WHO Drug Information Vol. 23, No. 1, 2009 - World Health ...

More documents

Recommendations

Info

WHO Drug Information Vol 23, No. 1, 2009Pharmacovigilance Focusso, paradoxically, may lead to boththrombus formation and haemorrhage.• Septic patients are generally treated inintensive care units but the adverseeffect reporters (if disclosed) weremostly GPs, pharmacists and otherhealth professionals, possibly notpossessing detailed information.• On consulting the WHO database, it canbe seen that other reports on drotrecoginalfa between 2002 and 2007specified various haemorrhages (thewell-known adverse effects of drotrecoginalfa), as well as 43 reports ofDIC itself.ConclusionIn 13 reports of thrombosis associatedwith the use of drotrecogin alfa, retrievedfrom VigiBase, it appears likely that thereported thrombotic events represent amanifestation of the underlying diseaseprocess (severe sepsis), rather than anadverse reaction to any administeredmedicine. This analysis underlines theimportance of considered assessment ofall reported adverse drug reactions data.References1. Goshman L. Drotrecogin Alfa, Activated.Journal of the Pharmacy Society of WisconsinMar/Apr 2002;3335.2. Sepsis.com – understanding sepsis andsevere sepsis. www.sepsis.com/family_friends/ understanding.jsp?reqNavId=5.2,downloaded 03.01.2008.3. Cada DJ, Levien T. Drotrecogin Alfa.Hospital Pharmacy 2002;37(5):511–517.4. Bernard GR, Vincent Jl, Laterre PF. Efficacyand safety of recombinant human activatedprotein C for severe sepsis. New EnglandJournal of Medicine 2001;344:699–709.5. 1974-–2207 Thomson MICROMEDEXDatabase.6. Propofol. Merck Manual. www.merck.com/mmpe/lexicomp/propofol,htm, downloaded 08.08.2008.7. GR Bernard et al. Extended evaluation ofRecombinant Human Activated Protein CUnited States Trial (ENHANCE US). Chest2004;125:2206-2216.8. Becker JU, Wira CR. Disseminated IntravascularCoagulation. www.emedicine.com/emerg/topic150.htm, downloaded 07.08.2008.9. Aysola A , Lopez-Plaza I. DisseminatedIntravascular Coagulation. www.itxm.org/TMU1998/tmu3-99.htm, downloaded07.08.2008.10. Dhainaut JF et al. Treatment effects ofdrotrecogin alfa (activated) in patients withsevere sepsis with or without disseminatedintravascular coagulation. Journal of Thrombosisand Haemostasis 2004;2(11):1924–1933.25
WHO Drug Information Vol 23, No. 1, 2009Safety and Efficacy IssuesGenetic basis ofadverse drug eventsUnited States of America — The firstdata offering health care professionals abetter look into the genetic basis ofcertain types of adverse drug events hasbeen released by the Food and DrugAdministration (FDA) and the InternationalSerious Adverse Event Consortium(SAEC). Data are focused on the geneticsassociated with drug-induced seriousskin rashes, such as Stevens-Johnsonsyndrome and toxic epidermal necrolysis,and help better predict an individual’s riskof developing these reactions.Both skin conditions appear as allergiclikeskin reactions associated with blisteringand peeling, and are considered lifethreatening.Medications causing theseserious allergic reactions should bediscontinued. If such signs and symptomsare not quickly recognized, these reactionscan be fatal.The SAEC is a non-profit partnership ofpharmaceutical companies, the WellcomeTrust, and academic institutions focusedon research relating to the genetics ofdrug-induced serious adverse events.Researchers who enter into a data useagreement can obtain free access to thedata to generate custom data inquiriesand obtain immediate results on thegenetic basis of adverse drug events.References1. FDA News, 10 February 2009. www.fda.gov2. International Serious Adverse EventConsortium at http://www.saeconsortium.orgAnaesthetic infusion with painpumps: articular chondrolysisCanada — Postoperative pain pumps areinfusion devices designed to continuouslydeliver controlled amounts of medication(1, 2). They can be used to infuse localanaesthetic solutions directly into operativesites for pain management followingsurgical procedures. The device consistsof a reservoir containing the local anaestheticsolution which is delivered bygravity or by electric pump through acatheter implanted directly into thesurgical wound. Bupivacaine is an anaestheticcommonly used with postoperativepain pumps (3). A combination ofbupivacaine and epinephrine is alsoused, with the epinephrine inducingvasoconstriction and slowing down theabsorption of bupivacaine.As of July 2008, Health Canada hasreceived 8 incident reports of articularchondrolysis following shoulder surgerythat were suspected of being associatedwith the use of postoperative pain pumps.The pain pumps were used for about 48hours after surgery. All of the patientsreceived bupivacaine with epinephrine.Chondrolysis was diagnosed betweenone month and one year after surgeryand use of the pain pumps.Chondrolysis is a progressive degenerationof the cartilage for which the cause isnot fully understood (4, 5). Chondrolysisof the shoulder results in narrowing of thejoint space, leading to pain and loss ofmotion; it is a debilitating condition thatrequires medical attention and possiblysurgery (3, 4). Chondrolysis is listedamong the possible adverse incidents inthe device labelling of pain pumps (1, 2).The device labelling states that the26
Page 2 and 3: WHO Drug Information Vol 23, No. 1,
Page 50 and 51: WHO Drug Information, Vol. 23, No.
Page 76 and 77:
WHO Drug Information, Vol. 23, No.
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84:
show all

WHO Drug Information Vol. 23, No. 1, 2009 - World Health ...

Create successful ePaper yourself

Delete template?

Save as template?