OCTOBER 01, 2006

Consumer activists with the lobby group Public Citizen are warning women to avoid hormone replacement drugs compounded by pharmacists. According to officials at Public Citizen's Health Research Group, women should be "especially wary of all so-called bioidentical hormone replacement therapy (HRT) drugs compounded by pharmacies due to the safety issues and their lack of FDA regulation."

"The FDA has done nothing to warn women about the dangers of compounded HRT drugs," said Health Research Group Director Sidney Wolfe, MD. "This is yet another example of the FDA's failure to fulfill its mission of protecting the health of American patients."

The organization's warning about pharmacist compounding drew a strong rebuttal from the American Pharmacists Association (APhA), which said that the criticism "overlooks the value compounding pharmacists provide to their patients, including their extensive knowledge about medications."

According to APhA, compounding serves an important purpose because "millions of Americans have unique medical needs that cannot be met by mass-produced products. Some patients need extremely low dosages, liquid dosage forms, or combinations of ingredients that are not available from manufacturers."