A batch of Indomethacin injections meant for premature babies have been recalled due to the fact that they contain particulates. These particulates are active drug and not contamination or a foreign substance. However, even though they are active drug they cannot be injected because it may provoke an immune system reaction or a microinfarct (tiny heart attacks caused by an obstruction to the arteries). This could be serious or life threatening, especially to premature babies.
The injections are used to close a condition called patent ductus arteriosus.
To sum up what this condition means, before a baby is born their aorta and pulmonary arteries are connected together by a blood vessel called the ductus arteriosus. This allows the blood from the right ventricle to bypass the baby’s lungs which are filled with fluid. After birth the vessel is not needed and it closes. In some babies this doesn’t happen, particularly if they are born prematurely or if they have Down syndrome or another heart defect. This means that the blood from the aorta and the pulmonary artery mixes and this can strain the heart and increase blood pressure in the lung arteries and can lead to congestive heart failure.
Eight of every 1,000 pre-term births results in patent ductus arteriosus. For full term infants, the rate is two in every 1,000 births. Indomethacin injections close the ductus arteriosus.
The affected lot is 1948138 and is from Bedford Laboratories. They are crediting the accounts of medical personnel who purchased the product.
If you are a parent of a patient who has received this injection and you have any questions, you can call the Professional Services Department at 800-521-5169.
You can report any adverse reactions to the U.S. Food and Drug Administration online at: www.fda.gov/medwatch/report.htm
Sources: FDA Press Release, 13th June 2011.
What Is Patent Ductus Arteriosus?, National Heart, Lung and Blood Institute, page accessed 17th June 2011
http://www.nhlbi.nih.gov/health/dci/Diseases/pda/pda_what.html
Reviewed June 17, 2011
Edited by Alison Stanton