03/05/2013
This past week there has been a lot of news emanating from the FDA that concerns menopausal and perimenopausal women. I would like to share some of this with you.
A week ago the FDA, without using an Advisory Panel of outside experts, approved Ophena (generic name Ospemifene) for “treatment of moderate to severe dyspareunia (medical term for painful intercourse) a symptom of vulvar and vaginal atrophy due to menopause (the vaginal changes seen with no more estrogen production)”. This is extremely important for women. Previously there had been no FDA approved non estrogen agent whether local or systemic for such an indication. Ophena is a SERM (selective estrogen receptor modulator). Other SERMs for other applications include Evista (for osteoporosis and breast cancer prevention) and Tamoxifen (for breast cancer patients and breast cancer prevention). The FDA decided to include language in the boxed warming for Ophena in which they state “in the endometrium (uterine lining) Ophena has estrogenic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen”. I am somewhat disappointed and almost shocked at this statement. I was involved in the studies of uterine safety for a number of SERM compounds. This drug is similar to raloxifene, which has been proven to be extremely safe in the uterus. The FDA has labeled this drug like estrogen which by itself can be a problem in the uterine lining. This is not appropriate nor is it borne out by the data for Ophena. I’ve been asked to write an editorial for the journal Menopause and have explained this with scientific backup and appropriate references.
Furthermore the labeling for Ophena states that it has “not been adequately studied with breast cancer therefore should not be used in women with known or suspected breast cancer or with a history of breast cancer”. This borders on unbelievable. While I agree with the first part of that statement, that there are not yet adequate studies, every SERM adequately studied thus far has a reduced breast cancer risk, and none of the others have suggested any harm in the breast. As a clinician there is a large unmet need for an agent to treat painful intercourse due to vaginal dryness and atrophy in women who cannot, should not, or will not use estrogen products; and this is exactly those with a history of breast cancer or at high risk for breast cancer. In my opinion this is the ideal group for such a new agent as Ophena. Based on class labeling a statement about not using it in such patients is in my opinion unfair and not appropriate.
OTHER NEWS
Yesterday, an advisory panel of the FDA recommended against approval of two non-hormonal drugs specifically designed to treat vasomotor symptoms (hot flashes, night sweats). Both of these have been around in other forms for quite some time and many of my patients use them, especially gabapentin (also known as Neurontin). One of the reasons they advised against approval was apparently because they claim the medications are already available (although its use is “off label”). The new form was a sustained release version, instead of needing to take up to 3 to 4 doses per day. This underscores the conundrum of our current system. Some physicians, like myself, who follow the scientific literature closely, are aware of its utility. For some of my patients this medication has been a Godsend. However, most physicians do not follow the scientific literature so closely. They rely on marketing and publicity to inform them of new developments. Without FDA approval, and “on label” marketing, most physicians are not aware of the existence of this application for gabapentin. The other drug not approved is a lower dose of Paxil, the antidepressant. The use of ½ strength antidepressants for hot flashes has been tested and became popular initially in breast cancer patients on tamoxifen who obviously cannot take estrogen for hot flashes or night sweats. Once again, however, most physicians are not aware of this and only with FDA approval would publicity and marketing be possible.
I am disappointed by much of the above posture of the FDA. As always I will stay on top of scientific developments in an attempt to deliver world class gynecologic care based on science not politics.
This post was last modified on August 3, 2022 5:47 pm