The warning applies to Aranesp, Epogen and Procrit—drugs that are designed to fight anemia and are often prescribed to cancer patients undergoing, or having undergone chemotherapy.
The drugs are also used in patients suffering from kidney failure.
The toughened black box warning, updated in concert with the US Food and Drug Administration (FDA), arrives just a week before the FDA convenes an expert panel to further scrutinize the drugs. It is not known what stance the FDA will take, but there are several possibilities. The FDA could recommend that certain cancer indications be removed. Or, the panel could recommend that the anemia drugs in question not be used in cancer patients altogether.
The concern stems primarily from higher doses of the drugs, which appear to elevate red blood cells.
Amgen, based in Thousand Oaks California, manufacturers Aranesp, Epogen and Procrit—although the latter is licensed to, and marketed by Johnson&Johnson. The new warning label refers to the fact that dosage levels higher than those recommended tend to be consistent with the concerns identified, together with increased death and tumor growth in patients suffering from early stage breast and cervical cancers.
Previous label updates, the latest coming in November, warned of similar risks for other types of cancer.
The performance of Amgen's anemia drug trio has stalled since last March, when the FDA first began scrutinizing them. The label update in November was quickly followed by the release of new data in December pointing to risks for patients with early stage breast cancer and cervical cancer.
Sales have been falling since March of last yaer, and could take a further hit if Medicare scales back anemia drugs yet again. Last summer Medicare altered its policy to only pay for drugs if they were prescribed at low levels. Industry analysts say that Medicare could impose further restrictions, reducing sales even more.
It is believed that any recommendations coming out of the FDA panel discussions next week should not affect Epogen, as it is used primarily with kidney dialysis patients.
Over the last year, it has been reported that sales of Amgen's trio of anemia drugs have fallen 10 per cent, while shares in the company are down 27 percent.