CHANTIX® Side Effects a Health and Safety Risk For Consumers
Approved by the FDA in May of 2006, the quit–smoking medication CHANTIX®, manufactured by Pfizer, promised a new way to quit smoking. Unlike past cessation aids that use a limited release of nicotine into the body to ease cravings, CHANTIX® operates without using nicotine. CHANTIX® blocks nicotine from stimulating brain receptors so cigarettes do not give users the dopamine (a hormone in the brain that produces feelings of happiness and well-being) release they would otherwise get, making smoking less satisfying. At the same time, CHANTIX® stimulates the release of small quantities of dopamine to help decrease the desire for nicotine and ease withdrawal symptoms.
Brayton Purcell is currently reviewing new CHANTIX® cases for consideration. If you or someone you know took CHANTIX® and suffered injuries related to the serious side effects of CHANTIX®, please fill out this short form and an attorney will contact you to discuss your case.
CHANTIX®, a Shift in Smoking Cessation Therapy
On the surface CHANTIX® appeared to be leap forward in the ongoing battle of smoking cessation. Unfortunately, CHANTIX® has not been without its share of problems. In the 4th quarter of 2007 CHANTIX® accounted for 988 serious injuries reported to the FDA; more than any other medication for that time period. On February 1, 2008, the FDA issued a public health advisory concerning changes in warning labels for CHANTIX® and acknowledged the possibility of severe changes in mood and behavior in patients taking CHANTIX®. The serious side effects reported to the FDA include:
- Suicidal acts, thoughts or behaviors
- Possible psychosis, hostility or aggression
- Suicidal or homicidal ideation, paranoia or hallucination
- Death
Other side effects related to CHANTIX® can include:
- Accidents and injuries
- Vision disturbance
- Heart rhythm disturbances
- Seizures and abnormal muscle spasms
- Moderate and severe skin reactions
- Diabetes
FDA Fast Tracked Approval of CHANTIX®
The FDA utilized a short analysis period to fast track the approval of CHANTIX®. The approval was based on 6 short-term trials totaling 3,659 chronic smokers. Smokers were screened for health problems, mental stability and controlled substance usage. Pfizer’s testing procedures excluded a number of high-risk individuals within the longest trial who had the following:
- Recent treatment for depression, bipolar disorder, psychosis or panic disorder.
- Experienced clinically significant allergic reactions to any drug.
- Having any abnormal laboratory findings.
- Cardiovascular disease within six months.
- Usage of over-the-counter or prescribed stimulants or diet pills.
- A history of drug, alcohol abuse or dependence.
- Prohibited concurrent use of other psychologically active drugs, including stimulants, antidepressants, tranquilizers, antipsychotics, mood stabilizers, naltrexone and anticonvulsants.
These constraints produced a clean, consistent sample group for the FDA tests, a sample population that did not accurately represent typical CHANTIX® users. With over 3.5 million CHANTIX® prescriptions filled in the United States alone, a substantial increase in adverse (serious) side effects have been reported. Based on the reported side effects from real users, CHANTIX® has shown the ability to aggravate pre-existing health conditions and cause problems when combined with alcohol, anti-depressants or other psycho-active drugs.
CHANTIX® Side Effects – Patient Safety in Question
According to a study released on May 21, 2008 by the Institute for Safe Medication Practices, the most common CHANTIX® side effects reported were:
- Accidents and injuries. A total of 173 serious events described accidental injury, including 28 road traffic accidents and 77 falls, some leading to fractures of rib, facial bones, hand, ankle, spine, and lower limbs. In these cases a variety of potential causes were identified, including loss of consciousness, mental confusion, dizziness and muscle spasms.
- Vision disturbance. At least 148 reports contained medical terms indicating vision disturbances, including 68 cases described as blurred vision and 26 terms indicating transient or other forms of blindness. This reported effect could also describe a mechanism that could or did contribute to accidents and injuries.
- Heart rhythm disturbances. The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms.
- Seizures and abnormal muscle spasms or movements. Serious reported events included 86 cases of convulsions (seizures), 372 reports of a wide variety of movement disorders, including tremors, muscle spasms, twitching, tics, drooling, and motor hyperactivity.
- Moderate and severe skin reactions. Reported serious events included 338 cases of hives or swelling of the tongue, face, eyes, lips or other areas. In addition, 65 cases were classified as severe and included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.
- Diabetes. The FDA has received 544 reports suggesting varenicline (CHANTIX®) may be related to a loss of glycemic control.
- Deaths. 78 deaths were reported in which varenicline (CHANTIX®) was the principal suspect drug. While many reports contained limited detail, there were 28 reports of suicide.
The Institute for Safe Medication Practices (ISMP) report alerted smokers, physicians and the general public to the number of serious adverse reactions reported to the FDA by users of CHANTIX®. Because of potential safety issues associated with CHANTIX®, the report expressed:
“Safety concerns about the use of varenicline (CHANTIX®) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury. Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices. Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline (CHANTIX®) may not be safe to use in these settings.”
The Federal Aviation Administration (FAA) has banned CHANTIX® use for pilots and air controllers, and Federal Motor Carrier Safety Administration (FMCSA) has issued a statement requesting medical examiners not certify drivers taking CHANTIX® because of actual and potential side effects that could impact safe driving.
In May 2008, the FDA updated the warning labels and safety information for CHANTIX® in response to the significant increase in reported side effects from active users.
Defective Medical Drugs and Your Legal Rights
If you, a friend or a family member suspect that you have suffered an injury or death caused by accidental injury while using Chantix®, please contact Brayton Purcell immediately for a free consultation and claim evaluation.