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The U.S Food and Drug Administration warned on Thursday that
certain anti-anemia drugs are dangerous in treating patients suffering of
different types of cancer.
These anti-anemia drugs were approved in the treatments of
certain patients with cancer who suffer from anemia caused by chemotherapy.
According to this release, these drugs commonly referred to
as ESAs put those people’s lives on risks leading to tumor growth and less
chances of survival.
The considered anti-anemia drugs are on the market under
brand names Procrit, Epogen and Aranesp.
Ten billion dollars were generated from selling them only in the last year.
Aranesp and Epogen are manufactured by Amgen Inc. of Thousand Oaks, California.
Procrit is the only one distributed by Ortho Biotech of Bridgewater, N.J., a
subsidiary of Johnson & Johnson.
The FDA‘s representatives said on Thursday that they approve
some changes on the labels of these drugs. So the patients suffering of breast,
head and neck lymphoid and lung cancer are warned now about the threats these
drugs represent for them.
The new labels also contain a statement according to which
symptoms of anemia and fatigue doesn’t seem to improve in patients with cancer
who follow the treatment with ESAs.
ESAs are also used for patients with chronic kidney failure.
The new warning of the agency said that ESAs should be used to maintain a
hemoglobin level between 10 and 12. Hemoglobin levels higher than 12 grams per
deciliter in patients with chronic kidney failure might cause their death due
to cardiovascular reactions such as stroke, heart attack or heart failure.
The major concerns about the ESAs were discussed in May 2007
during meetings of FDA’s Oncologic Drug Advisory Committee and in a September
joint meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee and
the Drug Safety and Risk Management Advisory Committee. The labels of ESAs were
revised in 1997, 2004 and 2005 too.
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