Amgen expanded the Black Box warnings about the risks of death and tumor growth with its blockbuster anemia drugs, Aranesp and Epogen. The warnings come less than a week before an FDA advisory committee meets to discuss the risks associated with these meds, a group known as ESAa and which also includes Johnson & Johnson’s Procrit. J&J does the same.

Specifically, the warning says the drugs, which are used to treat anemia in patients with kidney failure and on chemotherapy, increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer. The label notes the problems occurred when docs treated patients with elevated levels of the drugs, according to Amgen’s statement.

Since FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent and US sales of its anemia meds fell more than 10 percent to $6.3 billion for the year, the Associated Press notes.

Wall Street analysts expect sales to fall further in 2008 following next week’s FDA meeting. The panel could recommend halting use of the drugs for certain types of cancers, or in all cancer patients. Recommendations will not apply to Amgen’s Epogen, which is used almost exclusively by kidney failure patients on dialysis. If FDA removes only some cancer indications, Amgen’s anemia drug sales could lose between $150 million to $250 million for 2008, according to estimates by Goldman Sachs analyst May-Kin Ho.

FDA twice updated anemia drug labels last year, most recently in November. Amgen disclosed new data in December on the risks in early stage breast cancer and cervical cancer patients, sending shares downward nearly 20 percent. The new label incorporates detail from those studies.

Bear Stearns analyst Mark Schoenebaum says the effect of Friday’s changes would be minimal for Amgen, since cervical cancer accounts for about 1 percent of the Aranesp market. He also noted that the previous label already highlighted the breast cancer risks.

But Stanford Group analyst Gregory Frykman says the new warnings could attract tougher regulations from Medicare, the government’s health plan for seniors. Last summer, Medicare ruled it would only pay doc to administer anemia drugs if they were prescribed at low levels. He adds that the new warnings could convince Medicare to scale back its policy again, perhaps only paying for the drugs when used in certain types of cancer.

Source: The Associated Press