The labeling on Amgen and Johnson & Johnson's anemia meds is about to get even more restrictive. Using its new authority to force label changes, the FDA is ordering the drugmakers to say the drugs shouldn't be used in chemotherapy patients whose cancer might be cured. The new label will also say that the drugs shouldn't be given when hemogrlobin levels are 10 grams per deciliter or more.
The label changes follow an FDA advisory panel meeting in March, when experts recommended usage limits--and another not adopted, that any patients with breast or head-and-neck cancers avoid the drugs. According to the Wall Street Journal, Amgen and the FDA had been negotiating new label language, but failed to come to an agreement.
You'll recall that a debate has been raging for months about the safety of these meds, which Amgen markets as Epogen and Aranesp, and J&J sells under the Procrit name. Medicare set up some restrictive guidelines for their use, saying it wouldn't reimburse for the meds outside those parameters. Given that Medicare's hemoglobin threshold was 10 grams per deciliter, it's unlikely that the new warnings will help loosen its purse strings.
- see Amgen's release
- read the WSJ story
- check out the article in the New York Times