FDA: More risks from anemia drugs

The FDA dealt another blow to embattled anemia drugs yesterday. The agency revealed two new studies that show cancer patients may be more likely to die while using Amgen's blockbuster drugs Aranesp and Epogen (also sold under the brand name Procrit by Johnson & Johnson).

The drugs, known as erythropoiesis stimulating agents (ESAs), are already under safety review by regulators. In November, new warnings of their cancer risks--that tumors might grow faster and patients may die sooner, according to four other studies--were added to their labels. Other research has shown that ESAs pose increased risk of heart attack, stroke, and heart failure. The risks are greatest with high doses of the drugs, so several months ago, Medicare limited reimbursement to lower doses. Some insurers followed suit.

Now, according to an FDA statement, the agency "may take additional action." If regulators further restrict the drugs, Amgen would be deeply wounded. ESAs account for more than half the company's profits.

- see the FDA release
- get details about the newly released data
- read the article from the Los Angeles Times

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.