WHO Drug Information Vol. 24, No. 4, 2010

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Regulatory Action and NewsWHO Drug Information Vol. 24, No. 4, 2010support an increased cardiovascular riskof rosiglitazone.In view of the restrictions already in placeon the use of rosiglitazone, the Committeecould not identify additional measuresthat would reduce the cardiovascular risk.The Committee therefore concluded thatthe benefits of rosiglitazone no longeroutweigh its risks and recommended thesuspension of the marketing authorizationof the medicines.Reference: EMA Press Release, EMA/585784/2010, 23 September 2010, at http://www. ema.europa.euModified-release oral opioids:suspension of marketingauthorizationEuropean Union — The EuropeanMedicines Agency has finalized a reviewof modified-release oral opioids of theWHO level III scale for the managementof pain. The Agency’s Committee forMedicinal Products for Human Use(CHMP) concluded that the benefits ofmost of these medicines continue tooutweigh their risks, but that the existingwarnings on the interaction of thesemedicines with alcohol should be madeconsistent across the class. However, formodified-release oral opioids that containa polymethacrylate-triethylcitrate controlled-releasesystem the Committeerecommended suspension of marketingauthorization until they have been reformulatedto be more stable in alcohol.Modified-release oral opioids of the WHOlevel III scale for the management of painwere reviewed due to concerns that theymay be unstable in alcohol and that theactive substance may be released tooquickly when patients take them togetherwith alcohol. This could put patients atrisk of serious side effects such asrespiratory depression.Reference: EMA Press Release, EMA/463702/2010, dated 23 July 2010 at http://www.ema. europa.euHuman normal immunoglobulin:suspension ofmarketing authorizationEuropean Union — The EuropeanMedicines Agency has recommended thesuspension of the marketing authorizationsfor human normal immunoglobulin(Octagam®).Octagam® is an intravenous solutionused to strengthen the body’s immunesystem, including people with primaryimmunodeficiency syndrome, or childrenborn with acquired immune deficiencysyndrome (AIDS). It is also used inpeople with certain immune disorderssuch as idiopathic thrombocytopenicpurpura (ITP) and in patients who havehad a bone marrow transplant.The CHMP reviewed Octagam® becauseGermany and Sweden had suspendedthe marketing authorization of thesemedicines following an unexpectedincrease in reports of thromboembolicreactions, including stroke, myocardialinfarction and pulmonary embolism inpatients. This increase is thought to berelated to problems with the medicine’smanufacturing process.The suspension will remain in place untilthe marketing authorization holder hasrectified the problem.Reference: EMA Press Release, EMA/CHMP/591722/2010, 24 September 2010 at http://www.ema. europa.euPropoxyphene:recommendation against useUnited States of America — The Foodand Drug Administration (FDA) is recommendingagainst continued prescribing306
WHO Drug Information Vol. 24, No. 4, 2010Regulatory Action and Newsand use of the pain reliever propoxyphenebecause new data show that thedrug can cause serious toxicity to theheart, even when used at therapeuticdoses. FDA has requested that companiesvoluntarily withdraw propoxyphenefrom the United States market.Propoxyphene is an opioid pain relieverused to treat mild to moderate pain. It issold under various names as a singleingredientproduct (e.g., Darvon®) and aspart of a combination product with acetaminophen(e.g., Darvocet®).The recommendation is based on allavailable data including data from a newstudy that evaluated the effects thatincreasing doses of propoxyphene haveon the heart. FDA has concluded that thesafety risks of propoxyphene outweigh itsbenefits for pain relief at recommendeddoses.Reference: FDA Drug Safety Communication,19 November 2010 at http://www/fda.govSitaxentan: worldwidewithdrawalAustralia — The Therapeutic GoodsAdministration (TGA) has advised that thesupply of the prescription medicinesitaxentan (Thelin®) will be suspended.The company that supplies the medicinehas announced that it will withdrawThelin® from the market globally.Sitaxentan is a prescription-only medicineused to treat pulmonary hypertension.Patients currently taking sitaxentanshould contact their physician as soon aspossible to organize the supply of adifferent medicine but should not ceasetheir use of sitaxentan until they havebeen assessed and switched to anothermedication.This action has been taken in response toa review of safety data in clinical trialsthat showed patients were at risk of acuteliver failure that in some cases was notreversible. The TGA has received 10adverse event reports of abnormal liverfunction in Australian patients receivingsitaxentan.Reference: TGA Safety Alert, 10 December2010 at http://www.tga.gov.au/alerts/medicines/thelin-withdrawal.htmSibutramine: suspensionof salesSingapore — The Health SciencesAuthority (HSA) has taken a regulatorydecision to suspend the sales ofsibutramine products following a benefitriskassessment which took into considerationthe findings from the SibutramineCardiovascular Outcomes (SCOUT)study, use of the product in the localcontext and developments in otherinternational jurisdictions.Sibutramine is licensed in Singaporesince 2001 for use as an adjunctivetherapy to diet and exercise for obesepatients with a body mass index (BMI)>30kg/m 2 , or for overweight patients witha BMI >27kg/m 2 with other obesity-relatedrisk factors such as Type 2 diabetesmellitus or dyslipidaemia.The SCOUT study was a randomized,double-blind, placebo-controlled, multicentrestudy conducted in approximately10 000 patients aged ≥55 who wereobese or overweight and had a history ofcardiovascular (CV) disease and/or type2 diabetes with at least one other CV riskfactor treated over a six year period. Thestudy results showed that there was a16% increase in the risk of a primaryoutcome event of nonfatal myocardialinfarction (MI), nonfatal stroke, resuscitatedcardiac arrest and CV death in thesibutramine group as compared with theplacebo group. This was driven primarilyby increase in rates of nonfatal MI andnonfatal stroke seen in the sibutraminegroup. A review of the serious adverse307
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WHO Drug Information Vol. 24, No. 4, 2010

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