B-15
Adverse events (AEs) among patients receiving autologous cultured chondrocytes
M. A. Malek, A. K. Mohan, J. Polder, M. M. Braun, T. R. Cote,CBER, FDA
Background: Carticel is an autologous chondrocyte product used to repair cartilaginous femoral condyle defects.
Methods: We reviewed patient demographics and anatomic site for AEs submitted to FDA Manufacturers must report AEs, however, reporting by clinicians and others is voluntary; therefore, AE reporting likely underestimates event occurrences. Moreover, AEs may be causally or only coincidentally related to the product.
Results: A total of 301 AEs among patients receiving Carticel were reported to the FDA from 1996-2003. Patients had a median age of 38 (range:13-60); 62% were male. Among the 277 reports that noted the anatomic site, 95% (264) were femoral condyles, 4% (11) were other knee sites, and 1% (2) were outside the knee. More than one AE was reported for 152 (50%) patients. AEs reported included: graft failure (25%), delamination (22%), tissue hypertrophy (18%), chondromalacia (13%), adhesions (12%), loose body (9%), meniscal tears (9%), infection (7%), and other miscellaneous complications (22% in aggregate, none exceeding 4%). There were three deaths reported: two following motor vehicle accidents and one from intracranial hemorrhage. During 8/22/97-8/22/03, Carticel was implanted in 7724 patients. During that same period, FDA received AE reports for 157 patients. Therefore, at least 2% of all Carticel treatments were followed by an AE report.
Conclusions: Most AEs described structural defects in the graft or other mechanical failures. Post marketing AE reports were similar to recognized AE's that are currently included in the product label. Given underreporting and AEs that have not yet occurred, this proportion likely underestimates event occurrences.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-JUN-24 by frf