Herceptin®

HERCEPTIN® as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

Fifteen patients experienced pulmonary and other adverse events following HERCEPTIN® use, which culminated in a fatal outcome. Nine of these patients had onset of symptoms within 24 hours of infusion and subsequently died. It is estimated that 25,000 patients have been treated with HERCEPTIN® worldwide since marketing approval.

Serious adverse events of greater severity than previously reported include: urticaria, bronchospasm, angioedema, hypotension, dyspnea, wheezing, pleural effusions, pulmonary infiltrates, noncardiogenic pulmonary edema, and pulmonary insufficiency and hypoxia requiring supplemental oxygen or ventilatory support.

In the majority of patients the symptoms occurred with the first dose of HERCEPTIN®. While the time of onset of symptoms most often occurred during the infusion or within the first 12 hours following the infusion, events were also reported to have occurred 24 hours or more after the infusion. In some cases, patients improved after the initial reaction, but experienced marked clinical deterioration at a later time point. In a small number of cases the patients died at home.

Most patients with fatal events had significant pre-existing pulmonary compromise secondary to intrinsic lung disease and/or malignant pulmonary involvement. Because it appears that patients with significant pre-existing pulmonary compromise may be at greater risk, these patients should be treated with extreme caution. Patients experiencing any of the severe infusion-associated symptoms mentioned above, or in the prescribing information, should have the HERCEPTIN® infusion discontinued and appropriate medical therapy administered. Patients should be closely monitored until complete resolution of their symptoms. In addition, patients should be informed of the possibility of delayed severe reactions.

Source: fda.gov

If you or a loved one has been harmed by Herceptin®, you may want to contact a Herceptin® attorney for more information.