FDA approves new warnings on anemia drugs

Nov 09, 2007

The U.S. Food and Drug Administration has approved revised warnings and labeling changes for the anemia drugs Aranesp, Epogen and Procrit.

The warnings on the erythropoiesis-stimulating agents address the risks that the drugs pose to patients with cancer or chronic kidney failure, the FDA said Friday in a release.

The FDA said the labeling changes include a statement that symptoms of anemia, fatigue and quality of life haven't been shown to improve in patients with cancer who are treated with ESAs.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery and for the treatment of anemia caused by zidovudine therapy in HIV patients.

The new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter or greater, the release said.

Copyright 2007 by United Press International

Explore further: High-dose opioid prescribing continues to climb

add to favorites email to friend print save as pdf

Related Stories

New jigsaw piece for the repair of DNA crosslinks

May 27, 2014

Environmental influences such as ionizing radiation, intense heat or various chemical substances damage the DNA constantly. Only thanks to efficient repair systems can mutations – changes in the DNA – ...

Recommended for you

High-dose opioid prescribing continues to climb

Sep 12, 2014

High-dose opioid prescribing increased by 23 per cent in Canada between 2006 and 2011, despite clinical guidelines recommending that most patients should avoid high-doses of these drugs, according to new ...

Feds say Bayer colon supplement makes bogus claims

Sep 12, 2014

The United States government accused Bayer of making scientifically unproven statements about the health benefits of a popular probiotic on Friday, claiming the German pharmaceutical giant was in contempt of court.

FDA approves weight-loss drug Contrave (Update)

Sep 11, 2014

U.S. regulators have greenlighted a new weight-loss drug called Contrave, the third in a string of approvals for prescription medications aimed at the nation's 78 million obese adults.

User comments : 0