Menopause Matters Forum
Menopause Discussion => All things menopause => Topic started by: Hurdity on October 10, 2019, 07:56:40 PM
-
Hi there all
There have been numerous discussions on different threads about hair loss on HRT but in particular about Vagifem with members (rightly) quoting some information from one of the commerical websites suggesting that this was a side effect.
I decided to write to Novo nordisk about this as it seemed to be at odds with the information here in UK on our own medicines database.
Rather than this response getting buried in one of these threads I thought members might be interested to read their response (they also sent some tables but think they don't reproduce well on this forum software although you can see the data), so I have reproduced it in full.
START OF QUOTE "Dear
Thank you for your recent enquiry on the following subject:
Vagifem® (estradiol vaginal tablet) 10 mcg; information on www.vagifem.com website regarding hair loss
Thank you for the information that patients taking Vagifem® have reported hair loss. We do not have enough information make any comment on whether there is a causal relationship between the hair loss and our product in these individual patients.
The www.vagifem.com website was created by our colleagues in the USA for consumers in that country and is not intended for use in the UK. You will notice that the Prescribing Information displayed on the website is from the USA.
As you may know, the regulations on the marketing of medicines in the USA are very different from those in the UK and Europe. US pharmaceutical companies can promote medicines directly to the public which is, of course, not permitted in the UK. The differing FDA requirements on the safety information that they provide when marketing their products may account for the difference in the information found on this USA website from that which we provide in the Vagifem® Summary of Product Characteristics and (SmPC) in the UK.
I see that the www.vagifem.com website includes the following:
‘What are the possible side effects of Vagifem®?'
Vagifem® is only used in the vagina; however, the risks associated with oral estrogens should be taken into account. The most commonly reported side effects of Vagifem® include: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.'
As you have correctly observed, the Vagifem® SmPC in the UK does not list hair loss as a side effect. The clinical trials and post-marketing surveillance of this product did not identify hair loss as a recognised side effect. Hair loss is a known side effect of oral oestrogen products and, as you have pointed out, can sometimes occur naturally due to hormonal changes during the menopause.
The intended meaning of the information on the USA website seems to be that the known effects of oral oestrogen, including hair loss, should be considered in relation to this product. Unfortunately, the way it is written suggests that hair loss is a recognised side effect of Vagifem®, which is not the case.
I hope the following data on the adverse effects of Vagifem® 10mcg reported from our clinical trials will be helpful.
Clinical safety
Simon et al evaluated the long-term efficacy and safety of Vagifem® 10 mcg in a 52-week, multicentre, double-blinded, randomized, parallel-group, placebo-controlled study . Three hundred and nine postmenopausal women, with moderate to severe urogenital symptoms, were randomized to Vagifem® 10 mcg (n=205) or placebo (n=104). Treatment regimen was to insert one tablet vaginally daily for 14 days, followed by one tablet twice weekly. The most common adverse events reported for Vagifem® 10 mcg were vulvovaginal mycotic infection, back pain and vulvovaginal pruritus whereas placebo-treated patients reported headaches and vaginal discharge.
A 12-week, randomized, placebo-controlled, double-blind trial was conducted by Bachmann et al in 230 postmenopausal women complaining of moderate to severe atrophic vaginitis . This study compared the efficacy and safety of Vagifem® 10 mcg and 25 mcg to placebo. At the end of the 12-week study, the women were switched to an open-label extension and treated with Vagifem® 25 mcg for 52 weeks. The most commonly reported adverse events are reported in Table 1.
Table 1. Common Treatment-emergent adverse events
Vagifem® 10 mcg Vagifem® 25 mcg Placebo
Headache 3% 9% 6%
Back pain 0 7% 6%
Abdominal pain 5% 7% 4%
Moniliasis genital 0 5% 2%
Upper respiratory infection 7% 5% 4%
Vaginitis 4% 3% 6%
Vaginal discomfort 5% 3% 0
One death and three serious adverse events were reported during the study, however none of these events were considered related to study drug.
Overall, clinical studies of Vagifem® 10mcg have found that oestrogen-related adverse effects occur at a low rate, similar to placebo, but if they occur, this is usually only at the beginning of treatment.
Endometrial Safety
A 52-week, multicentre, single-arm, open-label clinical trial was conducted in 336 postmenopausal women, with moderate to severe symptoms of urogenital atrophy, to assess the endometrial safety of Vagifem® 10 mcg .
