이미 알려진 부작용들 중에서 특히 교통 사고등과 관련된 보고가 들어옴에 따른 조취입니다. 이 원인으로 금연으로 의한 금단현상인지 약물에 의한 부작용인지에 대한 논란은 있을 수 있으나 어찌되었든, 금연을 시도하며 챔픽스를 복용하는 사람 중 일부에서는 의식의 변화나 어지러움, 근육 수축등이 있어 사고를 유발 할 수 있다고 합니다.
현재 Institute for Safe Medication Practices report 에 따른 보고는 다음과 같습니다.
사고 및 손상 (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.
시야 장애 (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.
심박 이상 (Heart rhythm disturbances)
The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have non-cardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms
발작 및 비정상적인 근육 수축과 운동 (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. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from these data.
중증도 또는 심한 정도의 피부 반응(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.
당뇨 (Diabetes)
The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified numerous cases of symptoms and laboratory tests consistent with new onset diabetes.
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.
시야 장애 (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.
심박 이상 (Heart rhythm disturbances)
The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have non-cardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms
발작 및 비정상적인 근육 수축과 운동 (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. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from these data.
중증도 또는 심한 정도의 피부 반응(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.
당뇨 (Diabetes)
The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified numerous cases of symptoms and laboratory tests consistent with new onset diabetes.
이와 같은 부작용으로 인해 탈 것을 운전하는 모든 분들, 비행기, 기차, 버스, 오토바이등을 운전하시는 경우에 챔픽스 복용에 주의가 필요합니다. 드물지만 크게 다칠 수도 있다는 것이죠. 특히 많은 사람의 안전을 책임지는 경우에는 주의가 필요하다고 합니다. 그러나 이러한 보고가 금연 보조제로써 챔픽스가 효과가 없다는 이야기는 아니며, 현재 복용하시는 분의 경우, 복용을 중단하라는 뜻이 아님을 알려드립니다.
Source :
New York Times story (One-time registration required)
Institute for Safe Medication Practices report (Free)
Chantix prescribing information (Free PDF, 영문판)
화이자 제공 챔픽스 약리 기전 및 임상 연구 결과 PDF(한글판)
관련글 :
2007/11/21 - [신약 임상 연구] - FDA, 금연 보조제 챔픽스 복용시 자살충동 주의
New York Times story (One-time registration required)
Institute for Safe Medication Practices report (Free)
Chantix prescribing information (Free PDF, 영문판)
화이자 제공 챔픽스 약리 기전 및 임상 연구 결과 PDF(한글판)
관련글 :
2007/11/21 - [신약 임상 연구] - FDA, 금연 보조제 챔픽스 복용시 자살충동 주의