UK says may strengthen SSRI bleeding warnings
03.04.04, 11:27 AM ET
Original story at forbes.com.
LONDON, March 4 (Reuters) - Stronger warnings about the risk of gastrointestinal bleeding are being considered as part of a safety review of so-called SSRI antidepressants, the UK Health Department said on Thursday.
It said strengthened warnings were being considered by the expert working group it has set up to examine the overall risk-benefit profile of selective serotonin reuptake inhibitors (SSRIs).
Drugs in this class include Eli Lilly's (nyse: LLY - news - people) Prozac and GlaxoSmithKline
Previous recommendations from the expert group led UK regulators to advise last year that most SSRIs should not be prescribed to adolescents because of an increased risk of suicidal thoughts in this age group.
The department's latest statement came in response to a report in this month's Drug and Therapeutic Bulletin which said SSRIs increase the risk of developing gastrointestinal bleeds almost three-fold.
"Product information for all SSRIs already contains warnings about the possible increased risk of bleeding, including gastrointestinal bleeding... Strengthened warnings about the risk of gastrointestinal bleeding are being considered by the SSRI Expert Working Group," the department said in a statement.
Copyright 2004, Reuters News Service