Amgen, J&J strengthen anti-anemia drug label warnings

14 November, 2007

Pharmaceutical companies Amgen as well as Johnson & Johnson have strengthened the label warnings for their drugs that are widely used to treat anemia.

The new warnings further stress the risks the three medicines pose – such as heart attacks, a worsening of cancer, and death.

The changes came after the drug advisory committee of the United States Food and Drug Administration (FDA) held two meetings to consider the safety of the three drugs in question –Epogen and Aranesp made by Amgen, and Procrit made by Johnson & Johnson.

According to the FDA, accumulated data have suggested that the drugs Epogen, Aranesp, and Procrit can be dangerous if overused.

The new warnings also state, for the first time, that the risks of the three drugs for cancer patients “cannot be excluded even at doses previously considered safe and routinely used.”

The three drugs are used by about 1 million people – mostly those with anemia caused by cancer chemotherapy or kidney failure – in the United States a year.

The combined sales of Epogen, Aranesp, and Procrit worldwide are around $10 billion in 2006.

Amgen has said that the new labels on its drugs Epogen and Aranesp “support its cause” and that, for cancer patients, “the label calls for using the lowest possible dose that allows a patient to avoid blood transfusions, with hemoglobin levels not to exceed 12 grams for each decilitre.”

Amgen also said it would present some new evidence, including information showing that more cancer patients now need blood transfusions.

The FDA had initially imposed a “black box” warning – the most serious one a drug can carry – on the three drugs in March 2007 as an interim measure.

For patients with kidney failure, the new label calls for hemoglobin levels to be maintained at between 10 and 12.

The new wording in the label asks doctors to exercise restraint or even discontinue use of the drugs for patients who do not reach the desired hemoglobin levels after 12 weeks of treatment.

Till now, dialysis centers have reportedly been giving very high doses to patients in order to increase their hemoglobin levels.