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The deaths of two patients of liver damage while taking the cancer drug tarceva have prompted new warnings from OSI Pharmaceuticals and Genentech.
Doctors have received letters saying that patients with a history of liver problems must be closely monitored while taking the drug. The Food and Drug Administration in the US has posted the letter on its website.
Tarceva – which is approved to treat lung cancer and pancreatic cancer – is made by OSI and sold by Genentech. The companies said the two patients died of liver complications within 30 days of taking the last dose.
The 15 patients enrolled in the study were thought to have moderate liver problems, but the companies said that follow-up analysis suggests their conditions were more severe.
The companies have added stronger warnings about liver toxicity to the drug’s label.
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