2005P-0411
FDA Comment Number : EC824
Submitter : Ms. Anne Lilley Date & Time: 02/03/2006 05:02:43
Organization : Ms. Anne Lilley
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I was placed on premarin after having a hysterectomy at 36. I was miserable and depressed, I gained weight, retained fluid, had severe changes in mood and personality and lost my sex drive entirely. I deeply regretted my decision to have a hysterectomy. Even though I had been in severe pain, the pain was a better option for me. Bioidenticals have given me my life back.
As a NP I am well aware of the studies that have been done on premarin and the risks involved. Further studies need to be done on bioidenticals, as well, but the fact of the matter is that you cannot extrapolate the data for premarin to bioidenticals. Premarin and Prempro are very different drugs, with very different chemical structures and compounds included. The evidence so far has not convinced me that my health is endangered by using bioidenticals. Many of my patients are taking bioidenticals with great relief of symptoms. They are being monitored carefully and are usually prescribed by a woman's health care physican, PA or NP.
I am however, convinced that Wyeths profits are endangered.They continue to market premarin in lower dose formulations with reccomendations for short term use. I cannot believe that Wyeth Pharmaceuticals has stooped so low to try to protect it's profits. Please do not allow this to happen. I for one will not take this lying down.