FDA warning: TriCitrasol may cause death
The Food and Drug Administration has issued an urgent warning to all hospital pharmacies and hemodialysis units that triCitrasol (Cytosol Laboratories), an unapproved product that is used to keep bloodlines open, may cause death when infused into patients. One patient died of cardiac arrest shortly after triCitrasol, a 46.7% concentration of sodium citrate anticoagulant, was injected full strength into the hemodialysis permanent blood access catheter that had just been implanted.
The FDA is reviewing other incidents that may involve triCitrasol in the hemodialysis setting and is recommending that alternative 4% solutions of citrate be used in that and other medical settings. More information on this issue can be viewed in an FDA Talk Paper on-line at www.fda. gov/bbs/topics/ANSWERS/ANS01009.html.
Class action suit filed over Rezulin
Was this drug on the market too long?
A nationwide class action lawsuit was filed April 17 in federal court against Warner-Lambert and Parke-Davis over harmful effects suffered by patients taking Rezulin prior to its March 21 withdrawal from the market. Damages are expected to exceed $1 billion.
It is estimated that more than 1.9 million Americans took Rezulin for the treatment of type 2 diabetes during the past three years. Currently, 90 cases of hepatic failure and 63 deaths have been associated with the use of Rezulin. The lawsuit claims that the drug remained on the market too long, even after deaths and liver failure were reported.
Attorneys for the plaintiffs note that the drug was withdrawn from the European market more than a year ago. Additionally, the lawsuit claims improprieties leading to the fast-track approval of the Food and Drug Administration. Because of the allegations of conflicts of interest and contrived data from a clinical trial, the consumer group Public Citizen has called for both a criminal investigation and congressional hearings on the decision by the FDA to give Rezulin a six-month priority review.
Date set for alcohol, drug dependency school
The 49th session of the University of Utah School on Alcoholism and Other Drug Dependencies is scheduled for June 18-23 in Salt Lake City. The pharmacy section is geared toward those who are working or who desire to work in state-level programs to assist chemically dependent pharmacists and pharmacy students.
The program covers information on chemical dependency; the identification, referral, treatment, and aftercare of recovering pharmacists and pharmacy students; relapse prevention and treatment; federal and regulatory issues affecting recovering individuals; and discussion sessions for networking and exchange of information.
New Pyxis MedStation SN focuses on patient safety
Pyxis Corp. has launched a new product, MedStation SN (SafetyNet), designed to provide advanced technology, customer service, and support programs to enhance patient safety and clinical care. MedStation SN was developed to set a new standard for safe medication management by offering control, access, flexibility, and clinical information for health care providers. It integrates the Pyxis Computerized Unit-Based Inventory Exchange (Cubie); Pyxis Biometric ID; unlimited pharmacy profile interfaces; Pyxis Automated Replenishment; Cardinal Information Companies’ ALERxT Clinical Safety System; and Lexi-Comp’s On-Line Drug Reference. The station is also Cardinal ASSIST ready and is backed by on-site or Internet-based training and education programs.