2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC7390

Submitter :

Mrs. Susan Hunter

Date & Time:

03/06/2006 03:03:10

Organization :

Mrs. Susan Hunter

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

Hello,

I have used HRT for 10 years to manage pre-menopausal, then menopausal hormonal symptoms. I was first perscribed Premarin by a female physician who knew of no other options and had a drug representative who did a great job of keeping her in stock of samples. I know this because I had interviewed to be a sales rep and knew the regional person. My side effects were so much worse than the original symptoms I had sought help with, that I returned to try another type of low dose birth control pill. My symptoms were depression, low energy (very unusual for me) and irritable bowels. The next pill was no better, but I decided to give it a better chance since the last try was for only 3 weeks. I tried this pill for 2 months but stopped because I knew it couldn't be good for me. I preferred my occational night sweats to the gloom this drug had created in my body. I moved to another town and found a new physician. She introduced me to the concept of bio-identical and told me there was a new compounding pharmacy in town. My doctor called the pharmacist and made an appointment for me. She told me that the three of us would work together to find a solution to my hormonal inbalance, working with choices of hormones as well as doseage. Blood work was done as a basis for this team work. My symptoms and the results of the blood work were the basis for my hour long appointment with my pharmacist. I had already researched Premarin and knew that it was synthesized from pregnant mare's urine, therefore assumed that such a foreign substance with a non- compatible molecular structure would understandably cause potentially harsh side effects. I didn't want to go through that again, so I asked detailed questions about how bio-identical hormones were derived and what type of side effects would potentially cause. I learned from the pharmacist that the molecular structure of the hormones derived from plant base was identical to ours and that symptoms were indicators of a posible need in doseage change. Possible symptoms were listed and I decided to give it a try. This was 6 years ago and I have weaned myself down to low doses every other day. I'm a very healthy, balanced and active 54year old who has hard evidence that the drug company,Wyeth Pharmaceuticals, cares more about keeping their nitch marked than they do about me as a healthy individual. Of course, that's such a given!! Guess a woman just has to be a thinker and not a follower. I have my yearly doctors appointment tomorrow morning....this is wonderful timing. I've printed all of this for her awareness so she can advocate for us and not for Wyeth.

Thank you for giving me the opportunity to share my success with bio-identical hormones, and my disdane for Wyeth.

Respectfully,

Susan Hunter

montana309@hotmail.com