路透社报道，美国食品药品监督管理局（FDA）称，罗氏公司的器官排斥药骁悉（CellCept）会增加胎儿先天缺陷和早期（头3个月）妊娠流产的风险。

FDA将在标识上添加黑框警告，提示该药会导致外耳和面部异常（包括唇裂和腭裂），以及四肢、心脏、肾脏、食道畸形等（路透社10月29日）。FDA引用了美国移植妊娠登记处于2006年12月发布的关于24名孕妇使用CellCept的数据。 这些妇女总共33次怀孕，其中15次流产，18例产下婴儿，但是18名婴儿中4例出现了先天性缺陷。从罗氏公司搜集的上市后数据显示，77名服用CellCept的妇女中，25人出现流产，14名胎儿和婴儿有先天性缺陷，其中6名是耳畸形（Corbett Dooren, Dow Jones, 10/29）。

另外FDA称，众所周知该药的成分为霉酚酸酯，会降低血液中口服避孕药所含的激素水平，降低避孕药效果。FDA表示，在开始使用CellCept治疗的前1周，可能受孕的妇女血液或尿检妊娠应为阴性，使用该药前需要接受避孕药咨询，同时采取有效的避孕措施(AP/Google.com, 10/29)。

对此，罗氏公司给临床医生发出了建议信，解释这种新的风险警告(Dow Jones, 10/29)。根据FDA的报告，此药在应用于人类前的试验期间就已经出现了胎儿缺陷的征兆(路透社，10/29)。

Roche's Organ-Rejection Drug CellCept Increases Risk Of Birth Defects, Miscarriage, FDA Says
　　FDA on Monday said Roche's organ-rejection drug CellCept increases the risk of birth defects and miscarriage during the first trimester of pregnancy, Reuters reports. CellCept prevents organ rejection among kidney, liver and heart transplant recipients.

FDA issued a new black box warning to the drug's label about the increased risk of ear and facial deformities -- as well as problems in limbs, the heart and other organs -- among fetuses and infants exposed to the drug (Reuters, 10/29). FDA cited National Transplantation Pregnancy Registry data published in December 2006 of 24 women who were exposed to CellCept.

In addition, FDA said the drug, which is known generically as mycophenolate mofetil, might lower blood levels of the hormones in oral contraceptives, making the pills less effective at preventing pregnancy. FDA said women of childbearing age should have a negative pregnancy test within one week before beginning treatment with CellCept, receive birth control counseling and use effective contraception (AP/Google.com, 10/29).