"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Ganirelix Acetate Injection
The safety of Ganirelix Acetate Injection (ganirelix) was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Ganirelix Acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of Ganirelix Acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality.
TABLE IV: Incidence of common adverse events (Incidence ≥ 1%
in Ganirelix Acetate-treated subjects). Completed controlled clinical studies
|Adverse Events Occurring in ≥ 1%||Ganirelix Acetate N=794
|Abdominal Pain (gynecological)||4.8 (38)|
|Death Fetal||3.7 (29)|
|Ovarian Hyperstimulation Syndrome||2.4 (19)|
|Vaginal Bleeding||1.8 (14)|
|Injection Site Reaction||1.1 (9)|
|Abdominal Pain (gastrointestinal)||1.0 (8)|
During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported (see PRECAUTIONS).
Ongoing clinical follow-up studies of 283 newborns of women administered Ganirelix Acetate Injection (ganirelix) were reviewed. There were three neonates with major congenital anomalies and 18 neonates with minor congenital anomalies. The major congenital anomalies were: hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome. The minor congenital anomalies were: nevus, skin tags, sacral sinus, hemangioma, torticollis/asymmetric skull, talipes, supernumerary digit finger, hip subluxation, torticollis/high palate, occiput/abnormal hand crease, hernia umbilicalis, hernia inguinalis, hydrocele, undescended testis, and hydronephrosis. The causal relationship between these congenital anomalies and Ganirelix Acetate is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, progesterone) may confound ART (Assisted Reproductive Technology) procedures.
Read the Ganirelix Acetate Injection (ganirelix) Side Effects Center for a complete guide to possible side effects
No formal drug-drug interaction studies have been performed.
Last reviewed on RxList: 8/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Ganirelix Acetate Injection Information
Ganirelix Acetate Injection - User Reviews
Ganirelix Acetate Injection User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.