Reactions 802 - 20 May 2000 Serious adverse events reported with trastuzumab Genentech has sent out a ‘Dear Healthcare Provider’ letter in the US regarding serious adverse events associated with trastuzumab [‘Herceptin’]. Product labelling will be revised accordingly with information on these adverse events, including a boxed warning. The company says that there have been 62 postmarketing reports of serious adverse events related to trastuzumab, including 15 deaths. These adverse events are characterised by ≥ 1 of the following categories: hypersensitivity, including fatal anaphylaxis; infusion reactions, including some with a fatal outcome; and pulmonary events, including adult respiratory distress syndrome and death. In most cases, the adverse event developed during the trastuzumab infusion or within the first 12 hours after the infusion. However, some of the adverse events occurred ≥ 24 hours after the infusion. Also, in some cases, the patient improved after the initial reaction, but subsequently experienced a marked clinical deterioration. Genentech says that patients with pre-existing pulmonary compromise may be at a greater risk of developing fatal adverse events associated with trastuzumab; the company warns that such patients should be treated with this agent with extreme caution. Genentech Inc. Important drug warning. Media Release : [2 pages], 3 May 2000. Available from: URL: http://www.gene.com 800820458 1 Reactions 20 May 2000 No. 802 0114-9954/10/0802-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Serious adverse events reported with trastuzumab

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Reactions 802 - 20 May 2000

Serious adverse events reportedwith trastuzumab

Genentech has sent out a ‘Dear Healthcare Provider’letter in the US regarding serious adverse eventsassociated with trastuzumab [‘Herceptin’]. Productlabelling will be revised accordingly with information onthese adverse events, including a boxed warning.

The company says that there have been 62postmarketing reports of serious adverse events relatedto trastuzumab, including 15 deaths. These adverseevents are characterised by ≥ 1 of the followingcategories: hypersensitivity, including fatal anaphylaxis;infusion reactions, including some with a fatal outcome;and pulmonary events, including adult respiratorydistress syndrome and death.

In most cases, the adverse event developed during thetrastuzumab infusion or within the first 12 hours afterthe infusion. However, some of the adverse eventsoccurred ≥ 24 hours after the infusion. Also, in somecases, the patient improved after the initial reaction, butsubsequently experienced a marked clinicaldeterioration.

Genentech says that patients with pre-existingpulmonary compromise may be at a greater risk ofdeveloping fatal adverse events associated withtrastuzumab; the company warns that such patientsshould be treated with this agent with extreme caution.Genentech Inc. Important drug warning. Media Release : [2 pages], 3 May 2000.Available from: URL: http://www.gene.com 800820458