Anemia drug warnings

[Mary]

Please see the news story below. It can be quite discouraging for patients to read warnings about the drugs that we are taking. While these warnings are serious, the warnings about chemotherapy are also very serious. In many cases, drugs are combined in the hopes of increasing patients' chances of making a full recovery with less long-term damage. This means that more potential side effects "stack up" even as the potential benefits stack up. Please talk to your doctor if you are concerned about these risks. I believe that transfusions are an alternative to some of these drugs for chemo patients? There may be other alternatives as well.

Associated Press
WASHINGTON - Amgen and Johnson and Johnson have strengthened warnings about the risks, including death and stroke, associated with their blockbuster anemia drugs.

While sales of the drugs have suffered since the Food and Drug Administration raised safety concerns earlier this year, analysts said Thursday's action could provide some relief since the labeling is not as restrictive as it could have been.

The new labeling applies to Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit, which are used to treat the blood-disorder anemia in kidney-failure and chemotherapy patients. A new boxed warning label, the most serious a drug can carry, emphasizes that cancer patients had increased risk of death and showed accelerated tumor growth when treated with elevated doses of the drug. In March, the FDA approved a less serious warning that described studies that showed the risks.

The FDA said it is still unclear whether cancer patients face the same risks even when using normal doses of the drugs. The companies said they hope to answer that question by conducting six additional studies in different types of cancer patients.

At the FDA's request, the companies also strengthened a warning that using the drugs in higher doses can increase risk of heart attack, stroke and death in kidney failure patients. The label cautions physicians that using higher-than-recommended doses of the drugs does not benefit patients. Many doctors have prescribed elevated doses with the assumption it improves patients' quality of life.

Wall Street analysts, including Cowen and Co.'s Eric Schmidt, viewed the news in a positive light, noting that the labeling stops short of telling doctors exactly how much of the drugs to use.

"Although the label encourages a minimum dose ... in cancer patients, it does not restrict dosing," Schmidt wrote in a research note.

The FDA's stance on dosing could help bolster Amgen and Johnson & Johnson's arguments that a policy set in place by Medicare officials earlier this year is overly restrictive.

[Mary]

The FDA warning is clear about the patients who are at higher risk based on the studies that have been done so far. It's not just "any cancer patient." If you are worried, read more here:

http://www.procrit.com/procrit/assets/PHA.pdf#zoom=100

Procrit's site gives some more general recommendations based on the FDA warning:
http://www.procrit.com/procrit/patient.html

[Tara]

I took Procrit a few times.  The first 2 or 3 I felt fine.  The last 3 I had horrific headaches.  I have migraines, so I have something to compare them too.  The last one beat a migraine hands down.  I was grateful I was at the hospital then, because they gave me really good drugs and were able to monitor me.  The first they started off with was two 10mg Lorcet tablets, which didn't make a dent in the pain. Took several "cocktails" and about 24 hours before the pain stopped.  Due to that and the fact that Procrit made national headlines that week with the higher incidents of stroke rates, my onc took me off of it.  We took a wait and see kind of approach since I stayed at home and had in-home childcare as well.  The only time we did anything was when I was going on vacation - then they gave me a transfusion which was WONDERFUL!!  I felt great within 24 hours. 
If you feel funny taking them, don't.  Your body will tell you that something is not going right.  Just listen to it!  Make sure your doctor does too.

[Desiree]

Wow!

Nice to read such things... specially after 10 months of taking Aranesp every 2-3 weeks...

[Larisa]

 I saw earlier the original paper where they described the results of study of Amgen's drug on prostate cancer patients, which, I believe, was stopped prematurely because of the increased death rate in the drug group...

Everything has its own risks including life per se...

Important thing here is to use it on "as really needed" basis with no abuse.

[Kelly_Marie]

I was one of  the first entered in the trial in 1996- using Amgen and Procrit shots 2 times daily for 4 months.  According to bloodtests they really worked in increasing white/red blood cells.  I thought at that time it held back the number of platelets and blood transfusions I had.  Now I don't know?  Anything on long term damage?

Thank you,
Kelly

[Deb]

I saw this article when it came out. I had Aranesp several times so the article was of interest. I plan on discussing this with my Oncologist the next time I see him. But since the article noted that the concern was in use of elevated doses of the drug there is probably nothing to worry about, at least for me.

Thanks for the post Mary

Deb

[Rene]

I was a bit alarmed when I saw this article, mostly because I'm still taking Procrit. In the last 9 months I've taken it a total of 12 times. I only get in when my counts are really low. I've not had many side effects other than a little heart flutter for about 5 seconds a few times. I see my oncologist tomorrow and will ask him if I should be worried. As with any medications, like chemo, there are risks. Sometime the benefits outway those risks.