FDA MedWatch - Flomax (tamsulosin
HCl) associated with Intraoperative Floppy Iris Syndrome
(IFIS) during phacoemulsification cataract surgery
Boehringer Ingelheim and FDA notified healthcare professionals
of revisions to PRECAUTIONS and ADVERSE REACTIONS sections
of the prescribing information for Flomax, indicated
for the treatment of the signs and symptoms of benign
prostatic hyperplasia (BPH). A surgical condition termed
Intraoperative Floppy Iris Syndrome (IFIS) has been observed
during phacoemulsification cataract surgery in some patients
treated with alpha-1 blockers including Flomax. Most
of these reports were in patients taking the alpha-1
blocker when IFIS occurred, but in some cases alpha-1
blocker had been stopped prior to surgery. It is recommended
that male patients being considered for cataract surgery,
as part of their medical history, be specifically questioned
to ascertain whether they have taken Flomax or other
alpha-1 blockers. If so, the patient's ophthalmologist
should be prepared for possible modifications to their
surgical technique that may be warranted should IFIS
be observed during the procedure.
Read the complete MedWatch 2005 Safety summary, including
links to the Dear Healthcare Professional letter and
revised prescribing information, at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Flomax