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: Determine patient preferences by means of conjoint analysis

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

Determine patient preferences by means of conjoint analysis

9 hours ago

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

User comments : 0