Limits on anemia drug are advised
A Food and Drug Administration advisory panel recommended Thursday that the agency place new restrictions on prescriptions for a popular Amgen Inc. and Johnson & Johnson anemia drug because of safety concerns.
Although the panel called for more studies to determine exactly what those restrictions should be, medical experts and industry analysts predicted the decision would reduce demand for the drug, sold by Amgen under the brand names Epogen and Aranesp.
The medication accounts for nearly half of the revenue at Thousand Oaks-based Amgen, whose shares plunged 9%.
Another version of the medicine is licensed to Johnson & Johnson and sold under the name Procrit.
“Everyone is more concerned, definitely,” said Alfred Chin, a pharmacist at USC Norris Cancer Center and an associate professor of pharmacy at the university. “Doctors will be a lot more careful about prescribing it.”
Some industry analysts predicted that sales for the drug, prescribed to more than 1 million people in the U.S. each year, could drop by as much as 20%.
Erythropoietin, the main ingredient in all three brands, helps treat anemia in cancer and dialysis patients. But in recent months, scientific studies, including one by Amgen, have raised doubts about the drug’s benefits for some types of cancer patients and raised concerns that it might cause certain tumors to grow. In high dosages, the drug also may increase the risk of heart attack and stroke, researchers have found.
In March, the FDA required that the three versions of the drug carry labels warning about possible risks and recommended that doctors prescribe the minimum possible amounts. The agency also announced that a panel of cancer specialists would look into the issue.
On Thursday, the FDA’s Oncologic Drugs Advisory Committee met in Silver Spring, Md., to discuss the issue and make recommendations.
Roger Perlmutter, Amgen’s head of research and development, told the panel that the drug was safe when used properly.
“We want to consider the totality of the evidence, and consider what’s best for patients,” Perlmutter said, according to Bloomberg News. The drug did not shorten patients’ lives or make tumors spread more rapidly in dozens of other studies, he said. The company did not respond to a request for an interview from The Times.
Some in the 17-member panel, which included cancer experts from across the country, suggested that the company was not being upfront about all the drug’s risks, a charge that Amgen executives denied.
In the end, the committee called for more detailed warnings and restrictions on the use of the drug, and further studies by Amgen and Johnson & Johnson to determine what those warnings and restrictions should be.
Karen Riley, a spokeswoman for the FDA, said the agency had no time frame for completing the process.
Nonetheless, doctors are likely to heed a vote of little confidence from a panel of national cancer experts and write fewer prescriptions or recommend smaller doses, USC’s Chin said. Some health insurers have already dropped coverage of the drug for certain uses.
Epogen is prescribed to cancer patients while Aranesp and Procrit are prescribed to kidney failure patients on dialysis. Amgen and New Brunswick, N.J.-based Johnson & Johnson sold about $10 billion worth of the drug last year, with Epogen and Aranesp accounting for 47% of Amgen’s revenue.
Len Lichtenfeld, deputy chief medical officer for the American Cancer Society in Atlanta, said the drug had helped millions of patients deal with the rigors of cancer treatment, which can lead to anemia, a kind of fatigue caused by lack of hemoglobin, a protein in red blood cells that carries oxygen from the lungs to the rest of the body.
Epogen is approved for such use, but doctors also have prescribed the drug for “off-label” use in cancer patients whose anemia is not a side effect of treatment, Lichtenfeld said. Some physicians also have upped the recommended dosage in other cases, hoping for better results.
Off-label uses are common in medicine, but in this case the consequences might not be fully known, he said.
“We need more studies,” Lichtenfeld said, “but we must not lose sight of the fact that this drug is of important value for many cancer patients.”
Amgen shares fell $5.77 to $57.33, before bouncing back slightly to $57.87 in after-hours trading. Johnson & Johnson shares fell $1.61, or 2.5%, to $62.50, before rebounding to $62.75 after hours.