FDA Cites Risks of Roche Laboratories' Rocephin as Rosenbaum Faria LLP Begins Research Into Infant Fatalities from Combination of Calcium and Rocephin

Manhattan law firm, Rosenbaum Faria, LLP, begins investigating the number of infant deaths associated with Roche Labs' antibiotic treatment Rocephin (ceftriaxone sodium) as the FDA issues updated Dosage and Administration requirements for the drug. The focus of the FDA update is to prevent doctors from administering Rocephin within 48 hours of calcium products to prevent adverse effects including precipitate accumulation in the lungs and kidneys and, for some infants, death.

New York, NY (PRWEB) July 13, 2007 -- In June 2007, Roche Laboratories issued a letter to healthcare professionals outlining the FDA's updated Dosage and Administration requirements for Roche's injectable antibiotic solution, Rocephin (ceftriaxone sodium).

According to the "Dear Doctor" letter, "In the past few years, isolated neonatal deaths associated with calcium-ceftriaxone precipitates in the lungs and kidneys have been described worldwide." The FDA has determined that Rocephin can displace bilirubin from its binding to serum albumin and may lead to the development of bilirubin encephalopathy causing brain damage or death.

While the research indicates the most susceptible patients are hyperbilirubinemic (a condition associated with jaundice), doctors are being warned to avoid all situations in which Rocephin is combined with calcium products. This includes the prior practice of reconstituting Rocephin with Ringers and other calcium products prior to injection, as well as the use of calcium products within 48 hours of the administration of ceftriaxone sodium.

Rocephin is typically administered to reduce the development of drug-resistant bacteria but only to treat or prevent certain infections known to be bacterial. Typical treatment is for lower respiratory tract infections, bacterial otitis media, skin infections caused by strep or staph, urinary tract infections, and pelvic inflammatory disease.

"It comes as no surprise that yet another drug is linked to the deaths of children," said Cory Rosenbaum of the Manhattan-based law firm, Rosenbaum Faria LLP. "What we have not been able to determine is the number of deaths associated with this drug."

According to Roche's own website, Rocephin is also associated with other adverse reactions including allergic pneumonitis, colitis, jaundice, palpitations, seizures, and serum sickness.

Mr. Rosenbaum also commented, "Our website is being updated to include information about Rocephin, as well as incoming information obtained from the FDA, Canadian health services, and other worldwide health services concerning the side effects and infant deaths. The public has a right to know how any drug may affect them, especially when it comes to treating their children. We will be implementing an open chat area to allow visitors to speak directly with the attorneys and paralegals at our firm about Rocephin and the other areas of law we cover."

Sources:
http://www.roche.com
http://www.medpagetoday.com/ProductAlert/Prescriptions/dh/6098
http://www.fda.gov/medwatch/safety/2007/safety07.htm

###