Posts made in June, 2010

This Just In! FDA Advisory Panel Unanimous Against Flibanserin

Posted by Liz on Jun 18, 2010 in sexual desire, sexual health | 0 comments

The verdict’s in! The Reproductive Health Advisory Committee did not consider flibanserin, the female Viagra equivalent, to be any more effective than placebo.

Shocking eh?

Here’s the AP report. And more information from this morning’s post on Flibanserin.

Female Viagra hits a new low in the bedroom

Posted by Liz on Jun 18, 2010 in sexual desire, sexual health | 4 comments

I was going to devote another post to “Low T’ and male “menopause” today.  Check back on Monday for that because the early news out of the Food and Drug Administration, whose Reproductive Health Advisory Committee is set to meet today to decide on a final verdict, is that flibanserin falls short of its promise to improve women’s sexual desire. Citing issues with the manufacturer’s data, the FDA says that studies do not show significant improvement in a woman’s sexual desire and also fails to note the significant side effects associated with flibanserin, including depression, dizziness and nausea. The ultimate decision could possibly deal a huge blow for profits that could exceed $2 billion dollars.

Importantly, it appears that hype about flibanersin (and more specifically, low sexual desire) has reached a new low. Not only have the company’s marketing efforts pushing the “fact” that one in 10 women suffer from low sexual desire (this figures varies in the medical literature), but the company even funded a Discovery Channel documentary to promote greater awareness of the disorder, a documentary that featured company-paid experts and was reviewed by the company before it aired.

As I’ve written time and again, low sexual desire is a serious and troublesome problem in women that can significantly affect quality of life, self-esteem and relationships. Some experts dispute that female sexual disorder even exists (although clinical experience in postmenopausal women speaks otherwise). However, whether or not you believe in low sexual desire, one thing remains true: when it comes to sex, women operate on a different plane than their male peers. Studies have shown that sexual desire in women is highly reliant on context, experience and personal attitudes. Therefore, you can’t simply fix the symptom without exploring underlying contributing factors.

Do we need another pill in the bedroom? Do we need a female viagra?  I hope that the FDA Reproductive Health Committee tells Boehringer “no.”

Wednesday Bubble: HRT – wait a moment!

Posted by Liz on Jun 16, 2010 in HRT | 0 comments

Back in early May, I wrote a post about the difficulties in stopping hormone replacement therapy (HRT) and the disturbing fact that doctors have no guidelines to follow in order to advise their patients on the best strategies. Today’s Bubble is a perfect companion to that piece, as it addresses the fact that research now shows that women who start HRT and then stop it have a tendency to have significantly greater and more severe  menopausal symptoms than had they never started HRT at all.

Writing in the online edition of Menopause journal, researchers say that among 3,496 postmenopausal women who completed a pre- and post- stopping therapy survey during the Women’s Health Initiative study (a trial that compared estrogen/progestin to placebo and was subsequently halted when HRT was found to double the risk of breast cancer) :

• Those who had not reported having hot flashes at the start of the study were more than five times as likely to report moderate to severe hot flashes after stopping HRT compared with women with no symptoms who took sugar placebo pills. However, women who had reported having hot flashes at the study’s start were only slightly more likely to report hot flashes after stopping HRT
• A similar pattern was seen for night sweats, i.e. women who had none at the study’s start were almost twice as likely to report them after stopping HRT
• Age at stopping HRT was increasingly associated with more joint pain, i.e. the older the woman, the higher the risk for experiencing joint pain

The researchers say that although there have been previous reports of  a surge in vasomotor symptoms like flashes and sweats after stopping HRT, these findings show that estrogen, either alone or with progestin, may promote symptoms when HRT is stopped, even if a woman was not experiencing them when she started therapy. More specifically, the risk for menopausal vasomotor symptoms and joint stiffness is four to seven times more in women with and without prior symptoms when HRT is stopped.

