- Before 1968, hemolytic disease of the newborn (HDFN) claimed the lives of 10,000 infants per year in the U.S. alone; since then, this easily preventable condition has virtually disappeared from the United States, Canada, Western Europe, and Australia thanks to the discovery and regulatory approval of Rh immunoglobulin (RhIG), also called “anti-D therapy” for human use in preventing Rh sensitization (i.e., Rh disease). Rh disease can lead to HDFN.
- Although anti-D therapy is on the World Health Organization's List of Essential Medicines, as many as 14 percent of affected fetuses are stillborn and 50 percent of live births result in neonatal death or brain injury each year in certain parts of the world.
- A November 1, 2018 gala event in Manhattan, New York, marked the 50th anniversary of U.S. regulatory approval of anti-D therapy and focused on ongoing progress in less wealthy countries in eradicating Rh sensitization and the resulting HDFN.
Losing an infant due to stillbirth may well be one of life’s most tragic experiences. Parents who have known this special kind of loss frequently go on marking the child’s would-be birthdays for years on end, wondering what might have been, grappling with a grief like no other.
A single instance of stillbirth is said to transform the life of the mother forever. Twice is unimaginable. But even more than that? Understanding this emotional terrain can belong only to women like Marilyn McCarthy, now an 81 year-old grandmother in Buffalo, New York, who endured losing four infants over a period of 11 years beginning in 1959 due to a condition later known as “Rh disease.” Yet, she, like thousands of other women in those days, received no explanation for the stillbirths that just kept on happening, over and over.
“With a stillbirth, it’s not the same when you leave the hospital,” said McCarthy. “Instead of proudly carrying your newborn home, your arms are full of flowers while you head directly to the cemetery to see where they buried your baby.”
In those days, other women, also with Rh disease, delivered infants born alive but who had profound neurological impairment at birth.
Looking Back: Epic Medical Breakthrough in 1968 Saved Countless Infants
For McCarthy, it would take years to realize that the blood of her “Baby Timothy,” “Baby Vincent,” “Baby Dennis” and “Baby Thomas” had all been Rh-positive. Her own blood is Rh-negative. (Rh, short for rhesus, refers to Rh factor, a component of blood first identified in rhesus monkeys.) That incompatibility between blood types can lead to an extremely serious and often fatal condition known as hemolytic disease of the fetus and newborn (HDFN), in which antibodies circulating in the mother’s body attack the fetus’ red blood cells. HDFN is the result of Rh sensitization or, as it is also called, Rh disease.
Indeed, in those days, HDFN was plaguing not only the McCarthys, but also about 10,000 other U.S. couples each year and others elsewhere.
It would take a medical breakthrough of epic proportions in 1968 – the discovery and subsequent FDA approval of anti-D therapy – to substantially reduce the incidence of HDFN in many areas of the world. Nowadays, anti-D, also known as RhoGAM® [Rho(D) Immune Globulin (Human)] and as other brand names in the U.S., and as IMMUNORHO® [Human anti-D immunoglobulin] and other brand names outside the U.S. – is administered at the beginning of the third trimester of pregnancy and shortly after delivery to prevent Rh sensitization.
Developed in the 1960s by Columbia University physicians, RhoGAM is still in use today.
Ultimately, the McCarthys were blessed with three children of their own and went on to enlarge their family by adopting three more boys and fostering 19 infants.
Looking Ahead: The Goal of Eradicating Rh Sensitization and HDFN in Regions of the World Where It is Still Prevalent
Although a therapeutic prevention for Rh disease already exists, this potentially devastating disorder is still commonly seen in much of the world due to a lack of awareness and education, and to a lack of access to appropriate care.
Under the auspices of Columbia University Irving Medical Center, and with support from Kedrion Biopharma, an international consortium of physicians, scientists, epidemiologists, midwives, global health advocates, and industrial partners has committed to eradicating HDFN where the need remains most dire. By initiating a series of pilot projects in underserved settings to help families now, the committee is demonstrating proof-of-principle approaches that will be scaled up in the future to serve large populations of pregnant women.
To this end, Columbia University hosted a full-day symposium on November 1, 2018, during which a roster of prominent speakers from around the world, representing multiple medical specialties and points of view, discussed these issues.
Dr. Peter Agre, the Bloomberg Distinguished Professor at the Johns Hopkins Bloomberg School of Public Health, presented the 3rd Annual John Gorman Lectureship in Transfusion Medicine as part of the symposium. Dr. Agre, who won the 2003 Nobel Prize in Chemistry for his work on aquaporin, the “plumbing system for human cells,” was also one of the individuals who first cloned and sequenced the Rh gene. The title of his November 1 lecture was: “Aquaporin water channels – from Rh to Malaria.”
Click here for more information on the November 1, 2018, event at Columbia University Irving Medical Center.
About RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)]
RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg), is a prescription medicine given by intramuscular injection that is used to prevent Rh immunization, a condition in which an individual with Rh-negative blood develops antibodies after exposure to Rh-positive blood.
If the father or baby is not conclusively shown to be Rh-negative, RhoGAM should be given to a Rh-negative mother in the following clinical situations to prevent Rh immunization:
- After delivery of a Rh-positive baby.
- Routine prevention of Rh immunization at 26 to 28 weeks of pregnancy.
- Maternal or fetal bleeding during pregnancy from certain conditions.
- Actual or threatened pregnancy loss at any stage.
- Ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus).
RhoGAM may also be used to prevent Rh immunization in Rh-negative patients after the incompatible transfusion of Rh-positive blood or blood products.
IMPORTANT SAFETY INFORMATION
RhoGAM should NOT be used if you are Rh-positive.
Be sure to tell your healthcare provider about all your medical conditions, including:
- If you have known severe allergic reactions or a severe response to human immune globulin.
- If you have experienced a serious reaction to other medicines that contain immune globulin.
- If you have an immunoglobulin A (IgA) deficiency. RhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.
- Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immune globulin products, like RhoGAM. The antibodies in RhoGAM may prevent the vaccine from working. Before you get a vaccine, tell your healthcare provider that you have received RhoGAM.
RhoGAM is made from human blood and therefore carries a risk of transmitting infectious agents such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
Reactions to RhoGAM that affect the entire body are extremely rare. However allergic responses to RhoGAM may occur. You should be observed for at least 20 minutes after administration for early signs of an allergic reaction. Signs and symptoms of an allergic reaction include itchy rash (hives), tightness of the chest, wheezing, low blood pressure and anaphylaxis (which may also include throat or tongue swelling, shortness of breath, vomiting, hives and/or lightheadedness). The most common side effects of RhoGAM are swelling, hardening, redness, and mild pain at the site of the injection. A small number of patients have noted a slight fever.
Your healthcare provider should provide you with a completed Patient Identification Card for you to retain and present to other healthcare providers. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.
Click here for the RhoGAM Full Prescribing Information
About Kedrion Biopharma
Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh-sensitization. Kedrion Biopharma Inc., the U.S. subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched US operations in 2011, but the company’s international roots stretch back several decades in the production of blood and plasma-derived products. Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.
RhoGAM is a registered trademark of Kedrion Biopharma Inc. ©2018 Kedrion Biopharma, Inc. All rights reserved. November 2018 CO-0629-00-2018.