The Chantix label will be updated to include information on the efficacy and safety in patients with cardiovascular disease and with chronic obstructive pulmonary disease, reported the U.S. Food & Drug Administration (FDA).

The updated label includes information gathered from a randomized clinical trial of 700 smokers with cardiovascular disease. The trial revealed Chantix was effective in assisting patients with cardiovascular disease stop smoking, but it also demonstrated the smoking cessation drug is associated with a small, increased risk of certain cardiovascular adverse events. (more…)

France announced the country will no longer pay for the smoking cessation drug Champix, which is sold as Chantix in the U.S., announced Health Minister Xavier Bertran. Due to the ongoing controversy over the risks associated with Pfizer’s smoking cessation drug, the country will pull Champix from the government formulary of medicines eligible for reimbursement.

“Questions have been raised about Champix, so I’ve decided it will no longer be covered by (state) health insurance,” Bertan said. (more…)

Another Chantix lawsuit has been filed, this time by the parents of  Carter Albrecht, a Dallas Musician who was killed in 2007.  Albrecht’s parents blame Chantix side effects for their son’s death.

In July, the Food & Drug Administration (FDA) mandated that its most serious safety warning – a Black Box – regarding psychiatric side effects be included on  the Chantix label.  According to The Washington Post, the FDA said psychiatric side effects seen among Chantix users included  98 reports of suicide and 188 reports of attempted suicide.  While some of the psychiatric problems reported could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking. (more…)

The Food & Drug Administration (FDA) released a  list of  20 drugs yesterday that are currently undergoing a safety review.  Not surprisingly, the anti-smoking drug Chantix made the list.

According to Reuters, other drugs on the FDA’s list include:

• Orlistat (sold as the prescription drug Xenical, and over-the-counter as Alli) for a risk of liver injury;
• Nuvigil and Provigil for serious skin reactions that were identified as an issue with the drugs in 2007;
• Detrol for reports of Stevens-Johnson syndrome, a serious skin reaction;
• HIV drug, Sustiva due to one report of an eye-related birth defect;
• The contraceptive Yasmin, for a possible risk of pancreatitis. (more…)

A non-profit research group said that reports of drug adverse events and deaths surged during the first quarter of 2008.  Chantix and tainted heparin led the list of adverse event reports, while Oxycodone, 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 for Safe Medication Practices, the non-profit research group that compiled the report, found that in the first quarter of 2008, 10 different drugs  could be linked to 100 or more deaths  while in the previous 2 years, only 1-3 drugs accounted for 100 or more deaths. The risks of many of these drugs, like Oxycodone, Alprazolam and others, have been the subject of previous safety warnings from the Food & Drug Administration (FDA) and the Institute. (more…)

After receiving dozens of traffic accident reports involving Chantix users, the Food & Drug Administration (FDA) is reviewing the drug again to see if the safety information on its label is adequate.

The FDA has already reviewed Chantix for a possible link to suicide and suicidal behavior.  In February, the agency asked Pfizer to elevate 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 black box warning – the agency’s highest safety alert. (more…)

A report by the Institute For Safe Medicine Practices found that Chantix was the subject of 1001 adverse event reports in the first quarter of 2008 – the most attributed to any medication during that time period.

In May, researchers at the same Institute reported that Chantix had been the subject of   224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.  That study prompted the Department of Transportation, the Federal Aviation Administration and the Department of Defense to restrict the use of Chantix. (more…)

Drug companies are increasingly using marketing campaigns that leave out medication names, as well as side effect information. Drug companies like these “unbranded” ads because the Food & Drug Administration (FDA) does not require that they list safety information like side effects. Advertisements that mention a medication by name must include the reading of possible side effect. Drug company marketing execs claim that reading off side effects takes up too much time in an expensive 30 or 60 second spot. But when a drug is the subject of safety concerns, these rules can make unbranded advertising an even more attractive option for pharmaceutical companies.

Take the example of Pfizer, Inc.’s “My Time to Quit” campaign for Chantix. In the spot, a middle-age woman tells the camera, “At 6:30 in the morning, I have a cigarette. And then another on my way to work.” Viewers are then directed to Mytimetoquit.com, where they can receive information on smoking cessation. Visitors to the site find a link to a Chantix site that contains information on the antismoking drug, including the negative side effects. (more…)

One U.S. military base in Japan has decided to no longer carry Chantix because of its link to suicide and other serious side effects. The decision to remove Chantix from the pharmacy at the Yokata Air Base in Japan was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the Food & Drug Administration (FDA).

The report, which was released in May, noted that in the fourth quarter of 2007, Chantix accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period. It specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. (more…)

Chantix users in Canada – where the anti-smoking drug is sold as Champix – are being warned again that it is associated with serious side effects, including suicidal behavior. It is the second time since April that Health Canada has issued such a warning.

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…)