WHO Drug Information Vol. 20, No. 1, 2006 - World Health ...

Regulatory Action and NewsWHO Drug Information Vol 20, No. 1, 2006Cetuximab approvedfor head and neck cancerUnited States of America —The Food and DrugAdministration (FDA) has announced approval ofcetuximab (Erbitux®) for use in combination withradiation therapy to treat patients with squamouscell cancer of the head and neck (SCCHN) thatcan not be removed by surgery (unresectableSCCHN). This is the first drug approved for headand neck cancer that has shown a survival benefitin this population. Cetuximab was also approvedfor monotherapy to treat patients whose head andneck cancer has metastasized despite the use ofstandard chemotherapy.Cetuximab received a priority review and approvalwas based on a study that showed it prolongedsurvival by 20 months compared to treatment withradiation alone. Approval of monotherapy wasbased on evidence of tumor shrinkage in 13percent of patients, lasting on average of 6months.Commonly reported side effects of cetuximabwere infusion reactions (fever, chills), skin rash,fatigue/malaise, nausea. The common sideeffects associated with radiation such as soremouth, trouble swallowing, and radiation skinchanges were similar in frequency in patientsreceiving cetuximab plus radiation and thosereceiving radiation alone.Reference: FDA News, P06-34. 1 March 2006.Selegiline patch for depressionUnited States of America — The Food and DrugAdministration has approved the first transdermalpatch (Emsam®) for use in treating major depression.The once a day patch works by deliveringthe monoamine oxidase inhibitor (MAOI)selegiline. At its lowest strength, the patch can beused without the dietary restrictions that areneeded for all oral MAO inhibitors that areapproved for treating major depression.MAO inhibitors usually require specific dietaryrestrictions because when combined with certainfoods they can cause hypertensive crisis whichcan lead to a stroke and death.The only common side effect of Emsam® detectedin placebo-controlled trials was a mild skinreaction where the patch is placed. There may bemild redness at the site when a patch is removed.If the redness does not go away within severalhours after removing the patch or if irritation oritching continues, patients are advised to contacttheir doctor. Another side effect that was seenless commonly was light-headedness related to adrop in blood pressure. Like all approved antidepressants,this product carries a warning ofincreased suicidality in children and adolescents.Although the effects of heat on the patch are notknown, the drug labelling advises health careprofessionals and patients about the possibleeffects of direct heat applied to the Emsam®patch. Direct heat may result in an increasedamount of the drug absorbed from the patch.Patients should avoid exposing the patch toheating pads, electric blankets, heat lamps,saunas, hot tubs, or prolonged sunlight.Reference: FDA News, P06-31, 28 February 2006.Ketamine now a classified drugUnited Kingdom — As of 1 January 2006,Ketamine has become a controlled drug in theUnited Kingdom. This step has been takenbecause of its increasing misuse within thecountry. It is now a Class C drug, in Schedule 4part 1, under the United Kingdom Misuse ofDrugs Act, which places it alongsidebenzodiazepines, such as diazepam, etc.Reference: News & Updates. National electronicLibrary for Medicines, 3 January 2006. http://www.nelm.nhs.uk28