Warning labels on anemia drugs made by Amgen and Johnson & Johnson have been strengthened to reflect concerns the drugs boost risk of heart attacks, stroke and death, regulators said Thursday.
Millions of cancer and kidney disease patients take the drugs, known as erythropoiesis-stimulating agents or EPO drugs, which include Amgen's biggest drug Aranesp and an older version, Epogen, and J&J's Procrit.
The class of drugs has been under a cloud since a study showed increased risk of death in cancer patients whose anemia was not caused by chemotherapy. There have also been concerns that the medicines were being overused in kidney dialysis patients.
The U.S. Food and Drug Administration said the labeling changes reflect new data on potential adverse effects, including six studies that suggest the drugs result in decreased survival or tumor growth.
"The FDA strongly recommends that prescribers talk to their patients about the risk that ESAs might cause cancer to grow more quickly or shorten survival before they prescribe these drugs," Dr. Richard Pazdur, FDA's cancer division chief told reporters on a conference call.
The FDA also mandated that all patients be given a new medication guide outlining the drugs' risks.
Aranesp is approved to treat anemia associated with chemotherapy and kidney disease. Epogen is used to treat anemia associated with kidney disease. The two drugs generated 2006 sales of $4.1 billion in 2006.
But worldwide Aranesp sales fell 23 percent to $818 million in the third quarter as doctors stopped using it in cancer patients who were not undergoing chemotherapy, and other regulatory and reimbursement changes began to take a toll.
Epogen sales fell 5 percent to $602 million, while sales of J&J's Procrit plunged 27 percent to $380 million.
The updated label for Aranesp includes instructions that therapy be stopped after completion of a chemotherapy course, and that no more of the drug should be given than needed to avoid a blood transfusion.
The warnings state that a patient's level of oxygen-carrying hemoglobin should not rise above 12 grams per deciliter of blood for patients with cancer.
They also add that the risks of shortened survival and cancer progression "have not been excluded" when the drugs are given to achieve hemoglobin of less than 12 grams per deciliter.
Debate Continues Over Hemoglobin Targets
The new label for use in cancer patients is more benign than some feared, following a decision by the Medicare health insurance program to pay for the drugs only when a patient's hemoglobin falls below 10 grams per deciliter of blood, according to one industry watcher.
"It is far less strident than some of the noise that surrounded the (FDA expert panel) meetings," said Ira Loss, an analyst at Washington Analysis.
The FDA convened two advisory panels this year to discuss concerns about safety of the anemia drugs and to recommend changes. FDA officials stressed that 12 grams per deciliter should not be considered a target, but an upper boundary for safety.
Amgen, the world's largest biotechnology company by sales, is fighting the restrictive ruling on Medicare reimbursement, which accounts for a larger chunk of patients taking the medicines.
FDA officials said on Thursday the new labeling is consistent with the Medicare decision.
The company said it plans to submit new evidence to the Medicare agency to convince it to reverse its decision. Six new clinical trials have been designed to assess the safety of the EPO drugs when used to treat chemotherapy-induced anemia in specific tumor types, Amgen said.
In chronic kidney failure patients, the new label advises dosing within a range of 10 grams and 12 grams per deciliter.
Amgen shares edged up 25 cents to $56.43 on Nasdaq, while J&J rose 64 cents to $64.56 on the New York Stock Exchange.