Overview on Shire and the Discontinuation of Ethmozine®: After the Heart Rhythm Society Intervenes, the Company Changes its D

The week of August 11, 2007, the Heart Rhythm Society became aware of a decision by Shire Pharmaceuticals to discontinue the production of Ethmozine ^® (morizine hydrochloride). The stated deadline was August 28, 2007. Sometimes manufacturers decide to withdraw medications from the market because of low volume sales. Under most circumstances, the discontinuation or halt in distribution of a specific pharmaceutical is manageable as there are alternative medications readily available that enable continued treatment with the same results. In some cases, the decision is problematic because patient safety may be compromised if they cannot gain access to the medication. This is especially true when sales of antiarrhythmic drugs are discontinued, because patients could experience adverse consequences from recurrence of their arrhythmias. The abrupt notice by Shire alarmed our members because there was very little time to adapt patient management strategies. Although Ethmozine ^® had not gained widespread usage, it has unique properties that may suppress heart rhythm disorders when other antiarrhythmic agents have failed, are poorly tolerated, or are contraindicated. I believe that Ethmozine ^® was used primarily under these circumstances, as opposed to first-line therapy, for treatment of patients with atrial or ventricular arrhythmias. Although there is no definitive data regarding the indications for its use, one reason was to suppress sustained ventricular arrhythmias in patients with implantable cardioverter defibrillators (ICDs). In such cases, these patients would be at increased risk for ICD shocks if their treatment was withdrawn. Shire s decision to discontinue the drug was based on business interests. The number of patients who were taking Ethmozine ^® when Shire made its decision was relatively small, so their decision to discontinue marketing Ethmozine ^® can be understood. However, the relatively short interval between this decision and the proposed date to end sales was problematic, because it did not allow physicians enough time to identify which patients were taking Ethmozine ^® and arrange for alternative management. In a letter dated August 16, 2007, I advised the manufacturer to reconsider its decision in the interest of patient safety. I recognized why Shire had decided to remove the drug from the market, but requested additional time for physicians to contact their patients and arrange for suitable treatment. I advised Shire that patients who were receiving Ethmozine ^® might need to be hospitalized to evaluate the best alternatives. In some cases, an ablation procedure might be required, or a trial of another drug could be indicated. I also emphasized that effective alternatives to Ethmozine ^® might be difficult to identify. The decision to withdraw Ethmozine ^® without an appropriate transition period could put some patients at risk of an adverse outcome. A conference call was convened with executives from Shire in order to discuss the implications of their decision and the need to modify the initial plan. Shire understood our concerns and was very receptive to recommendations from the Heart Rhythm Society. They agreed to keep Ethmozine ^® in stock until December 31, 2007, so that physicians would have sufficient time to identify alternative treatment for patients who might be prone to recurrent arrhythmias. Shire s revised plan reflects the positive influence HRS can exert on behalf of its members and their patients. I am indebted to the Heart Rhythm Society s staff, who monitored these problems and facilitated the steps needed for corrective action. For more information, please visit: www.HRSonline.org