Stronger Anemia Drug Warning for Patients Recommended

[Posted by FDA on 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of = 12 g/dL.

Where You Live Effect Reponse To A Cancer Drug?

Now that's a scary idea.  But it just may be true for one of the new targeted therapies in use for colon and head and neck cancers. Researchers reporting in this week's New England Journal of Medicine have found that some patients in the U.S . south have pre-existing immunities that can cause a life-threatening allergic reaction to the drug Erbitux.   The researchers say the patients had antibodies against Erbitux that may have been generated in response to aregionally prevalent pests like ticks, roundworms, or microbes. The problem is bad enough that the researchers suggest testing for the antibodies before prescribing  Erbitux for patients from certain parts of the country.

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While the percentage of Americans 50 and older getting screened increased from 54% t0 61% between 2002 and 2006, use of the screening tests among racial and ethnic minorities lagged as well as among people without insurance, with lower incomes  and without a high school education.