The parents of Carter Albrecht, a Dallas musician who was shot to death during a bizarre episode that was allegedly fueled by Chantix side effects, have filed suit against Pfizer, Inc. According to a CBS 11 report, the lawsuit claims Pfizer did not disclose the risks of Chantix or provide adequate warning of possible side effects when Albrecht began taking it in an effort to quit smoking.

Albrecht’s death occurred in September 2007, just a week after he began taking Chantix. Shortly after beginning Chantix therapy, Albrecht began complaining of vivid dreams. According to a Dallas Morning News article published after his death, Albrecht had lashed out violently towards his girlfriend on the night he died – something she said had never occurred before. Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht. (more…)

Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts. A Black Box Warning is the Food & Drug Administration’s (FDA) most serious safety notice.

It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning. (more…)

A direct-to-consumer (DTC) drug ad is raising some controversy over marketing of a medication that has long been surrounded with debate. Consumer Reports is questioning the ethics of a Chantix (varenicline) ad that, while never mentioning the drug by name, appears to be marketing the medication while seeming to be a public service announcement.

The commercial focuses on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presents information in a public service format, says Consumer Reports, pointing out that it is only at the end of the commercial that hints about the ad’s origin are discreetly revealed. The ad indicates, in the final moments, that it is sponsored by Pfizer, which is the maker of Chantix. Also, the MyTimeToQuit Website leads viewers to the Chantix Website. (more…)

The controversial smoking cessation drug known as Chantix in the U.S., was introduced by Pfizer as Champix nearly two years ago in Great Britain.  The drug is known generically as varenicline in both countries and, in Great Britain, about 400,000 prescriptions have been written says BBC News’ online site.  Internationally, says the BBC, about nine million prescriptions have been written.

The BBC explains that Chantix is a nicotine-mimicking drug that enables the body to reduce its urge for cigarettes while also reducing its withdrawal symptoms.  However, in studies, the drug did not provide increased efficacy over other methods of smoking cessation.  Despite this, notes the BBC, Pfizer earned over $883 million from the drug in its first year. (more…)

Reports of drug adverse events, including deaths,  increased sharply in the first quarter of the 2008, a new report says.   According to the Institute for Safe Medication Practices, the non-profit research group which compiled the report, much of the increase was due to side effects from the anti-smoking drug Chantix, as well as tainted heparin.  However, the narcotic pain reliever Oxycodone, the anti-anxiety medication Alprazolam (sold under the brand names Xanax, Reclam and Niravam) and Acetaminophen had the highest number of death reports in the same time period.

The Institute compiled its quarterly report from an analysis of  new adverse drug event reports submitted to the Food & Drug Administration (FDA) Adverse Event Reporting System. However, this reporting is voluntary, and only a small fraction of adverse drug events that occur are ever reported to FDA, or to drug manufacturers which then investigate and forward reports to the agency. The Institute’s statement on its report also cautioned that, while the sum of adverse event reports normally provides an overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described. (more…)

Reports of traffic accidents by users have prompted federal regulators to take another look at the safety information on the Chantix label.  Word of the latest Food & Drug Administration (FDA) review comes just days after a non-profit drug research group released a report that found, in the first quarter of 2008,  the FDA received more serious side effect reports for Chantix than for any other medication.

According to the report issued Tuesday by the Institute for Safe Medicine Practices, the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of this year.  The only other drug that even came close to matching Chantix during the same period was heparin  (779 side effect reports, including 238 possible deaths), which was the subject of a drug contamination scandal earlier this year. (more…)

The Associated Press (AP) is saying that the number of adverse effects, including deaths, linked to medications reported to the government has set a record in the first three months of this year; this according to a health industry watchdog group.  It seems, according to the AP, that the U.S. Food and Drug Administration (FDA) “received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths.”  The FDA data was derived from an analysis of federal data by the nonprofit Institute for Safe Medication Practices (ISMP), which reviewed data as far back as the 1990s.

Two drugs accounted for what the AP termed a “disproportionately large share of the latest reports.”  One drug was heparin, the tainted blood thinner from China that caused an international safety scandal that, according to the ISMP study, accounted for 779 reports of serious problems, including 102 deaths.  The FDA, which relies on data spanning a longer time frame, reports 238 deaths possibly linked to heparin. (more…)

A non-profit drug research organization said today that, in the first quarter of 2008,  the smoking cessation drug Chantix was the subject of more serious side effect reports than any other medication currently on the market.  According to the Institute for Safe Medication Practices, during that time period, the Food & Drug Administration (FDA) received 1001 adverse event reports – including deaths – in regards to Chantix. Researchers at the Institute said Chantix needs to carry stronger warnings about its potential risks of accidental injury and death.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. (more…)

A review of a Chantix study conducted in cooperation with the Department of Veterans Affairs (VA) has found that the VA was responsible for numerous “unacceptable failures” in ensuring safeguards for soldiers in the experiment.  The Chantix study used veterans suffering from post traumatic stress disorder (PTSD) as test subject.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. (more…)

Chantix maker Pfizer is planning to start running TV spots for the drug again this weekend, obviously hoping that furor over its possible link to suicidal behavior has died down.  Pfizer pulled Chantix TV commercials last year, as concerns over suicide and other side effects grew.  One Pfizer executive told Forbes.com that since the ads stopped running, some consumers have been under the impression that Chantix had actually been taken off of the market.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.  Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.    (more…)