Is Prometrium Safe?

Tonight Channel 9 News Australia ran a story about a new approval for an old drug Prometrium by the TGA. As of Thursday 1st September it will be available as an HRT for menopausal women.

For the full story click here. 

It’s a pill to help fix the menopausal symptoms that women suffer and the story was very compelling and even made me want to go out and buy it. Interestingly though the side effects which weren’t really mentioned.

All hormone replacement drugs, whether synthetic or bio-identical will have side effects and Prometrium’s were glossed over a little bit. So with my alarm bells up, a mate calling me to ask my opinion and a patient texting me, I thought I had better delve a little deeper.

I need to state here that I have no vested interest in putting prometrium down or promoting prometrium.

If it helps women – great.

My interest is seeing women be empowered and have all the information they need to make an informed decision about any drug before using it and to consider the natural options first. Our bodies are natural after all, not robots.

Also to this day, I have written four books on hormones (all published) and have a book on Menopause and hormones. In it, Menopause, True there were side effects, I discuss the use of natural options, bio-identicals and HRT. I also have a natural hormone clinic based on the Gold Coast and have been consulting women for over 14 years with menopausal issues.

Menopause is a natural time in a woman’s life!

Menopause is a natural time in a woman’s life and can be managed naturally although sometimes it is a real challenge.

Statistics show in Australia that six in ten women have symptoms and for many it can be quite debilitating.

Common Symptoms of Menopause include:

Flushes that wake them up incessantly throughout the night, insomnia, exhaustion, weight gain and a sex drive that goes out the window. Depression and anxiety are also common complaints. I have had women suffer up to 30 flushes a night and would do anything to stop them.

I totally understand why women want to bypass these symptoms. I get it. However what we are missing here is that it is a natural time in your life (if you are a woman) and is not a disease nor a condition.

Your body was designed to balance itself. To go from a fertile state to an infertile one seamlessly.

We have to step back and look at the bigger picture of why women are not transitioning through menopause as well as other countries.

Why are we having all these problems here? I am not going to focus on the big picture now.

I have other blogs on my website that give you tips about natural remedies for flushes, weight gain and even a 7 day program on how to bust through menopause (it includes video tips, a copy of my book and a hormone module for the Happy Female Formulae). All that information is there for you to access on my webpage (in blogs and shop), so in this blog I want to focus on prometrium, the potential side effects and the things that may be over looked when it is started.

And I might add here that symptoms are not always due to a drop in hormones such as estrogen or progesterone. Sometimes estrogen goes up and this can mimic the symptoms of low estrogen. And a drop in testosterone can also cause flushing. In my clinic I use saliva testing as it is recommended by the World Health Organisations and can give a more accurate picture.

What is prometrium?

Prometrium is derived from yams, therefore is considered to be bio-identical. Bio means of the body and identical – similar to our body.

Therefore it’s not a chemical. It is from another living source.

What is prometrium indicated for?

It will be available in Australia on PBS from the 1st September for the following 2 indications:
100mg and 200mg
1. For abnormal periods or secondary amenorrhea
2. HRT – adjunctive use with an estrogen in postmenopausal women with an intact uterus (ie who hasn’t had a hysterectomy).
NB for full indications check page 6 of the TGA approval prometrium and Product Information.

Now a few alarm bells go off for me with the HRT indications.

This drug has been around many years and the research shows that women do increase their risk of certain cancers in combined HRT use. The WHI study published in 2002 saw HRT use drop by 50% due to it demonstrating women increased their incidence of breast cancer. It was the combined use of HRT (progesterone + oestrogen replacements) and this is the current indication.
I am not too sure if the news report was indicating that it will probably be used with out oestrogens, ie not as an adjunct. I really can’t tell nor know how it is being promoted.

What are the side effects of Prometrium?

There are many side effects such as dizziness, joint pains, cramps, headaches and the like.

The more concerning thing for me is the use with other HRTS. The warnings are loud and clear with this: combination therapy can cause cardiovascular disease, blood clots and stroke and even dementia. ON it’s own it may not cause breast cancer but past research shows with combination it can.

Who should avoid Prometrium?

The contra-indications are (which means it should be used in women with the following):
– Sensitivities to progesterones
– Severe hepatic dysfunction (and I would assume fatty liver)
– Undiagnosed vaginal bleeding
– Carcinomas of the breast or genital tract
– A history of clotting issues
– And more.

For a full list check out page 6 of the TGA approval prometrium

To get this drug you need to see a doctor and they should spend 15-20 minutes asking you these questions, finding out your past history and taking your blood pressure. And determining if you are at a risk of stroke and in which case the drug won’t be suitable for you.

I have seen women first hand have strokes while on the pill – which is the same as HRT. Synthetic Progesterones are well known to cause blood clots and strokes and this can lead to death.

When I was a nurse on the neurosurgery ward in a Melbourne hosptial we had a young lady have a stroke due to her pill and being over weight. She was only 28 years old and it has stuck with me for ever. Her whole life changed due to a supposedly “safe” pill. Strokes do occur. They just don’t make the news.

People need to be aware of the risks.

The use of prometrium in women over the age of 65 is not studied according the product information guide.

Summary

Now I am not saying the drug is good nor bad. And I have already stipulated I don’t have a vested interest either way.

For some women it will help a lot.

I would like to see women support their bodies with food and exercise regardless of whether they take medication or not.

Powerful foods are green leafy vegetables that are full of phytoestrogens and anti-oxidants, beetroot, flaxseeds.

There are many herbs that will help your body transition such as St Mary’s thistle, Chaste Tree and Zizyphus.

Exercise such as resting, restorative yoga and daily walking will help balance your body.

I call activities that balance your hormones green light activities and these help too.

If you have excess weight look into weight loss programs, ones tailored for menopausal women. I have put one together just for women in menopause because weight gain in menopause is not the same as other times in your life and it takes a different approach to lose it.

If you have a fatty liver then definitely see a naturopath who will have a few tools in their kit to help.

Start with eating better, doing menopause specific exercises, be informed about what you are taking.

Maybe try these routes first and if they fail, then turn to a medication, bio-identical or otherwise.
Remember this is a natural time, not a disease. Your body will transition through.
Good luck and if I can help any other way drop me an email.

Warm regards

Sam xox

PS the link to my 7 day Bust Through Menopause Program is here.

PSS: If you are not sure if you are going through menopause, take my 60 second quiz here.