The takeaway message is that it’s not only important to consider the health risks associated with HRT but also, what happens when you stop it. Clearly, even if your symptoms disappear while on HRT, your risk for symptoms after stopping therapy is fairly high.

You should always weigh the risk benefit ratio before starting any type of therapy. HRT may not be worth the trouble. Or the multiple risks.

p.s. More on this study from my friends at Reuters Health.

Is topical HRT hurting your pet?

Posted by Liz on Jun 14, 2010 in HRT | 2 comments

File this one under “OMG.” I ran across a piece this past weekend that discussed the effect that topical hormones, particularly HRT, might be having on your pets. Although experts from the North American Menopause Association (NAMS) are quoted as saying that they’ve not heard of this before, the reporter  uncovered five years worth of discussion on veterinary internet boards. Evidently, vets are seeing female animal patients with swollen vulvas and male patients with enlarged mammary glands and smaller than normal penises.

It appears that exposure occurs when owners apply topical hormone gels, lotions and sprays to the arms (i.e. elbows, wrists) and legs and then handle or snuggle with their pets. The problem has also been associated with pets unwittingly licking the areas where owners have applied the drugs.

Evidently, the Food and Drug Administration is looking into this as is the NAMS. In the interim, if you are using topical hormones, you might want to be more careful where you apply them (e.g. inner thigh or abdomen) and be sure to wash your hands before handling your pets.

And if your animal is exhibiting unusual signs? Bring them into the vet immediately.

Has anyone encountered this before? I’d love for readers to weigh in.

Wednesday Bubble: The HRT patch – is it safer?

Posted by Liz on Jun 9, 2010 in HRT | 9 comments

Remember the diva and the doctor sitting on the roof espousing the benefits of the HRT patch? Well, it turns out that some of these patches might not be so safe after all. Results of a study of over 75,000 women published in the British Medical Journal, show that the use of high-dose transdermal (through the skin) HRT patches increases stroke risk by as much as 88%.

Granted, transdermal or through the skin delivery bypasses the liver, which typically makes patches safer than their oral counterparts. However, if the drug isn’t safe, well, then the patch might not be either.

In this latest bit of news, researchers evaluated women between the ages of 50 and 79 who had participated in the ongoing Study of Women Across the Nation (SWAN). Every woman who had had a stroke were matched for comparison to four women in the study, with similar characteristics, who had not. The women were further divided into groups based on their use and type (i.e. oral or patch) of HRT, including estrogen only, estrogen plus progestogen, progestogen only, and the estrogen alternative, tibolone (which is not available in the US).

The researchers say previous and recent studies suggest that oral HRT, including estrogen only or estrogen plus progestogen, is associated with a 30% increased risk of stroke. However, stroke risk differs between high- and low-dose patches. Overall, they report that:

• Low-dose patches do not appear to increase stroke risk, at least in the short-term (they say that they cannot rule out an increased risk with long-term use)
• High-dose patches, regardless of whether or not they are estrogen only or estrogen plus progestogen, appear to increase stroke risk by anywhere from 25% to 88%
• Risk was the highest among women who had used oral HRT before trying transdermal HRT, although this risk appeared to decline the longer the time period between stopping oral and starting the patch
• Findings remained even after adjustments were made for factors that might influence results, including age

What the findings mean

Despite claims to the contrary, it does not appear that HRT offers much protection against heart disease during and after menopause. What’s more, the HRT patch may not actually be safer than oral HRT, at least in so far as the high-dose HRT patch goes. Although the researchers state that they were unable to distinguish between types of stroke when evaluating the SWAN study data, they say that these data show the need to look further into how HRT is delivered, especially as use of the HRT patch becomes the norm.

As I’ve written previously, if your doctor suggests you try HRT for menopausal symptoms, it behooves you to ask the hard questions. While you may save your sleep, mood and a few articles of clothing, you may be placing yourself at a higher risk for cancer, heart disease and other serious conditions.