Stronger Warnings on Anemia drugs

After FDA’s concerns about the drugs made by Amgen and Johnson and Johnson for anemia patients, the drug makers have updated the warnings on the labels.

Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit have been large selling medicines for Anemia, but the sales have suffered a bit after the Food and Drug Administration asked the companies to put stronger warning signals. These warnings emphasize on the fact that these medicines increase risks to diseases like death and stroke.

A new boxed warning label warning will state that if these drugs are overused then they can increase the risk to these diseases. It also states that the risk is substantial for cancer patients even at the doses which were considered safe earlier, but confirmations to this will come only after six more studies which will be conducted by the companies.

For cancer patients, the dosage is recommended to a level that avoids blood transfusions, with hemoglobin levels not to exceed 12 grams per deciliter.

“The label gives physicians discretion between 10 and 12,” Kevin W. Sharer, Amgen’s chief executive, told securities analysts yesterday. “That’s the main point. And the C.M.S. decision does not.”

These drugs are used to treat the blood-disorder anemia in kidney-failure and chemotherapy patients and belong to a class known as erythropoiesis-stimulating agents or ESA’s. ESA’s help in the formation of red blood cells as these biologically engineered proteins similar to the ones in kidney which cause bone marrow to produce RBC’s.

"ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions," said Dr Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs.

Sales of medicines have already been on a decline because of a policy by the name of Medicare. It states that the doctors will only be paid if they recommend low use of drugs to their patients. Doctors have been asking for the overturning of this rule as they think that sometimes higher doses are necessary.

Eric Schmidt, who is a Wall Street analyst, thinks that this move is not altogether negative as it does not restrict the dosage and the doctor can proceed the way he feels is good for the patient.

"Although the label encourages a minimum dose in cancer patients, it does not restrict dosing," Schmidt wrote in a research note.

Amgen also plans to use this fact to renew a request for the reversal of this rule. They pointed out that even the new labeling leaves the decision of the dosage to the doctor, so the rule is invalid and inappropriate.