Flurry of FDA action against aromatase inhibitor supplements
If you’ve ever met me, you’ll know that I’m not a bodybuilder. That’s why I was taken aback earlier this year when I learned that men are taking aromatase inhibitors – and not for breast cancer.
This education came to me when I was asked by a network news program to comment on a litany of drugs and supplements found in the possession of self-proclaimed guru James Arthur Ray following the Sedona sweat lodge deaths at one of his “Spiritual Warrior” retreats. Among the bodybuilding supplements and testosterone replacement drugs authorities found in his possession was anastrozole (Arimidex), for which he had a valid prescription.
Strategies to increase testosterone in men – indirectly or with direct testosterone supplementation – run the risk of causing feminizing side effects. The goal in these settings is to prevent gynecomastia and testicular atrophy by preventing testosterone from being aromatized to 17β-estradiol or androstenedione from being converted to estrone.
So, no, my pharmacist friends: the rash of aromatase inhibitor prescriptions you’re filling for men does not indicate an epidemic of male breast cancer – normally only 0.8% of breast cancer cases.
Earlier this month, I noticed that the US FDA announced a series of “voluntary product recalls” from supplement manufacturers whose products contained an aromatase inhibitor, 1,4,6-androstatrien-3,17-dione, or ATD. The compound has also been cited under the names 6-etioallochol-1,4-diene-3,17-dione, 1,4,6 etioallocholan-dione, or 3,17-keto-etiochol-triene.
Due to the unusual regulation of dietary supplements in the US, when such products contain an undeclared drug or other agent not classified as a dietary ingredient, FDA usually encourages companies to recall their product and issue a warning to consumers. Five such warnings came out between September 13 and 16, leading FDA to issue a summary warning on September 20. The full text and links to the five warnings can be found here but this is the general issue in FDA’s language:
ISSUE: Products marketed as dietary supplements contain aromatase inhibitors, commonly known as “ATD.” Adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events.
BACKGROUND: The FDA concludes that products containing aromatase inhibitors have a reasonable probability of resulting in permanent impairment of a body structure or function in at risk consumers. FDA has notified manufacturers that these products do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.
The FDA alerts cover the following products and I’ve put the links here so readers can access the individual recalls and warnings: Advanced Muscle Science (Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol), ArimaDex, Clomed, Off Cycle II Hardcore, and iForce – Reversitol.
Each of the FDA warnings note that none of the five companies have received any reports of adverse reactions – note wording that adverse effects “could include the following…” Therefore, it’s not yet known if any of the products contain enough ATD to cause side effects.
The widespread use of these products and these recalls obviously have no impact on off-label prescribing of AIs. However, clinical trials are ongoing for the use of AIs in andropause or hypogonadism in elderly men, male infertility/obesity-related oligospermia, and improving insulin sensitivity in obese men.