Firms' anemia drugs tied to deaths
SAN FRANCISCO - Amgen Inc.'s and Johnson & Johnson's anemia drugs are tied to increased risks of death and faster-spreading tumors at high doses, a finding that may require new restrictions on the medicines, US regulators said.
Amgen's Aranesp and Epogen and J&J's Procrit showed greater risks for patients with cancers of the breast, head and neck, lung, and cervix in eight clinical trials, said staff of the Food and Drug Administration in briefing documents posted yesterday on the agency's website. An FDA advisory panel will consider benefits and risks of the products tomorrow in Gaithersburg, Md.
Amgen, the world's largest biotechnology company, lost $29 billion in market value last year after Aranesp, its top seller, and Epogen were tied to higher risks of heart attack, stroke, and death at high doses. The FDA urged doctors a year ago to use the lowest doses possible, and the agency updated safety warnings on the drugs' prescribing information last week.
"There is now mounting evidence of documented effects on survival, tumor progression," and blood clots, FDA staff said in the report. The evidence "requires a re-assessment of the net benefits of this class of drugs."
At the most extreme, the panel may recommend an end to use of the drugs for patients whose anemia is caused by cancer chemotherapy, allowing continued marketing mostly for kidney disease patients.
The committee also may suggest halting use of the products for certain types of patients found to be at greater risk, the FDA staff said. The agency may seek voluntary restrictions on advertising of the products and on offering incentives to doctors, according to the staff.
"As harsh as the questions sound, in our view, they do not contain any surprises," said Michael King, an analyst with Rodman & Renshaw in New York, in a note to clients yesterday. "We maintain our perspective that there is only a 10 percent chance that Aranesp will be completely contraindicated," or prohibited, for use among cancer patients.
Amgen fell 6 cents to $44.62 in Nasdaq Stock Market Composite trading. Amgen, based in Thousand Oaks, Calif., has dropped 27 percent in the past 12 months. J&J rose $1.11 to $62.44 on the New York Stock Exchange.
There is "insufficient evidence" to rule out risks from the anemia drugs at recommended doses, because all of the trials showing danger were performed at higher-than-recommended doses, the FDA staff said.
One trial was designed in 2004 to examine safety at recommended doses, although patient enrollment in the study has been slow so it will take "many years" to see a result, according to the staff report.
