Lucentis FDA Alerts
The FDA Alert(s) below may be specifically about Lucentis or relate to a group or class of drugs which include Lucentis (ranibizumab).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for ranibizumab
Lucentis (ranibizumab injection)
Feb 1, 2007
Audience: Ophthalmological healthcare professionalsIndication: Treatment of patients with neovascular (wet) age-related macular degeneration
[Posted 02/01/2007] Genentech informed healthcare professionals of preliminary safety information from a planned interim analysis in an ongoing study (SAILOR) which confirmed the higher incidence of stroke in the 0.5 mg dose group compared to the 0.3 mg dose group (1.2% versus 0.3%, respectively; P=0.02) of patients with neovascular (wet) age-related macular degeneration who received intravitreal Lucentis. The rates of stroke for both dose groups are lower than the rates seen in the controlled clinical trials and included in the approved labeling. The planned frequency of dosing was not the same as that described in the approved labeling. This comparison was one of many made during this interim analysis.
[January 24, 2007 – Letter – Genentech]