Anemia Drugs Might Get Stronger Warnings

Widely used anemia drugs marketed by pharmaceutical giants Amgen Inc. and Johnson & Johnson raise the risk of death among cancer patients by about 10 percent, an analysis of 20 years of clinical trials noted.

Further linking the drugs to potential harms, studies found an increased blood clot risk of 57 percent among patients receiving the anti-anemia drugs.

The analysis is published in this week's Journal of the American Medical Association.

Anemia, the most common disorder of the blood is defined as a qualitative or quantitative deficiency of hemoglobin inside the Red Blood Cells (RBC). The drugs developed to treat anemia boost the RBC count in blood, and are typically used to treat patients with kidney disease and cancer patients receiving chemotherapy.

The study – called a meta-analysis - combines data from 51 clinical trials involving 13,611 patients. The results show a statistically significant increase in the risk of blood clots and death from the drugs, quoted Dr. Charles L. Bennett, professor at Northwestern University and lead author of the study.

Meanwhile, the Food and Drug Administration has urged doctors to use the lowest doses possible. The Food and Drug Administration also plans to convene an advisory committee meet on March 13 to review the latest clinical trial results and whether to impose restrictions on the use of the drugs, Aranesp from Amgen and Procrit from Johnson & Johnson.

Commenting upon the results of the latest clinical trails, Ortho Biotech, the Johnson & Johnson unit that markets Procrit, said the new study does not "provide an accurate reflection of the safety profile" of the anti-anemia drugs.

The products are safe and effective when used according to product labeling, the company said.

Also, the risk of using the drug should be balanced against the treatments that the patients might need if their anemia goes untreated. "The risks were mostly seen among patients taking high doses", study coauthor Samuel Silver, a hematologist at the University of Michigan Medical Center in Ann Arbor concluded.