트리렙탈의 부작용

2000년 1월 FDA승인받은 노바티스의 트리렙탈(oxcarbazepine)의 부작용이 추가된다고 합니다. 그 이유는 트리렙탈을 복용한 성인이나 어린이에게서 Stevens-Johnson syndrom(SJS)과 상피조직괴사등의 심각한 피부반응과 multi-organ hepersenistivity 반응(발열, 발진..)등이 나타났기 때문입니다. 매우 드물기는 하지만 사망 등 생명을 위협하는 정도의 심각성을 가진답니다. 심각한 피부반응은 인구100만명 당 0.5-6명의 발생건수가 보고되었고,
multi-organ hypersensitivity는 4-60명 정도입니다.

www.worstpills.org자료입니다.

Serious Skin Reactions with the Seizure Drug Oxcarbazepine (TRILEPTAL)
Worst Pills Best Pills Newsletter article June, 2005

Health professionals were notified on April 18, 2005 that the warnings had been strengthened in the professional product labeling for the seizure drug oxcarbazepine (TRILEPTAL). The notification involves serious dermatological adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that have been reported in both children and adults in association with the use of the drug. Information has also been updated regarding multi-organ hypersensitivity reactions that have been reported with the use of oxcarbazepine.
Oxcarbazepine is approved by the Food and Drug Administration (FDA) either for use alone or in combination with other seizure drugs for the treatment of partial seizures in adults and children ages 4 to 16 years of age with epilepsy. The drug was approved in January 2000. It is manufactured by the Novartis Pharmaceuticals Corporation of East Hanover, New Jersey.
The updated warning about serious skin reactions in the oxcarbazepine professional product labeling now reads:
Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with Trileptal use. The median time of onset for reported cases was 19 days. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome. Recurrence of the serious skin reactions following re-challenge with Trileptal has also been reported. The reporting rate of TEN and SJS associated with Trileptal use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3 to 10 fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million person years. Therefore, if a patient develops a skin reaction while taking Trileptal, consideration should be given to discontinuing Trileptal use and prescribing another anti-epileptic medication.
The manifestations of multiorgan hypersensitivity are variable, but may include fever and rash, accompanying a range of possible and concurrent symptoms affecting other organ systems in the body. The section in the drug’s professional product labeling on multiorgan hypersensitivity will now read:
Multi-organ hypersensitivity reactions have occurred in close temporal association (median time to detection 13 days: range 4-60) to the initiation of Trileptal therapy in adult and pediatric patients. Although there have been a limited number of reports, many of these cases resulted in hospitalization and some were considered life threatening. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included lymphadenopathy [swollen glands], hepatitis [inflammation of the liver], liver function test abnormalities, hematological [blood] abnormalities (e.g., eosinophilia, thrombocytopenia, neutropenia), pruritis [itching], nephritis [kidney problems], oliguria [reduced urine output], hepato-renal syndrome, arthralgia [pain in one or more joints] and asthenia [lack or loss of strength]. Because the disorder is variable in its expression, other signs, not noted here, may occur. If this reaction is suspected, Trileptal should be discontinued and an alternative treatment started. Although there are no case reports to indicate cross sensitivity with other drugs that produce this syndrome, the experience amongst drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.
Oxcarbazepine was approved by the FDA in January 2000. It is very similar in chemical structure to an older drug, carbamazepine (TEGRETOL), that is approved for both seizures and a painful nerve disorder know as trigeminal neuralgia. SJS and TEN have also been seen with carbamazepine and have led to deaths.
Oxcarbazepine is not a new drug. Its development began in the 1970s. It was first marketed in Denmark in 1990. Australia, France, Germany, and Sweden raised questions about the safety of oxcarbazepine that resulted in the application for approval being withdrawn from review in all of these countries.
What You Can Do
If you or a family member develop a hypersensitivity reaction or a skin rash while taking oxcarbazepine, contact the prescribing physician immediately. To report an adverse reaction to oxcarbazepine or any drug to the FDA, see the box below.