Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) postmarket reviews have identified serious adverse reactions that have resulted in death of newborns associated with the use of ceftriaxone and calcium salt in the body. Ceftriaxone is often used in infants between 4 and 8 weeks of age who have a high fever and are admitted to the hospital.

To date, the FDA has received seven case reports of serious cardiopulmonary adverse events in neonates, or newborns, associated with prescription of a ceftriaxone-calcium salt in the lung and/or kidneys. Five of the seven infants were preterm, and six of the group died. All events were reported in Europe. All the infants who experienced adverse events were aged 2 months and younger and were treated with ceftriaxone for a variety of infections.

As a result, the manufacturer and the FDA issued a warning to health care professionals and revised the product labeling for the potential risk of concurrent administration of ceftriaxone and calcium. Ceftriaxone is marketed as Rocephin as well as by generic brands.

Ceftriaxone is an injectable medicine that has served as a valuable agent in the treatment of meningitis. It was approved by the FDA in 1984. In 2007, the FDA issued an alert to health care professionals warning that ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.

The FDA has subsequently published more detailed information on the reported neonatal cases in medical literature, including updating recommendations based on additional in vitro data on the ceftriaxone/calcium interaction in adult and neonatal plasma, an ongoing analysis of reported cases, and a continuing safety review of data from the FDA’s AERS database.

Health care professionals are advised to report patients who have adverse events following ceftriaxone administration to the FDA’s MedWatch program.

This entry was posted on Saturday, December 5th, 2009 at 7:00 am and is filed under News, product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.