Thalidomide, a current teratogen in South America.
Level 4 - case-series / case-control
Case-series and birth defects registry analysis without a prospective controlled cohort.
PubMed 9098920 · doi:10.1002/(SICI)1096-9926(199612)54:6<273::AID-TERA1>3.0.CO;2-#
What was done
The Latin American Collaborative Study of Congenital Malformations (ECLAMC) evaluated birth defect surveillance data using a case-reference approach to identify post-1965 cases of thalidomide embryopathy in South American regions where thalidomide is used for leprosy treatment.
What was found
ECLAMC registered 34 cases of thalidomide embryopathy born after 1965 in leprosy-endemic areas. Among the 11 cases that were fully described, phocomelia was present in 5.
Why it matters
This demonstrates that thalidomide continues to cause birth defects in areas where it is prescribed and that surveillance programs relying solely on phocomelia will fail to capture the full spectrum of thalidomide embryopathy.
Limits
Only 11 of the 34 identified cases had complete clinical descriptions reported. The surveillance system had low population coverage, relied on retrospective detection, and could not fully assess maternal drug intake timings.
Cited by
- supports Thalidomide taken during pregnancy caused children to be born with limb reduction defects.