Herbal Estetrol: How Safe is the New Mini Pill?

Anyone who takes the birth control pill usually wants to use it as a contraceptive. It should be accordingly safe. But the preparation should also have as few side effects as possible – and unfortunately that is such a thing with hormonal contraceptives. Now comes A new minipill will be on the market from July: The drug Drovelis uses the estrogen Estetrol for the first time in combination with the already used progestin drospirenone. Estetrol is made on a plant basis. That sounds good at first. But is that also harmless?

New pill with Estetrol: is plant-based always healthier?

At the press conference for the presentation of the new preparation, Dr. Ludwig Baumgartner, specialist in gynecology and obstetrics: “Estetrol is a physiologically occurring estrogen, but its biological function has not yet been conclusively clarified.” However, it is known that the hormone is produced by the fetal liver from the ninth week of pregnancy. It then enters the mother’s circulation via the placenta.

In the case of the plant-based Estetrol for the pill, the developers speak of “bioidentical”. The second component of the combination pill is the progestin drospirenone. This in turn is responsible for preventing ovulation. The Estetrol stabilizes the menstrual cycle. This is supposed to prevent unwanted bleeding, for example.

That this component of the pill also occurs naturally sounds good at first, doesn’t it? There is only one catch: So far, and this is what Baumgartner’s statement suggests, it is not entirely known whether this naturally occurring estrogen Estetrol is also less harmful than one of the artificially produced estrogens that are otherwise used for pills. Especially with regard to thrombosis, one of the possible side effects of hormonal contraceptives, this is not clear. The preparation was approved anyway.

The risk of thrombosis with the new pill is unknown

Combination pills increase the risk of developing a thrombosis. This is due to the hormones used. In other words: Anyone who already has an increased risk of developing blood clots through smoking, high blood pressure, overweight or family reasons or simply the age – over 35 – would do well to consider using hormonal contraceptives. This applies if more than two of the risks mentioned apply.

Or at least rethink the type of pill. Because preparations that have been known for a long time, the 2nd generation pills, increase the risk of thrombosis less than the newer 3rd or 4th generation pills. One to two percent of thromboses that occur after taking pills are fatal. That is not much when extrapolated to everyone who takes such drugs, but the risk exists and is higher than if no pill is used.

There have of course been studies on the risk of thrombosis with the new pill with Estetrol. There was one case of deep vein thrombosis and one case of superficial vein thrombosis (thrombophlebitis) among 1533 participants (1218 had completed the study) in one study and 1864 (or 1016) participants in another study, summarizes the “Spiegel” together.

The problem: In the study, the preparation was not compared with another, already available with a different composition. For preparations with drospirenone, which contain the estrogen ethinylestradiol instead of estetrol, there are around 9 to 12 cases of thrombosis per 10,000 users per year. But that cannot be transferred to the combination with Estetrol, says Baumgartner.

What actually happens when you forget the pill and how should a woman act? You can see that in the video:

Comparative study is requested – reference date in a few years

So far, based on a phase II study, there has only been evidence of a slight influence on blood coagulation in women with an average age of 26 years. But the data are not yet conclusive and further investigations are necessary.

For safety reasons, women with an increased risk of thrombosis should initially only be prescribed the new preparation carefully, the “Pharmazeutische Zeitung” quotes the gynecologist Dr. Katrin Schaudig: “At the moment I am still warning against prescribing the preparation for patients at risk of thrombosis. We have to wait for endpoint data.”

But it can sometimes take a few years before they come. The drug was also recently approved in the United States. The responsible authority FDA is now demanding a study on the safety of the active ingredient combination from the manufacturer. Cut-off time: June 2027.

The pill is not suitable for every woman. But other contraceptives are not always convincing either. Problematic: To this day, contraception is mostly a woman’s business. Test of contraceptives: not even half of the pills are recommended. Some gynecologists are therefore certain: “These days the pill would no longer be approved at all”. For these reasons, by the way, the pill for men still does not exist. The side effects are too great. For comparison: They correspond to those that are printed on the package inserts for birth control pills for women.

These Drovelis side effects are well known

The new minipill was tested for common, more common side effects. The most common are the same as classic pill side effects and are:

  • a headache
  • Acne
  • Dysmennorrhea (cramp-like, long-lasting painful conditions)
  • vaginal bleeding
  • Metrorrhagia (acyclic bleeding from the uterus)
  • Mood and libido disorders
  • Abdominal pain and nausea
  • Chest pain
  • Fluctuations in weight

The pill is taken without a break: 24 pink tablets contain active ingredient (15 mg estetrol and 3 mg drospirenone), four white tablets contain no active ingredient, only lactose.

Shouldn’t new preparations be tested for known side effects?

One thing is clear: with many drugs, very rare side effects are only discovered after the drug has already been taken many times. This is also similar with vaccines, as you can see from the current emergency approvals for corona vaccines. There is only one big difference, emphasizes the “Spiegel”: Thromboses are known to be a not so rare side effect of hormonal contraceptives.

It should actually be a matter of course to first test new preparations with a similar composition for these known side effects before they can be prescribed. Especially if it is not an emergency situation like the vaccines during a pandemic, but a drug of which numerous other variations exist and for which there are also alternatives. Even alternatives without hormones. For example, these are copper spiral and copper chain. Interesting to know: Fewer and fewer women are taking the pill.

Especially when it is so strongly advertised that it is a product with a plant-based and therefore “natural” component, one would like to evoke a certain feeling of security in the user. The manufacturer is certain, however, that it would be a “miracle” if the risk of thrombosis with the new pill were not lower than with comparable drugs. You ask yourself: Why didn’t you check that before approval by means of a direct comparison? As I said: After all, there is no urgent need for a new preparation for contraception. What is there is the need for safe means of contraception that are as free from side effects as possible, and a healthy education about possible problems that contraceptives pose, especially for women.

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