The FDA has finally taken on the compounding pharmacy industy for misleading and unsubstantiated claims made in marketing so-called “bioidentical” or natural hormone therapy.
In warning letters to seven such pharmacies, the FDA cited them for making unsubstantiated claims that their hormonal formulations are safer than FDA-approved formulations. They’ve also challenging the use of estriol, an estrogen formulation never approved for use by the FDA for hormone replacement.
Estriol is a form of estrogen found in the body, along with estrone and estradiol. Estriol is a weaker estrogen than estradiol, leading its proponents to claim it is safer than estradiol, the most commonly used bioidentical estrogen, and the one found in many FDA approved products such as patches, creams and pills. There is no data to prove that claim. Estriol binds to estrogen receptors, can stimulate both uterine lining and breast cancer cells, and if used in high enough doses, probably has the same risks as conventional estrogen replacement.
I am disappointed that the FDA stopped short of assuming regulatory power over these pharmacies and is not requiring them to include standard patient information and warnings for estrogens when these drugs are compounded.
What still upsets me is that it took a so-called “citizen’s petition” from Wyeth Pharmaceuticals to get the FDA to take action. Wyeth manufactures Prempro, the HRT formulation studies in the Women’s Health Intitiative, the study that put the nail in the coffin for HRT’s use for heart disease prevention.
I’ve said it before and I’ll say it again – Wyeth’s involvement in the battle allows the multi-billion dollar anti-aging industry to frame the battle as the little guy (them) against Big Pharma. This is not a battle for Wyeth – it is about informing women.
The seven companies targeted by the FDA are –
Panorama Compounding Pharmacy
Saint John’s Medical Plaza Pharmacy
Murray Avenue Apothecary
Village Compounding Pharmacy
Pharmacy Compounding Specialties
Reed’s Compounding Pharmacy
Pacifica Pharmacy
These pharmacies appear to be taking the warning seriously – When I checked their websites tonight, all but one was either offline or had taken down their information on hormone replacement.
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FDA information on compounded hormones
It’s about time.
I received a prescription from my doctor to aid an anal fissure. It was called diltiazem topical ointment 2%. It could only be filled at a compound pharmacy. But now I’m a little concerned. The compound pharmacy I used is one of the 7 that was listed as getting warning letters from the FDA. Was the medicine I received considered alternative? It seemed to have worked.
rosie – The seven companies listed are being cited for false claims theya re making on their websites, and for dispensing Estriol, a drug not FDA approved for use as HRT. The FDA has not expressed any concerns about their ability to compound prescribed drugs.
Congress’s and the FDA’s proposed reforms would have threatened ALL compounding. As someone with severe allergies, I depend on some compounding in order to treat common illnesses due to the “approved” formulations that use cheap allergenic substances.
Pharmaceutical companies lie. Why should compounders be any different?
mlo-
I have no problem having the compounding industry compound meds that are not available in certain forulations for special conditions or patients who have issues such as allergies, etc.
But they have to play by the rules – and the rule is, if you use a drug, you must inform patients of thoe risks,and can’t spout lies on your website.
The problem was the way the rule was written. This is a common problem with all gov’t agencies. I just don’t believe enforcement came from anywhere other than a very big monied pharmaceutical company. (That seems to be just about the only time the FDA does anything anymore. Maybe I’m getting overly cynical due to such recent fiascos as the dog food scare?)
Geez – Wyeth started this nonsense because the sales on their huge money-maker “PREMARIN (PREgnant MARe’s urINe)got toppled over when the Women’s Health Initiative Study proved how bad SYNTHETIC hormones are for women. And all those women then started asking for human – instead of horse – hormones. Wyeth didn’t want to lose their profit share.
There is plenty of medical evidence out there for anyone who takes the time to read through all the studies, to see that Bio-Identical hormones ARE safer and a better choice for women (and men) who need hormones. If your doctor hasn’t familiarized him or herself with these facts, then maybe it’s time for you to get a new doctor! All Bio-Identical hormones are FDA approved – like Prometrium, Climara patch, Alora, FemPatch, Androgel, Vivelle-dot, Estraderm, Estring, Esclim – to name just a few, as there are many more. The problem is that most of these one-size-fits-all medicines don’t work for everyone. Each person should be dosed hormones based on their weight, age, medical history, hormone levels and many other factors – no 2 people are alike and shouldn’t be treated as though they are!
Thank goodness for the compounding pharmacists in this country and around the world who still believe in INDIVIDUAL, ONE ON ONE, PATIENT CARE! The kind of care that we used to get from our doctors many years ago.
I say, get educated, read the studies – there are LOTS of them. And Wyeth and the FDA both know it because they have put many Bio-Identical hormones on the market already – at least, the ones from the big Pharmas.