Epogen in the News--New FDA Warning

Sappho · Post by **Sappho** » Mon Mar 12, 2007 2:48 am

http://www.comcast.net/news/health/inde ... 07589.html

FDA Issues New Warnings on Anemia Drugs
By Associated Press

Sun Mar 11, 4:04 AM

WASHINGTON - Federal health officials issued stern new warnings Friday for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.

At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells.

Anemia is common with certain forms of kidney disease, especially once a patient is on dialysis, and when cancer patients take chemotherapy.

But the Food and Drug Administration pointed to recent studies that found using too much of the drugs increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses.

Even when the anemia drugs were used at FDA-recommended doses, giving them to cancer patients not on chemotherapy increased the risk of death, the agency warned. Moreover, some doctors have begun giving the drugs to patients following orthopedic surgery, also increasing the risk of blood clots, FDA said.

Friday, the agency added stern warnings to each of the drug's labels urging that:

_doctors monitor patients' levels of red blood cells and use the lowest possible dose to avoid the need for blood transfusions.

_doctors and patients carefully weigh the risks of using anemia drugs vs. the risk of a transfusion if anemia gets too bad.

Amgen Inc. and Johnson & Johnson, companies that manufacture and market the drugs, both said they would work to inform doctors about the new warnings, outlined in a so-called "black box." The warnings are the most serious a drug label can bear.

"Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice," said Dr. Roger Perlmutter, Amgen' s executive vice president of research and development.

The FDA also said it would take a new look at how the drugs are marketed, including claims they can improve the quality of life of cancer patients. The Web site for Procrit, for example, says the drug "helps you find the strength you need."

"With the new label being revised today, we will certainly evaluate any marketing claims and revise them as needed," said Stephanie Fagan, a spokeswoman for J&J's Ortho Biotech Products LP.

A panel of FDA advisers is scheduled to discuss the drugs at a May 10 meeting. Their recommendations could lead to further revisions of the drugs' labels, FDA officials said.

In December, lawmakers and some experts raised concerns that Medicare's payment system encouraged overuse of Epogen, endangering patient lives and wasting taxpayer money. FDA officials said they would forward the recent data on the class of drugs to the Centers for Medicare and Medicaid Services.

The three drugs are huge sellers, with combined 2006 U.S. sales of $10 billion, according to IMS Health Inc.

colbertnationgirl · Post by **colbertnationgirl** » Mon Mar 12, 2007 1:04 pm

Welcome to the forum Sappho!!

This is very interesting!! I wonder how much of the $10 billion of sales came from the Order.

Mirage · Post by **Mirage** » Mon Mar 12, 2007 8:42 pm

Good Lord, I just realized that the place my boyfriend works at, Amgen, manufactures Epogen.

Sappho · Post by **Sappho** » Tue Mar 13, 2007 12:57 am

Thanks for the warm welcome. I think it would be evil to give this drug to a perfectly healthy young girl, since it can have serious side effects. So the Order is definitely not good guys, if there was ever doubt.

I don't think Amgen will be laying people off or anything, Mirage. They won't be able to market as aggressively, and their stock may drop in the short run. Epogen is still recommended for people with anemia due to chemo. Just, not everyone with anemia. Not girls getting ready for ceremonies lol.

Marbella · Post by **Marbella** » Tue Mar 13, 2007 8:52 am

Thank you so much, Sappho and WELCOME!!

Hey, I had heard about that but hadn't read the full article. Very nice for you to "debut" here with such a great contribution!

I also know someone (a corporate lawyer for a pharmaceutical company) which worked for a company that was in competition with Epogen. So, I was excited and talked to him about it.

Mirage · Post by **Mirage** » Tue Mar 13, 2007 8:57 am

Sappho wrote:

I don't think Amgen will be laying people off or anything, Mirage. They won't be able to market as aggressively, and their stock may drop in the short run. Epogen is still recommended for people with anemia due to chemo. Just, not everyone with anemia. Not girls getting ready for ceremonies lol.

*wipes off forehead sweat* Good, good. Not that the fact that the stock might drop is anything to cheer about, but could you imagine me telling the boyfriend that I have a feeling he might get layed off---because of Lonelygirl?

Maybe I'll ask him if he's seen any mysterious all-in-black-with-sunglasses strangers lately.

Welcome to the forums, Sappho, I hope you have a great time posting (and playing) here.

Marbella wrote:Thank you so much, Sappho and WELCOME!!

Hey, I had heard about that but hadn't read the full article. Very nice for you to "debut" here with such a great contribution!

I also know someone (a corporate lawyer for a pharmaceutical company) which worked for a company that was in competition with Epogen. So, I was excited and talked to him about it.

Uh oh, competition!

Libra · Post by **Libra** » Tue Mar 13, 2007 9:08 am

colbertnationgirl wrote: I wonder how much of the $10 billion of sales came from the Order.

Hahah CNG that was my reaction to the article too!

Welcome Sappho! Nice contribution