2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC1674 | |||||||||||||||||||||||
Submitter : | Dr. Pamela Svendsen | Date & Time: | 02/13/2006 01:02:42 | |||||||||||||||||||||
Organization : | Family Medicine Associates of the Gulf Coast | |||||||||||||||||||||||
Category : | Health Professional | |||||||||||||||||||||||
Issue Areas/Comments | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
Dear Sir or Madam,
I am writing in regards to the Wyeth effort to limit the prescription and sale of bio-identical hormones. As a physician, I have seen the differences between synthetic and BHRT in countless female patients. Synthetic hormones alleviate certain symptoms for women but bring with them numerous unpleasant side effects, including increasing the risk of stroke and heart attack in users. BHRT, on the other hand, has proven to be safe and effective without the untoward side effects associated with synthetic hormones. There are numerous compounding pharmacies which provide pure, effective products for our patients. Please do not allow Wyeth to interfere in my relationship with my compounding pharmacy and, most importantly, my patients. As a physician and a woman, I would be outraged if you took away this safe and effective therapy for countless women in the country. Sincerely, Pamela J. Svendsen, MD | ||||||||||||||||||||||||