Compound Hormone Therapy

Hormone replacement therapies are often used to help relieve some of the symptoms associated with menopause. Traditional hormone replacement therapies include estrogen, progestin or progesterone. The only FDA-approved therapies are those containing progestin only, estrogen only or a combination of estrogen and progestin. Currently, online companies are aggressively promoting BHRT hormone replacement therapies as beneficial to menopausal women. According to the Food and Drug Administration, the majority of these compound therapies are ineffective and some may even be dangerous.

Compounding

• Compounding occurs when a pharmacist combines or alters drugs in order to custom tailor a medication for a specific patient. Compounding is ordered by a patient's physician. Compounding can be as simple as removing preservatives or dyes. Or it may involve combining two different drugs to make one new drug. The safety and effectiveness of the new compounded medication depends on the quality of the pharmacy, the care taken during the compounding process and the qualities of the drugs used to make the new drug. The Food and Drug Administration warns that when "pharmacy compounders both operate like drug manufacturers and engage in high volume distribution, the risk of patient harm increases" (see Reference 1).

Compounded Hormone Therapy

• The FDA has issued warnings against using compounded hormone therapies that are often referred to as bio-identical hormone replacement therapy (BHRT). The term "bio-identical" is not recognized by the FDA and the definition differs according to the user. Some promote the term as meaning "all natural plant derived hormones," while another uses the term to define compounds that have the same "chemical and molecular structure" as hormones produced by the body (see Reference 1).
  BHRT therapies often contain an ingredient, estriol, which is not approved for use by the FDA. Other common BHRT ingredients include estrogen and progesterone. In most cases, it is illegal to use estriol as a part of a compounded drug. The FDA states there is absolutely no evidence the compounded hormone therapies work or that they are safe.
  Another concern is false or misleading claims. Many manufacturers promise compounded therapies will help prevent stroke, cancer and debilitative diseases such as Alzheimer's. The FDA has sent warning letters to seven companies the agency believes are guilty of making misleading or false statements regarding BHRT products (see Reference 2). However, more and more BHRT companies are popping up on the Internet. Problems in protecting consumers from these companies include a lack of federal requirements. BHRT companies are not required to register with the FDA or to report on the products they manufacturer (see Reference 1).