Menstrual issues
A recent strong increase in heavy menstrual bleeding, was mentioned in the British Medical Journal (BMJ). It is unclear if EMA has looked into this based on their data, what happens when we do it?
select
reaction,
count(distinct local_number)
from import.product_reaction
where reaction ilike '%menstru%'
group by reaction
order by count(distinct local_number) desc limit 10;
We can see that related to products, there are 1920
reports mentioning Heavy menstrual bleeding as (one of the) reaction(s).
reaction | count |
---|---|
Heavy menstrual bleeding | 1920 |
Intermenstrual bleeding | 1100 |
Menstrual disorder | 1043 |
Menstruation irregular | 957 |
Menstruation delayed | 819 |
Premenstrual syndrome | 91 |
Premenstrual pain | 18 |
Menstrual discomfort | 17 |
Menstruation normal | 10 |
Menstrual cycle management | 6 |
select
reaction,
count(distinct local_number)
from import.substance_reaction
where reaction ilike '%menstru%'
group by reaction
order by count(distinct local_number) desc limit 10;
reaction | count |
---|---|
Heavy menstrual bleeding | 48794 |
Menstrual disorder | 30349 |
Intermenstrual bleeding | 26426 |
Menstruation irregular | 25405 |
Menstruation delayed | 18877 |
Premenstrual syndrome | 2325 |
Menstrual discomfort | 1336 |
Premenstrual pain | 921 |
Menstrual cycle management | 300 |
Menstruation normal | 294 |
For substances it is 48794
reports.
We want to see if any substances stick out.
select a.name, b.* from
(select
--reaction,
substance_id,
count(distinct local_number) count
from import.substance_reaction
where reaction = 'Heavy menstrual bleeding'
group by substance_id, reaction) b
JOIN import.substances a on a.substance_id = b.substance_id
order by b.count desc limit 10;
name | substance_id | count |
---|---|---|
COVID-19 MRNA VACCINE PFIZER-BIONTECH (TOZINAMERAN) | 42325700 | 25570 |
COVID-19 MRNA VACCINE MODERNA (ELASOMERAN) | 40983312 | 7791 |
COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) | 40995439 | 5062 |
LEVONORGESTREL | 19980 | 3405 |
ETONOGESTREL | 18832 | 1634 |
DESOGESTREL | 18500 | 383 |
ETHINYLESTRADIOL, ETONOGESTREL | 39209 | 347 |
LACTOSE | 25479 | 288 |
DROSPIRENONE, ETHINYLESTRADIOL | 59494 | 242 |
COVID-19 MRNA VACCINE PFIZER-BIONTECH ORIGINAL/OMICRON BA.1 (TOZINAMERAN, RILTOZINAMERAN) | 60123556 | 212 |
It seems that, given that "Heavy menstrual bleeding" totals 48794
reports for the substance table and 38423
reports from that same table are related to COVID-19 vaccines, we feel that this should be something of concern. This appears to be something that justifies further research, also by EMA.