Drug Warnings

The FDA has put out two press releases in recent days, one that focuses on prescription sleep aids, the other on drugs that stimulate erythropoiesis (the formation of new red and white blood cells in the bone marrow).
As far as drugs like Ambien, Lunesta, Halcyon and others go, we're informed that consumers need to be advised of certain risks associated with these sleep aids:
  • Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
  • Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
Seems pretty common-sense to try herbal and other alternatives first, especially considering the cost difference.

What is even more concerning to me (and don't even get me started on cost in this case: Procrit often runs into the $2000 / month range) are the new black-box warnings for the anti-anemia drugs given to so many folks who are receiving chemotherapy. These have been touted as ways to keep red blood cell counts elevated in these patients. Some highlights:
  • Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
  • ...shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy.
  • Patients treated before surgery with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep vein thrombosis.
  • for example: "The FDA was notified in February 2007 of the final results of a double-blind, placebo controlled study to evaluate whether use of epoetin alpha in anemic non-small cell lung cancer patients not on chemotherapy improved their quality of life. The epoetin alfa dose was titrated to maintain a hemoglobin level of 12 to 14 g/dL; epoetin alfa was dosed at 40,000 IU every week. The study was terminated early when the data safety monitoring committee determined that the median time to death was 68 days in the epoetin alfa arm versus 131 days in the placebo arm (P=0.040 and the majority of deaths were due to disease progression. Also treatment with epoetin alfa did not significantly reduce the need for transfusion or improve the quality of life".
How about two excellent rooty preparations, made from cheap, abundantly growing plants, and which are certainly safer and probably more effective?

Astragalus root

Rehmannia root

An easy way to prepare these herbs is as a decoction. Using 4 heaping tablespoons of Astragalus root and 2 of prepared Rehmannia root (both available at a good herb store) per gallon of water, create a broth by simmering in a covered pot for at least an hour, better still for 3 or 4, adding water as necessary. Strain, and keep in the fridge. 12-16 ounces three times a day can be taken with meals.

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