Chantix Heart Problems Draw FDA Warning
This week, the FDA warned that some users of the stop-smoking drug Chantix may face an increased risk of heart attacks and other heart problems. Chantix has already been linked to an increased risk of a number of potential health problems, and the lawyers at Saiontz & Kirk, P.A. are also reviewing potential Chantix heart attack lawsuits, in addition to claims on behalf of individuals who have committed suicide or suffered a severe injury from a suicide attempt or unusual, aggressive behavior.
In a drug safety communication issued on Thursday, the FDA indicated that new warnings about the risk of heart problems will be added to the Chantix label and medication guide. According to the federal regulators, individuals with pre-existing cardiovascular disease may face an increased risk of various cardiovascular events, such as:
- Heart Attack
- Angina Pectoris
- Coronary Revascularization
- Peripheral Vascular Disease
The FDA issued the warning after reviewing data from a clinical trial involving 700 smokers, half of whom were given Chantix instead of a placebo to help them quit smoking. Researchers found that 2% of the users of Chantix suffered a heart attack within a year, twice as many as smokers given a placebo, among the other heart problems.
In addition to updating the warning label, Pfizer has been required to conduct a large, combined meta-analaysis of clinical trial data that has been available to them for some time to further evaluate the risk of heart problems from Chantix.
The Institute for Safe Medicine Practices first raised concerns about heart attacks with Chantix use about three years ago. The group identified about 224 reports of Chantix heart problems among adverse events reported to the FDA between May 2006 and December 2007, the first 18 months the drug was on the market. This included reports classified as cardiac rhythm disturbances, heart attacks and other cardiac problems.
The FDA indicates that they are continuing to review and evaluate the risk of Chantix heart side effects and will provide further information in the future. In the meantime, they have asked doctors to weigh the benefits of Chantix in helping people quit smoking against the potential risk of heart problems when deciding whether to use the drug among smokers with cardiovascular disease.
CHANTIX HEART LAWSUITS
When Chantix was first introduced in 2006, the drug maker had high hopes that the medication would become a huge blockbuster. However, concerns about health problems from Chantix have already limited the use of the medication, making it a moderate-sized seller with about $800 million in sales. Concerns about the Chantix heart attack risk is likely to further deteriorate the number of users who will choose to turn to the prescription medication over other methods to help them stop smoking.
Nearly every user of Chantix is looking to quit smoking to improve their health and reduce the risk of heart problems. However, Pfizer failed to adequately warn that Chantix side effects may actually raise the risk of heart attacks for some of these people. As a result compensation may be available through a Chantix lawsuit.
To review a potential claim for a heart attack or other heart problem that occurred after using Chantix, request a free consultation and claim evaluation with our Chantix lawyers.