Promacta® Pregnancy Registry

PROMACTA (Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP))

The PROMACTA® Pregnancy Registry is an observational pregnancy exposure study conducted in the United States to detect and record adverse events in a mother exposed to Promacta® during her pregnancy, and any adverse events observed in the neonate/infant through the first year of life.

Subjects should be registered as early in pregnancy as possible, and before any prenatal testing for congenital anomalies. Ongoing pregnancies may also be registered where exposure to Promacta® has already occurred.

Patients can be registered by calling GlaxoSmithKline directly at 1-888-483-5249 (toll-free).

GlaxoSmithKline's Promacta® Pregnancy Registry is managed at:

PROMACTA® Pregnancy Registry
GlaxoSmithKline
Global Clinical Safety and Pharmacovigilance
PO Box 13398
Research Triangle Park, NC 27709-9627
Phone: 888-825-5249
Fax: 1-919-483-5404

The Promacta® Pregnancy Registry requires that the patient must provide informed consent for participation in this registry. Measures are in place to protect patient confidentiality.

  • After the informed consent is provided, the Promacta® Pregnancy Registry provides the Pregnancy Initial Notification Form to the healthcare provider to report initial information about the pregnancy.
  • Around the patient's estimated date of delivery, the Pregnancy Outcome Form is sent to the registering healthcare provider to report on the pregnancy course and outcome.
  • Within the first year of life of the neonate/infant, a One-year Follow-up Form is sent to the child's healthcare provider to report on any adverse events.

Additional resources: