FDA Expresses Concern Over Chantix Heart Problem Study

Chantix Study Reveals Higher Rate of Heart Side Effects

The number of heart problems in Chantix patients compared to those who took a placebo was uncommon, the FDA stated in their safety notice recently posted on their website. It was claimed that the risk of Chantix heart side effects was not a huge increase and the FDA commented by saying that even though the numbers could seem insignificant it is “more likely that it is related to the drug and not purely a chance finding.”

This latest Chantix side effect report comes on the heels of some major scrutiny of Chantix and its link to suicides among many of its users. The warning label was changed in 2011 to reflect the side effect risk of Chantix heart problems and at that time the drug manufacturer was asked to provide further evaluation of the side effect in a larger analysis and the FDA’s statements regarding the heart side effects are the result of that analysis.

The analysis indicated that of 4,190 patients, 13 of those patients were found to have experienced major Chantix cardiovascular side effects. These included both Chantix heart attacks as well as Chantix strokes. This was compared to only 6 of the 2,812 that used a placebo instead of Chantix. There were a total of 15 clinical trials that Pfizer sponsored, according to the FDA.

Although Pfizer is still claiming that the benefits of Chantix outweigh the side effect risk, many Chantix lawsuits have been filed stating the opposite.
 
Chantix Sales Continue to Rise Despite Side Effect Claims

It has been reported that Pfizer received $720 million in Chantix sales in 2011. The FDA reports that there were around 2.3 million prescriptions for Chantix in that year as well despite the growing number of Chantix lawsuits being filed for the severe side effects the anti-smoking medication has been associated with.

January 2013 marks the first federal court trial, which will be held in Florence, Alabama. This particular Chantix lawsuit claims that the medication was the cause of psychiatric disorders that resulted in the Chantix user being placed in a mental hospital. However, it is uncertain at this time whether Pfizer will try to settle the Chantix lawsuit prior to going to trial like they did in the first Chantix lawsuit that was scheduled to go to trial or not.

Chantix Side Effects

Chantix lawsuit lawyers continue to investigate a number of negative side effects linked to Chantix. These include the following:

• Changes in behavior
• Adverse behaviors including aggression,
• Psychological problems
• Depression
• Suicidal thoughts and suicide attempts
• Blackouts
• Heart Attacks
• Develop Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis
• Additional cardiovascular problems

If you or someone you know has experienced any of the negative side effects associated with Chantix, including psychological problems, aggression, depression, blackouts and suicidal thoughts, it is important to visit the Chantix Suicide, Heart Attack, Suicide Attempt & Stevens-Johnson Syndrome Class Action Lawsuit Settlement Investigation page right away. A qualified Chantix lawsuit attorney is ready to help.  Provide your information and receive a free consultation.