Vagifem® 10 mcg was given once daily for the first two weeks followed by twice weekly maintenance therapy. By the end of week 52, 284 biopsies were performed. Data from this study was combined with data from 205 patients receiving active treatment in the above efficacy study by Simon to give a pooled analysis of endometrial safety for 541 women who had received 52 weeks of treatment with Vagifem® 10mcg .
Table 2. Endometrial Biopsy Results with Vagifem® 10 mcg Treatment After 52 Weeks
Baseline Week 52
Total Number of Endometrial Biopsies 537 443
No tissue 23 (4.3%) 51 (11.5%)
Insufficient Tissue 169 (31.5%) 126 (28.4%)
Atrophic or Inactive Endometrium 331 (61.6%) 258 (58.2%)
Weakly Proliferative 2 (0.4%) 1 (0.2%)
Complex Hyperplasia without atypia 0 0
Endometrial Carcinoma 0 1 (0.2%)
Polyps 9 (1.7%) 5 (1.1%)
Other 3 (0.6%) 1(0.2%)
One patient was found to have endometrioid adenocarcinoma at the end of the study. Because the screening biopsy had revealed 'no tissue' but was not repeated, it is uncertain whether the carcinoma was pre-existing at baseline. This patient had a previous history of treatment with an unopposed systemic oestrogen and methyltestosterone combination for two years. One case of complex hyperplasia without atypia was diagnosed in a patient who discontinued the study after only 9 days of trial drug exposure.
Endometrial thickness was measured by transvaginal ultrasounds in these studies. Mean endometrial thickness was 2.14 mm at baseline and remained unchanged at the end of 52 weeks of treatment.
In summary, clinical studies of Vagifem® 10mcg have not shown any serious adverse events which were considered to be due to the study drug. Studies of patients taking Vagifem® 10mcg for one year have shown no increased risk of endometrial stimulation. As a general rule, oestrogen therapy should not be prescribed for longer than one year without a physical and gynaecological examination being performed. The addition of a progestagen is not recommended with local treatment with Vagifem® 10mcg. Please see section 4.8 Undesirable effects of the Vagifem® Summary of Product Characteristics for further information.
I hope this information is of assistance, but if we can be of any further help, please do not hesitate to contact us again.
Yours sincerely,
Jackie Gilbart
Medical Information Specialist
on behalf of the Medical Affairs team
Enc.
References
Simon J, Obstetrics and Gynecology 2008; 112:1053-60
Bachman,G. et al, Obstetrics & Gynecology 2008;111:67-76
Ulrich LS, Climacteric, 2010; 13: 228-37
Simon J, Obstetrics and Gynecology, 2010; 116:876-83
Vagifem Summary of Product Characteristics " END OF QUOTE
They also sent me copies of these papers listed above.
Anyone who feels they have experienced side effects not listed should report to the MHRA under the yellow card scheme or get in touch with the company directly and it will be sent to the safety department, although post-marketing anecdotal evidence does not have the same status as trials results - but is still helpful to report.
I hope this information is of interest.
Hurdity x
-
I use ovestin and have not been advised to have a gynaecological examination after a year.
-
I use ovestin and have not been advised to have a gynaecological examination after a year.
It's not absolutely clear whether the examination needs to be after 1 year or just during the first year. I did have an examination after about 6 weeks on Vagifem by a consultant. I have since had a cystoscopy.
-
Placebo is very powerful at about 30%.
I have recently emailed MR Hamoda head of the BMS regards more than twice a week vagifem from when I posted earlier in the year, he said there is a consensus statement on the BMS webpage regarding local oestrogen & safety 6 pages, I haven't read it as his email was enough for me he also emailed a women's health physio back with the same information, it's on my to do list.
And the agreement that it can be used up to 5 times a week & it was only reduced to twice for monetary reasons ( which we all knew anyway) .
Companies will always put clauses in regards yearly checks we are now a society of blame and sue at every given opportunity & over testing.
I recently heard Dr Currie talk re BC & HRT when ladies have been on HRT a couple of years then get BC & then blame the HRT, BC as we no starts off as a tiny cell and can take 10-15 plus years to become a detectable cancer the HRT doesn't cause it but brings it out sooner, & one can argue the cancer is caught quicker.
As with men re prostate about 80% of elderly ladies die with BC not from it & never knew they had it.
-
:thankyou: Hurdity and Maryjane.
-
:thankyou:
I've never been examined. Symptoms were enough for my GP to prescribe.
Is it yet proven that HRT brings out a cancer sooner ............. better to err on the side of caution should a tumour be found but how certain is it that HRT encourages oestrogen receptors?
