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

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Regulatory Action and NewsWHO Drug Information Vol. 24, No. 4, 2010events also showed that there weresignificantly more reports of myocardialischaemia and ischaemic stroke insubjects taking sibutramine as comparedto placebo.The weight loss achieved in the SCOUTstudy was modest. At the end of 12months, the mean weight loss achievedwith sibutramine was up to 2.4 kg morethan placebo. After 12 months of treatment,no additional mean weight loss wasachieved and it was not clear if the effecton weight loss could be maintained whensibutramine was stopped.Based on these findings and the overallassessment, HSA has concluded that thebenefits of sibutramine do not outweightheir risks and has recommended that thesales of sibutramine be suspended. Thissuspension will remain in place until thecompany can provide sufficient data toidentify a group of patients for whomsibutramine’s benefits clearly outweigh itsrisks.In view of the cessation of marketing ofsibutramine in Singapore with immediateeffect, healthcare professionals areadvised to stop prescribing sibutramine,to review the therapy of existing patientswho have been prescribed sibutramineand to consider suitable alternativeswhere appropriate.Reference: HSA Safety Alert, 11 October2010 at http://www.hsa.gov.sgSibutramine-containingmedicines: withdrawalMexico — The Federal Committee forProtection against Health Risks(COFEPRIS) has requested manufacturersof products containing sibutramine tobegin withdrawal of these products fromthe market. Sibutramine is used for thetreatment of obesity and overweight.Evidence now exists of a link to cardiovascularevents.The Committee has reminded the publicof the risk incurred with self-medication ofproducts claiming weight reduction.Reference: Communication to Public andHealthcare Professionals, Comision Federalpara la Proteccion contra Riesgos Sanitarios,8 October 2010 at http://www.cofepris.gob.mxTestosterone transdermalpatch: withdrawal ofextension of indicationapplicationEuropean Union — The EuropeanMedicines Agency (EMA) has beenformally notified by the manufacturer of itsdecision to withdraw its application for anextension of indication for the centrallyauthorized testosterone transdermalpatch (Intrinsa®).On 10 August 2009, the manufacturersubmitted an application to extend themarketing authorization for Intrinsa® toinclude the treatment of hypoactivesexual desire disorder in menopausalwomen. Intrinsa® is currently authorizedfor the treatment of hypoactive sexualdesire disorder in women who have hadtheir uterus and both ovaries removed. Itis used in patients already taking anoestrogen.Reference: EMA Press Release, EMA/601877/2010, 29 September 2010 at http://www.ema. europa.euAliskiren/valsartan:withdrawal of marketingauthorization applicationEuropean Union — The EuropeanMedicines Agency has been formallynotified by the manufacturer of its decisionto withdraw the application for acentralized marketing authorization foraliskiren/valsartan (Rasival®), 150/160mg and 300/320 mg film-coated tablets.308
WHO Drug Information Vol. 24, No. 4, 2010Regulatory Action and NewsThis medicine was intended to be usedfor the treatment of essential hypertensionas a substitution therapy in adultswhose blood pressure is adequatelycontrolled with aliskiren and valsartan,given as single components concurrently,at the same dose level as in the combination.The company stated that its decision towithdraw the application was based ontheir inability to address the CHMP’srequests and provide additional datawithin the timeframe allowed in thecentralized procedure.Reference: EMA Press Release, EMA/583880/2010, 17 September 2010 at http://www.ema. europa.euMometasone furoate/formoterol fumarate:withdrawal of marketingauthorization applicationEuropean Union — The EuropeanMedicines Agency has been formallynotified by the manufacturer of its decisionto withdraw the application for acentralized marketing authorization formometasone furoate/formoterol fumarate(Zenhale®) 50/5, 100/5 or 200/5 mg,pressurised inhalation.This medicine was intended to be usedfor long-term, twice-daily maintenancetreatment of asthma, including reductionof asthma exacerbations, in adults andchildren aged 12 years or older.The decision to withdraw the applicationwas based on the manufacturer’s inabilityto address CHMP requests to provideadditional data within the timeframeallowed in the centralized procedure.Reference: EMA Press Release, EMA/700091/2010, 9 November 2010 at htp://www.ema. europa.euEMA and US FDA extendconfidentiality arrangementsindefinitelyEuropean Union/United States ofAmerica — The European MedicinesAgency (EMA) and the United StatesFood and Drug Administration (FDA)have extended their confidentiality arrangementsrelated to medicinal productsfor human and veterinary use, followingthe positive experience gained since theinitial arrangements were signed inSeptember 2003. This cooperation willnow continue indefinitely without the needfor further renewal.The confidentiality arrangements allowboth Agencies to exchange confidentialinformation as part of their regulatory andscientific processes. Their aim is topromote public and animal health and toprotect European and US patients. Thetypes of information covered by thearrangements relate to scientific advice,orphan drug designation, paediatricdevelopment, good manufacturing practice(GMP) and good clinical practice(GCP) inspection planning and reports,marketing authorization procedures andsubsequent changes to the marketingauthorizations together with post-marketingsurveillance.Reference: EMA Press Release, EMA/579151/2010, 15 September 2010 at http://www.ema. europa.eu309
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WHO Drug Information Vol. 24, No. 4, 2010

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