Prometrium, Lupus and Blood Clots

Dear Catherine,

I just finished reading the info on the Natural-Progesterone-Advisory-Network.com site and although it sounds great you fail to mention one very important thing. The blood clots related to lupus and progesterone. I swear by Prometrium. It agrees with me undeniably however my pharmacist said “DO NOT take Prometrium with lupus”. lupus comes with blood clots and so does Prometrium (progesterone).

People can die. Why is this not mentioned?

Please let me know as I am very interested. I suffer from excrutiating pain in my joints from Lupus and would LOVE to take progesterone. I also suffer from seizures and progesterone mellows me out; I am estrongen dominant. So you see progesterone is ideal for me except for the fact that it can kill me.

Please let know if you have information that I do not.

Warm Regards,
GP

Catherine Responds

Your email to me today corresponds with another I received which I’d like to share with you. Kay writes, “I have a seizure disorder that had me down ~18 days/month. I was started on compounded progesterone cream - seizures went down to ~5/month. This is the first time I may have hope of regaining my life!”

Progesterone has been used in a number of clinical applications since 1940. Its early use was to assist women with infertility. Progesterone has NOT been linked to increased cancer risk. In fact, a large study conducted in France to look at the risk of breast cancer with hormone replacement therapy found that using bioidentical progesterone did not cause any increase in breast cancer, whereas use of synthetic progestins did result in a statistically significant increase in breast cancer risk.

It is important to note that progesterone is often confused with progestins, which have been linked to increased cancer risk as evidenced in the Women’s Health Initiative (WHI) and also in this large French study.

The WHI was a landmark women’s health study that when reported by the government had wide (and detrimental) impact – creating mass fear for women about hormones, and forever changing practitioners prescribing of hormones. The WHI study was abruptly halted in July 2002. The initial findings of the study showed that women taking synthetic combination HRT (e.g.Prempro) had an increased risk of heart disease, breast cancer, stroke and blood clots.

In January 2003, the FDA required that the highest level of warning information in labeling be included with every prescription of synthetic estrogen or estrogen-progestin HRT (and all FDA-approved formulations of micronized bioidentical progesterone). The label highlights the increased risks for heart disease, strokes and breast cancer.

I find it ‘interesting’ to read that cardiovascular (and other) warnings outlined on the Prescribing Information for Prometrium relate to the WHI that reported increased risks of nonfatal myocardial infarction, strokes, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women during five years of combination therapy with conjugated equine estrogens (CEE) 0.625mg and medroxyprogesterone acetate (MPA) 2.5mg versus placebo.

I believe THAT’s where the confusion lies. Your GP has confused warnings that apply to these not-natural-to-the-body progestins (MPA) with bioidentical (natural) progesterone which was NOT studied in the WHI.

Have a look at the Prescribing Information on some brand names of FDA-approved formulations of micronized progesterone (vaginal & oral) and you can see that these warnings are pretty consistent, and relate back to the WHI findings which, I reiterate, DID NOT include bioidentical progesterone: Crinone, Endometrin and Prometrium.

But warnings are not limited to FDA-approved drugs. In the State of California, progesterone creams sold over the counter must come with a warning even though there is no evidence that bioidentical progesterone is linked to cancer.

Suffice to say, the information stream has been “muddied”. The end result - mass confusion and misinformation. Emails like yours prove women and their healthcare professionals are bamboozled. But if we’re SMART enough - and dogged enough - to pull the FACTS together, we see the smoke and mirrors for what they are.

Not only is there a lack of adverse effects of bioidentical progesterone on the cardiovascular system, but there is evidence of beneficial effects.

Bioidentical hormones have been available for over 30 years in the USA. Over the past decade, forward-looking health care providers have used bioidentical hormones with great success—a finding confirmed by several U.S. and European research studies, and further supported by the exceptional improvements observed in patients.

One of our readers kindly offered the following comment on the success of progesterone in the treatment of lupus. She writes, “The addition of natural progesterone cream has taken care of at least half of the symptoms related to lupus. Interesting, huh?”

But is oral the best delivery system for you?

Oral hormone replacement therapy post-menopausally has been associated with an increased risk of stoke due to thromboembolism. This randomized, placebo-controlled study evaluated the differing effects of oral and transdermal estrogen/progesterone therapy or placebo on hemostasis. Oral, but not transdermal therapy was seen to increase the susceptibility of clotting in healthy post-menopausal women 45-64 years. The authors concluded that route of administration of hormones can affect the incidence of clotting, with oral hormone replacement increasing risk, and transdermal hormone replacement demonstrating no negative effect on clotting.

Another randomized crossover study comparing topical progesterone cream (Pro-gest®, 40 mg twice daily x 12 days ) with oral micronized progesterone (Prometrium®, 200 mg daily x 12 days) indicated that equivalent blood levels of progesterone can be achieved with substantially lower doses of topical progesterone cream than with oral micronized progesterone.

Transdermal delivery of hormones (patches, creams, and gels applied to the skin) has been found to be effective and well tolerated, with the additional benefit of bypassing the first-pass effect of the liver, allowing for reduced dosages as more of the hormone is directly available for its therapeutic effect rather than being mostly metabolized.

Progesterone in a cream is absorbed through the skin, travels through the network of microcirculation, working its way into the larger blood vessels and reaches the liver where it is broken down into inactive metabolites and excreted.

Creams utilise fatty and cellular tissue as ‘reservoirs’ for storing progesterone which is why creams achieve a more sustained level of progesterone exposure. This ’storage’ was validated by Chang et al in their 1995 study utilising transdermal progesterone on women with breast cancer.

Creams use smaller amounts (doses) because it takes longer for these amounts to get to the liver and tissues are exposed to the progesterone for longer and hence have a greater capacity to take up and utilise the hormone.

Cream dosing is based around the ovary’s ability to produce between 15-20mg of progesterone daily in a normal healthy woman. Women who are exposed on a monthly basis to normal progesterone production will find their body tissues are progesterone replete. A progesterone deficient woman’s tissues are crying out for progesterone and ‘experts’ have found a dose of around 30-40mg (4% cream) daily will achieve a better and quicker clinical outcome in these women than drip feeding 5-10mg daily. Symptoms tend to settle once body tissues are progesterone replete, at which point dosing can usually be reduced to physiological levels (2% cream).

The research is there if you go looking … click here.

In light, love & laughter,

Catherine P. Rollins
Founder / CEO
Natural-Progesterone-Advisory-Network.com

“Supporting Women in their Choice of Bioidentical Hormone Replacement Therapy (BHRT)”