QuestionDr. Ramirez-I have done some reading, and I have many questions in my mind about the safety of injections for fertility and IVF. Other than Menopur (as I understand it), it sounds as if not all of the proteins in urine-derived medicines can be eliminated during purification. What if the urine donors are to have undiagnosed illnesses? The idea of injecting a biological product raises legitimate concerns. At the same time, the recombinant formulas rely on Chinese Hamsters, bovine serum and animal products - which also raises questions. Do you have any information on urinary-derived versus recombinant medicines and their safety? Thank you.
AnswerHello Lindsay from the U.S.,
Thanks for the very interesting question. As a clinician that has used these medications for many many years, I can attest that there are no risks, side effects or long term effects that I have experienced other than hyperstimulation syndrome (over stimulation of the ovaries). However, that is not a clinical trial or adequate test. Since I am not a biochemist, I cannot specifically answer your question and concerns. Surely, the urinary forms of the medication goes through testing to eliminate all forms of transmittable disease, but who knows if there are things being missed. For example, hepatitis C was not diagnosed until 1993, yet I am sure it was around before that. It was previously called non-A, non-B hepatitis when I was in medical school. Now there are tests for it. The same goes for the AIDS virus. Some diseases we cannot know because we don't have the technology to test for it. That being said, urinary gonadotropins have been used in the world since the first IVF 30 years ago and there have not been any reports of recurrent infectious, genetic or other types of disease. The same goes for recombinant medications, which although have not been around for as long, have been around for at least a decade. Many many pharmaceuticals use an animal host to produce, such as vaccines. There is very little risk of transference of an animal based disease through these methods. So, as far as I know, there is minimal risk, but who can know for sure? This question would be best put to a biochemist in the pharmaceutical industry. The FDA might also have some information regarding this since they are the ones that have to approve all medications for human use.
Good Luck,
Edward J. Ramirez, M.D., FACOG
Executive Medical Director
The Fertility and Gynecology Center
Monterey Bay IVF Program
www.montereybayivf.com
Monterey, California, U.S.A.
for additional information check out my blog at http://womenshealthandfertility.blogspot.com check me out on twitter with me at @montereybayivf and facebook @montereybayivf