Companies seem more comfortable engaging with the public too which has to be a plus.
-
Oestrogen alone if no progesterone needed takes you down to the same overall risk of getting BC as the average women ( some say less risk) it's the progesterone that seems to be the protagonist, but as always the biggest risk for all cancers not just BC is weight/ lifestyle etc. 😊 the book Oestrogen Matters by Avrum Blumin is a very good read.
-
:thankyou:
-
Thx Hurdity. I live in Canada and we have the same side effects listed as in U.S. My Dr. says Vagifem is safe to use daily for as long as needed. As with every drug, some do great and some get a ton of side effects. Personally I would rather be bald then live with the discomfort of VA.
-
Me too ;-)
-
Thanks Hurdity
Lanzalover x
-
Eeek I wasn't intending to stir up any controversy about the safety of Vagifem - but just to investigate and then report on the apparent anomaly between UK medical product info and the US commercial product website for Vagifem - in relation to hair loss, in view of recent discussions!
I saw they had put some info about safety and side effects in the letter and I presumed that was just to show that hair loss did not feature - in fact I didn't read the rest of the letter after the hair loss bit as I saw it was just abstracts from papers and knew that there was no issue about safety as well as current medical practice (to use indefinitely).
Incidentally I wasn't aware that oral oestrogen as part of HRT can cause hair loss (according to NN) - unless of course they are also referring to combined HRT paired with some testosterone derived progestogens, known to cause androgenic effects in some women? However this thread is about Vagifem, and not hair loss in general so I won't pursue that one here!
Maryjane I would be very interested to see the consensus statement - especially if it updates the 2016 BMS recommendations on HRT in terms of research etc. Even though current practice differs, these do actually state that because there is little evidence beyond one year of use, clinicians should aim to use the lowest effective dose etc. Unfortunately the full consensus statement is only available to members of BMS, but maybe Mr Hamoda e-mailed it to you? However I really didn't want to raise safety etc as an issue if it was in question - I just quickly added it to the title for reasons above - as I saw they (NN) had put info in the letter!
Apologies if this has caused anyone any concern ie the safety aspect and as always all women should report any unusual bleeding to their GP.
Hurdity x
-
No worries we likes a good meander :D
-
Hurdity I have messaged you.😊
-
Thanks Hurdity for going to the trouble for us :-*
I am prone to hair loss, and it has defo accelerated since being on oestrogel 1 pump and vaginal utro x 14 monthly, testogel and vagifem
Not having oral oestrogen, does anyone anymore? I think it's safe to rule out vagifem being the culprit, so am I to think that it's a pea-sized testogel causing it? Sorry, I know this thread isn't about me and my hair loss but I am quite alarmed with the loss on my barnet since starting hrt, and would really appreciate any enlightenment.
TD
-
Hi hurdity
I disagree with that if you read the statement in the vagifem website where it says oral estrogel side effects should be taken into account , it then has full stop and then clearly says he most commonly reported side effects of vagifem are : which then says hairless so i am taking that as maybe people using it have reported hairloss ! I also agree though that from my personal experience systemic estrogens do also cause hairloss as I know many women who have had hysterectomy take oestrogen only and have hairloss me being one of them that is 5 yrs post meno had no hairloss from low levels of hormones until initiating hrt and it's not thyroid or lack of vit as bloods all normal and this would be apparent within the 4 yrs I didn't take hrt ! People are quick to blame progesterone but I think estrogen is culprit and with women who take this alone is because of the increase in estrogen and its ratio to other hormones causing an imbalance all 3 hormones need to be replaced not just one , so I'm experimenting at the moment by using 3 pumps of gel and adding in progesterone to see if this improves my hair and other symptoms ! One question though is 3 pumps of gel to much for 100mg of progesterone ?
-
Hi There,
I know your post was a long time ago but I have recently had unexplained hair loss and it is very upsetting. I have recently been taking Livial and I think this might be the cause. I also had covid quite badly back in May and this too might have caused shedding. I am awaiting blood results and I'm taking hair supplements to help too. It started the third week in July and is thankfully slowing down a bit. Before Livial I was on Activelle and femoston conti , I didn't feel any different taking them so asked the doctor for a change. She offered Livial. My symptoms were mood swings and tiredness mainly. She also mentioned the oestrogen gel pumps and the utrogestan tablets but I think after reading all about different HRT I will just not bother taking any of it ! How did you go on with your hair loss and did you find the cause please ? Kind regards Carol.