Novartis informs about telbivudine-related peripheral neuropathy

Reactions 1194 - 22 Mar 2008 Novartis informs about telbivudine- related peripheral neuropathy Novartis has issued a ‘Dear Health Care Professional’ letter 1 and a ‘Public Communication’, 2 both endorsed by Health Canada, to inform about an increased risk of peripheral neuropathy in patients with chronic hepatitis B infection who receive telbivudine and peginterferon-α-2a. According to the company, peripheral neuropathy developed in eight patients out of a total of 48 patients who had received both telbivudine [Sebivo] 600 mg/day and peginterferon-α-2a [Pegasys] 180 µg/week in a clinical trial. 1 Five of the eight patients developed serious peripheral neuropathy with an onset time of about 1–6 months, and the study drugs were discontinued in these patients. Also, peripheral neuropathy was reported as an uncommon event in another trial of telbivudine monotherapy, with an incidence of 0.3% (5/2000); neuropathy was categorised as serious in two of these patients. The company says that benefits of telbivudine plus interferon treatment have not been established in patients with chronic hepatitis B infection and that it is in the process of updating Product Monograph and Consumer Information for telbivudine to reflect this new safety information. 1 Sebivo is not authorised by Health Canada for use in combination with any interferons. 2 Novartis has advised patients to inform their doctor if they are receiving Sebivo and an interferon product in combination as it may increase their risk of developing peripheral neuropathy. However, patients are advised not to discontinue or alter their treatment without consulting their doctors as it may worsen the underlying hepatitis B infection. 1. Novartis Pharmaceuticals Canada Inc. Risk of peripheral neuropathy in patients treated with telbivudine (SEBIVO Rm) and interferon. Internet Document : [2 pages], 7 Mar 2008. Available from: URL: http://www.hc-sc.gc.ca. 2. Novartis Pharmaceuticals Canada Inc. Health Canada Endorsed Important Safety Information on SEBIVO (telbivudine). Media Release : 12 Mar 2008. Available from: URL: http://www.hc-sc.gc.ca. 801099513 » Editorial comment: Following these study findings, the EMEA has recommended adding new warnings about the risk of peripheral neuropathy in the product information for telbivudine (see Reactions 1190 p5; 809085293). 1 Reactions 22 Mar 2008 No. 1194 0114-9954/10/1194-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Transcript of Novartis informs about telbivudine-related peripheral neuropathy

Reactions 1194 - 22 Mar 2008

Novartis informs about telbivudine-related peripheral neuropathy

Novartis has issued a ‘Dear Health Care Professional’letter1 and a ‘Public Communication’,2 both endorsed byHealth Canada, to inform about an increased risk ofperipheral neuropathy in patients with chronichepatitis B infection who receive telbivudine andpeginterferon-α-2a.

According to the company, peripheral neuropathydeveloped in eight patients out of a total of 48 patientswho had received both telbivudine [Sebivo] 600 mg/dayand peginterferon-α-2a [Pegasys] 180 µg/week in aclinical trial.1 Five of the eight patients developed seriousperipheral neuropathy with an onset time of about1–6 months, and the study drugs were discontinued inthese patients. Also, peripheral neuropathy wasreported as an uncommon event in another trial oftelbivudine monotherapy, with an incidence of 0.3%(5/2000); neuropathy was categorised as serious in twoof these patients.

The company says that benefits of telbivudine plusinterferon treatment have not been established inpatients with chronic hepatitis B infection and that it is inthe process of updating Product Monograph andConsumer Information for telbivudine to reflect this newsafety information.1 Sebivo is not authorised by HealthCanada for use in combination with any interferons.2Novartis has advised patients to inform their doctor ifthey are receiving Sebivo and an interferon product incombination as it may increase their risk of developingperipheral neuropathy. However, patients are advisednot to discontinue or alter their treatment withoutconsulting their doctors as it may worsen the underlyinghepatitis B infection.1. Novartis Pharmaceuticals Canada Inc. Risk of peripheral neuropathy in patients

treated with telbivudine (SEBIVO Rm) and interferon. Internet Document : [2pages], 7 Mar 2008. Available from: URL: http://www.hc-sc.gc.ca.

2. Novartis Pharmaceuticals Canada Inc. Health Canada Endorsed Important SafetyInformation on SEBIVO (telbivudine). Media Release : 12 Mar 2008. Availablefrom: URL: http://www.hc-sc.gc.ca.

801099513

» Editorial comment: Following these study findings, theEMEA has recommended adding new warnings about the risk ofperipheral neuropathy in the product information for telbivudine(see Reactions 1190 p5; 809085293).