WASHINGTON - Recent studies highlight the potentially fatal dangers of anemia drugs sold by Johnson & Johnson and Amgen when they're given to certain cancer patients, regulators said yesterday.
The Food and Drug Administration said it may take additional action to ensure that two Amgen products, Epogen and Aranesp, and Johnson & Johnson's Procrit are used safely.
The drugs are used to treat anemia, a blood disorder, when it's caused by kidney failure or chemotherapy.
The FDA reviewed data first disclosed by the companies in early December.
Two studies showed women with advanced breast and cervical cancer died sooner or had faster tumor growth when taking the drugs at higher-than-recommended levels, the FDA said. Although the drugs are not FDA-approved at those higher doses, doctors have prescribed them anyway, believing they improve patients' quality of life.
The breast cancer study conducted by Amgen showed 14 percent of patients on Aranesp died after three years versus 9.8 percent of patients not taking the drug.
A separate study of women with cervical cancer showed 66 percent of patients not taking Johnson & Johnson's Procrit were alive and free of cancer growth, compared with 58 percent of those taking the drug.
The FDA said it was not aware of the results in November, when it added warning labels emphasizing the drugs' risks in patients with other types of cancer. Agency officials said they may take more action given the data, which underscore the drugs' risks for patients with breast and cervical cancer.
Analysts expect the agency's panel of cancer experts to consider the latest studies at a meeting in March, though the agency has not confirmed that.
