admin December 19th, 2006
The FDA have posted information about some fatal cases of systemic lupus erythematosus associated with rituximab:
Two patients died after being treated with Rituxan for systemic lupus erythematosus (SLE). Rituxan is approved for the above indication and is prescribed off-label for other serious diseases and conditions such as SLE. The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML) that is caused by reactivated JC virus which is present in about 80 percent of adults. Physicians should maintain a high index of suspicion for the development of PML in patients under treatment with Rituxan.
admin December 18th, 2006
The BMJ report on the HARM study, published in the Netherlands:
The hospital admissions related to medication (HARM) study found that 41 000 hospital admissions a year in the Netherlands were caused either by the incorrect use of or adverse reactions to drugs (www.nvza.nl).
These admissions accounted for 5.6% of acute admissions and were twice as likely to involve patients older than 65 years.
Almost half—19 000 admissions—were deemed “possibly avoidable” and cost the health services 85m euros (£57m; $112m) a year. They were thought to play a part in an estimated 1254 deaths a year.
This first empirical study into the safety of medicines in the Netherlands screened all acute admissions in 21 hospitals over 40 days to see whether the reasons for admissions included drug related problems.
Patients identified as being at risk were those who had failed to take their medicines properly; had reduced competence; took more than five different drugs; and had more than one medical condition, in particular kidney failure.
More information is available here.
admin December 18th, 2006
The FDA have revised the prescribing information for aprotinin (Trasylol).
FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol. The new labeling has a more focused indication, a new Warning that Trasylol administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated.
admin December 11th, 2006
re:Action 34, our occasional bulletin, has been published. The PDF is here, and back issues are here. Topics include:
Pisa syndrome: an antipsychotic dystonia
Recent changes to the Yellow Card scheme
Sharing our expertise
If you make one report this year…
Aid on NSAIDs
Lamotrigine and birth defects
Combining antithrombotics: a bleed may follow