On February 26, 2013, the Food and Drug Administration issued a news release saying that it had approved a medication called Osphena to treat a problem called postmenopausal dyspareunia (pain during sexual intercourse associated with changes in the vagina after menopause). The medical website Medscape reported that the news release had been issued. How to read these announcements? It seems as though FDA approval should be enough to know that a medication is safe and effective. However, what are some guidelines in reading and evaluating this announcement?
First, some background: After menopause, when estrogen levels decline, tissues (cells) of the vaginal lining can become thinner, drier (thus providing less lubrication during intercourse), and less elastic or flexible.
This can result in pain during intercourse, feelings of burning or soreness, inflammation, and irritation.
There are a variety of solutions for dealing with this. Regular sexual stimulation (intercourse, masturbation) is recommended to keep vaginal tissues healthy. Water-based lubricants can help reduce discomfort during intercourse. Expanded views of sexual pleasure that don’t include intercourse might work around the problem. Leaving enough time to become aroused during intercourse (extended foreplay), communication between partners about when sex is painful and when not, can also help. Herbs like dong quai and black cohosh are recommended, especially by complementary/alternative practitioners, although the herbs lack a research base. A low-dose estrogen applied to the vaginal area (as a cream, tablet, etc.), is effective. Local application minimizes estrogen being absorbed into the bloodstream, traveling through the body, and having effects, some of them potentially negative, distant to the vagina. There is, however, controversy about some estrogen being absorbed.
Now, to the FDA announcement: The FDA requires proof of a medication’s safety and effectiveness before it is approved. According to the news release: “Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.”
Notice, first, that the drug’s effectiveness was tested for 12 weeks. This is not an unusual amount of time for such a study, but it is not very much time. Notice also that women treated with Osphena had a “statistically significant” improvement. As I discussed in a previous post, “statistically significant” means “unlikely to have occurred by chance.” In other words, there was evidence that Osphena really did have an effect, but we don’t know how big an effect—it might be very large or very small.
Safety was established by studying the experiences of women for one year: however, one year is not a long time for side effects to develop. Osphena is a systemic medication. That means it is not applied locally in the vaginal area, it is ingested as a pill so that it travels to all parts of the body in the bloodstream. It is a selective estrogen-receptor modulator, or SERM. SERMs act like estrogen in some places in the body while not in others. The idea is that a SERM like Osphena would act like estrogen in keeping vaginal cells healthy while not acting like estrogen to increase health risks like certain cancers. However, more time than a year might be needed for health problems to show up. Indeed, the FDA news release stated that “Osphena is being approved with a boxed warning alerting women and health care professionals that the drug, which acts like estrogen on vaginal tissues, has shown it can stimulate the lining of the uterus (endometrium) and cause it to thicken…. Women should see their health care professional if they experience any unusual bleeding as it may be a sign of endometrial cancer or a condition that can lead to it.” The FDA announcement also stated that “Common side effects reported during clinical trials included hot flush/flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating” and that Osphena should be prescribed for the “shortest duration consistent with treatment goals and risks for the individual woman.”
In conclusion: It’s always a good idea to approach information with an alert and critical mind, to look for details, to have information about background and context, and it’s always great when you have a resource you trust to help interpret information.