The FDA has issued the 'black box' warning- the highest level of warning, to the genetically engineered drugs, erythtropoietins, that are meant to counteract anemia.
These drugs, such as Epo, are given to patients suffering from anemia caused by chemotherapy and kidney failure. They are hormone-based drugs, usually derived from kidneys.
It was seen that there was a more than a warranted number of complications such as blood clots, strokes heart attacks and even early death arising from over use of the drug. This was seen especially in patients with chronic kidney failure.
These drugs are among the top 3 selling drugs in the U.S and major producers Amgen and Johnson and Johnson reported record sales of 10 billion dollars last year.
The drugs are advertised directly to consumers, even though they are extremely expensive and given only by injection.
Recent studies suggest that the drugs, which are commonly prescribed to cancer patients receiving chemotherapy, may actually make tumors grow faster and increase the risk of death, if given in high doses. This is according to the FDA's official Richard Pazdur, who announced the new "black box' warning.
The 'black box' warning cautions that the drugs should be used at the lowest dose necessary to avoid the need for a blood transfusion. They should not be used to fully reverse anemia.
The FDA's public health advisory yesterday could now mean that physicians are likely to be more light-handed in their use of these drugs.