Pharmaceutical Drug Litigation Updates

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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B.C. woman whose daughter committed suicide sues Pfizer

Quoted from http://www.nationalpost.com/news/canada/story.html?id=2760945

B.C. woman whose daughter committed suicide sues Pfizer

Louise Dickson and Richard Watts, Canwest News Service

Published: Saturday, April 03, 2010

 

Debra Brash/Canwest News Service

Patricia Clow, with a photograph of her daughter Heidi, alleges that Pfizer were negligent in their testing, design, labelling, manufacturing and marketing of the drug Champix.

VICTORIA - A Canadian woman has launched a class-action lawsuit against the Pfizer drug company, claiming her 22-year-old daughter committed suicide after taking the prescription drug Champix to help her quit smoking.

Patricia Clow of Colwood, B.C., and two other women in British Columbia are suing Pfizer, alleging the company failed to provide adequate warning to Canadians about the potential risk of serious injury and death related to Champix. The suit also alleges Pfizer was negligent in its testing, design, labelling, manufacturing and marketing of the medication.

The claims in the lawsuit have not been proven in court.

In June, 2009, Heidi Megan Clow received a prescription for Champix. Four months later, in the early hours of Oct. 4, 2009, without showing any signs of depression, according to her mother, Heidi committed suicide by taking an overdose of painkillers.

"I would like to see it taken off the shelves," said Patricia Clow. "And at the very least, I would like to educate people about the risks."

Heidi wanted to be as healthy as possible, said her mother. "She was changing everything in her life. She had lost weight and was working out every day, running downtown, reading all the packaging on everything she ate or drank. And quitting smoking was part of that."

Ms. Clow insists her daughter wasn't depressed on the evening of Oct. 3, the last time she saw her alive.

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Lawsuits claim harm from Pfizer quit-smoking drug

Quoted from http://www.reuters.com/article/idUSN1417747120100115?type=marketsNews

Lawsuits claim harm from Pfizer quit-smoking drug

Thu Jan 14, 2010

By Bill Berkrot and Ransdell Pierson

NEW YORK, Jan 14 (Reuters) - Three personal injury lawsuits were filed against Pfizer Inc (PFE.N) 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."

Doubts on suicide-anti-smoking drug Chantix link

Quoted from http://www.reuters.com/article/healthNews/idUSTRE59144920091002?feedType=nl&feedName=ushealth1100

Doubts on suicide-anti-smoking drug Chantix link

Fri Oct 2, 2009 12:27pm EDT

NEW YORK (Reuters Health) - Despite earlier health agency warnings, there is no strong evidence that the anti-smoking drug Chantix raises the risk of suicidal thoughts or depression compared to other stop-smoking products, researchers reported Thursday in the British Medical Journal.

Back in July of this year, U.S. health officials ordered strong "black box" warnings be added to Chantix (also called varenicline) as well as anti-smoking drug Zyban, following more than five thousand reports of depression, hostility and other behavioral changes possibly associated with use of these drugs.

"There have been recent concerns that varenicline, a relatively new smoking cessation product, may increase the risk of suicidal behavior and suicide," study co-author Dr. David Gunnell of the University of Bristol, UK, explained in an email to Reuters Health.

"We found no clear evidence of an increased risk of self-harm or depression associated with varenicline," he said.

The findings stem from data on more than 80,660 would-be quitters in the UK who used different smoking cessation products between September 2006 and May 2008.

A total of 63,265 of these individuals used nicotine replacement products, 10,973 used Chantix, and 6,422 used Zyban, an antidepressant also called bupropion, which has been found to help smokers quit.

When researchers looked at medical records, they didn't find any evidence of an increased risk of serious mental health problems (i.e., self-harm, suicidal thoughts or depression) while they were using these products and during the three months after the last prescription was filled.

Gunnell cautioned, however, that based on the size of the study, it's still possible that Chantix does increase the risk of suicide - or even decrease it.

"Other studies should be undertaken to provide further evidence on this issue," he concluded.

The study was funded by a grant from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

SOURCE: British Medical Journal, online October 2, 2009.

Chantix, Zyban must carry depression warning

Quoted from http://www.msnbc.msn.com/id/31685329/ns/health-addictions/

Chantix, Zyban must carry depression warning

FDA to require smoking cessation drugs to warn of mental health risks

Video

FDA puts two drugs on suicide watch July 1: The FDA on Wednesday warned that anyone taking Chantix and Zyban should be watched closely for signs of mental illness because of a growing number of reports of suicide among patients who take the drugs. NBC's Brian Williams reports. Nightly News

updated 7:25 p.m. ET, Wed., July 1, 2009

NEW YORK - The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.

The new requirement, called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA. The study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side effects, Pfizer officials said.

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