admin October 31st, 2007
Yellow Card Centre West Midlands has published re:Action number 35. PDF available here.
Topics include:
admin October 30th, 2007
On October 19, 2007, FDA was notified of the Data Safety Monitoring Board’s (DSMB) recommendation to stop patient enrollment in the aprotinin (marketed as Trasylol by Bayer, Inc.) treatment group arm of the: Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.
[...]
[the] FDA anticipates re-evaluation of the overall risks and benefits of Trasylol. This re-evaluation may result in the need to revise the labeling or other regulatory actions. Until this process has been completed, healthcare providers who are considering use of Trasylol should be aware of the risks and benefits described in the labeling for Trasylol and the accumulating data suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs.
admin October 17th, 2007
The FDA have issued a warning about pancreatitis associated with exenatide. In a review of 30 spontaneous reports of pancreatitis associated with exenatide, 27 had risks factors associated with pancreatitis, 22 patients improved on withdrawal of the drug, and a further 5 cases seemed to provoked by a change to a higher dosage. The FDA advise:
Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.
Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.
Suspected adverse drug reactions associated with exenatide can be reported in the UK to the Yellow Card scheme. As exenatide is a black triangle drug, any reactipn, no matter how trivial, should be reported.
admin October 16th, 2007
Papers
Cox AR, Kirkham H. A Case Study of a Graphical Misrepresentation: Drawing the Wrong Conclusions about the Measles, Mumps and Rubella Virus Vaccine. Drug Safety 2007; 30(10): 831-836.
Conference presentations
Cox AR, Anton C, Marriott JF, Ferner RE. The paradox of low prescribers who are high reporters: correlates of spontaneous reporting of adverse drug reactions within primary care. Drug Safety 2006; 30(10): 977-978
(To be presented at the 7th Annual Meeting of ISoP Bournemouth – UK, 21-24 October 2009)
McDowell SE, Coleman JJ, Ferner RE. Rhabomylsis and statins – an analysis of spontaneous case reports using a three-diensional classification scheme. Drug Safety 2006; 30(10): 979
(To be presented at the 7th Annual Meeting of ISoP Bournemouth – UK, 21-24 October 2009)
Ormerod S, McDowell SE, Coleman JJ, Ferner RE. Ethnic differences in the risks of adverse reactions to drugs used in the treatment of psychoses: systematic review and meta-analysis. Drug Safety 2006; 30(10): 975-976
(To be presented at the 7th Annual Meeting of ISoP Bournemouth – UK, 21-24 October 2009)
Book chapters
Layton D, Cox A. Pharmacovigilance. In: Bond C editor. Using Medicines Information. Oxford, Radcliffe Publishing 2007. p. 141-168.
Langford NJ, Cox A. Interactions between Antihypertensive Drugs and Other Medications. In: Comprehensive Hypertension. Editors: Lip GHY, Hall JE. Philadelphia, Mosby Elsevier; 2007. 1075-1086.
admin October 12th, 2007
The NPCi blog documents the recent withdrawal of lumiracoxib▼ (Prexige®) in Canada and argue that:
The concern about lumiracoxib’s▼ potential for rare but serious, even fatal liver reactions must feature in prescribing decisions about the drug, along with the increased risk of thrombotic events seen with all coxibs (note that all coxibs are now contraindicated for people with established ischaemic heart disease, cerebrovascular disease and peripheral artery disease, and individual risk assessment is appropriate for patients with risk factors for cardiovascular events)