMINGHAM, Ala. (AP) — A federal judge in Birmingham is overseeing about 1,200 lawsuits involving pharmaceutical giant Pfizer Inc. and its stop-smoking drug Chantix, many of them with smokers and their families claiming the drug left them with a variety of psychological problems, including anxiety, aggressiveness and suicidal thoughts.

In one of the lawsuits, Billy Bedsole of Demopolis, claimed he suffered memory loss, depression, mood swings and anxiety after he started taking Chantix.

"A lot of folks had a terrible reaction to the drug," said the lead plaintiffs' attorney, Ernest Cory of Birmingham.

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Report: Pfizer Failed to Test Anti-Smoking Drug Chantix on Mentally Ill

Quoted from http://www.cbsnews.com/8301-31727_162-20025743-10391695.html

Report: Pfizer Failed to Test Anti-Smoking Drug Chantix on Mentally Ill

Posted by Emily Rand

Pfizer Inc., the pharmaceutical giant that makes the smoking cessation drug Chantix, failed to test the drug on the mentally ill or those with a recent history of depression, according to a new report by Fairwarning.org.

Chantix, which helps smokers quit by suppressing the effects of nicotine on the brain, has been linked to suicidal behavior and other psychotic problems. By mid-2009, the U.S. Food and Drug Administration had received reports of nearly 100 suicides and 200 attempted suicides linked to Chantix.

The Fairwarning investigation also found that "FDA regulators approved Chantix after a speeded-up 'priority review' process, and did not request a follow-up study on mentally ill patients using the medication, even though the agency's own safety reviewer reported that the exclusion of such smokers may have undermined the clinical trials."

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