Botox during pregnancy?

Botox risks for mother and child

Is Botox taboo during pregnancy? Can it harm the baby, cause premature birth or even lead to abortion? These are important questions that pregnant women rightly ask themselves. And for those who want to breastfeed their baby, they are still relevant after birth. I will try to answer them as best I can in the following text.

These are the topics:

Why not just let it stay?

The obvious question

One question immediately springs to mind: Why not just leave Botox when you’re pregnant? Shouldn’t that be an easy decision? But unfortunately, it is often not as trivial as it sounds. Or not anymore. Because for a long time now, Botox has not just been about wrinkles. Other medical applications have become equally important. Botox is currently used to treat a whole range of disorders. In addition to spasms and dystonia, among others, teeth grinding, heavy sweating and chronic migraine. Discontinuing Botox almost always means an exacerbation in these conditions.

Botox often important medication

While cosmetic Botox can be easily discontinued to avoid risks, many other cases are not. All the more so because Botox also alleviates disorders that often worsen in the course of pregnancy. For example, the hemimasticatory spasm. These unilateral spasms of the masseter muscle are very painful. But with Botox they become bearable. And those who are treated with Botox for such ailments, usually all other therapies have already been unsuccessful. Only then will Botox be reimbursed by the insurance companies. The question is therefore important whether or not Botox poses a risk to the mother and child.

What does science say?

Data situation: available but thin

Unfortunately, the data situation on this issue is more than thin. There are few studies that address the question. But at least they all come to the same conclusion: no complications occurred in the observed cases. Even if the mother was previously treated with Botox. Healthy children were born in all cases.

Methodological deficiencies

Unfortunately, however, these studies all have a catch: they have methodological flaws. And are therefore only of very limited informative value. The reason for this is obvious: no pregnant woman will expose herself or her child to risk just to participate in a study. The little data that is available therefore comes primarily from women who were already participants in a Botox study and then unexpectedly became pregnant in the course of it. They dropped out of the study but continued to be followed until birth and into lactation. Data on Botox in pregnant women usually come from such individual cases. There is no question of “controlled studies”. And that definitely calls for caution. Particularly since animal studies did provide evidence that there are risks to the fetus. Manufacturer Allergan summarizes these trials in the following note thus:

In reproduction studies in mice, rats and rabbits, embryotoxicity (delayed bone formation and lower fetal body weight) was seen at high doses.

(Allergan, Fachinformation VISTABEL, Stand: 09/2018)

Many open questions

Research at odds

Research also disagrees on a number of issues. For example, it remains to be seen whether Botox injected into a muscle in the face can migrate to other parts of the body. And then possibly ends up in the placenta at some point or in the mammary glands – and thus perhaps in the mother’s milk. Or whether the molecules of the toxin are not too large to pass the placental barrier.

The manufacturers are cautious

Even Botox manufacturer Allergan has to pass on such questions. The package insert for VISTABEL (brand name for cosmetic Botox) simply states:

Pregnancy: There are insufficient data on the use of botulinum toxin type A during pregnancy. Studies in animals have demonstrated reproductive toxicity. The potential risk to humans is not known. It is recommended not to use VISTABEL during pregnancy and in women of childbearing age who are not using contraception.

Lactation: It is not known whether VISTABEL passes into breast milk. The use of VISTABEL during breastfeeding cannot be recommended.

Those who depend on Botox as a therapy because their well-being would otherwise be severely impaired are hardly helped by it. But neither does his doctor, who wants to assist with medical advice. On this basis, patients can therefore only be advised to exercise caution. And when in doubt, that means no Botox.

What do the professional associations say?

The professional associations advise against

And that’s exactly how recommendations from experts read. They formulate official positions that physicians can refer to in their consultations. And thus facilitate the discussion. Despite warnings in the package insert, VISTABEL (as well as all other Botox preparations) is officially approved for use during pregnancy and breastfeeding. Neither is listed as a contraindication. Which leaves the decision up to the doctor. But how should he decide? On the one hand, the pregnant patient who suffers when she has to stop Botox. On the other hand, the data neither proves nor invalidates that Botox harms the baby. What is right, what is wrong?

The German Dermatological Society is very clear in its guideline: it describes pregnancy and breastfeeding as an “absolute contraindication”. And thus goes beyond the official approval. However, not without the hint:

however, there is evidence in the literature that BTX-A does not cause malformations during pregnancy. In addition, one patient due to dystonia cervicalis was treated with 600 U to 1200 U of onabotulinumtoxin A in each of 4 pregnancies without adverse fetal outcome.

The German Society for Aesthetic Botulinum Therapy (DGBT) expresses itself somewhat less explicitly, but then also comes to a clear recommendation:

A general recommendation regarding the use of botulinum during pregnancy cannot be given. The German Society for Aesthetic Botulinum Toxin Therapy advises against treatment during pregnancy and breastfeeding for safety reasons.

My own opinion

I myself concur with the advice of the professional societies. As a pregnant woman, you should avoid Botox whenever possible. This also applies during the breastfeeding period. Anyway, Botox for cosmetic purposes. When treating real disorders, you have to weigh things up: Is Botox therapy really mandatory or are there alternatives? Is it about avoiding severe, painful cramps or sweaty soles? Considering all the advantages and disadvantages, one may then come to the decision with the doctor to continue the treatment with Botox despite pregnancy.

And what about hyaluron?

My opinion: taboo from SSW1

The question of Botox in pregnant women is often asked, that of hyaluron much less frequently. However, the problem is similar with hyaluron. And there is virtually no reliable data from pregnant women on this either. After all: hyaluron is a natural component of the body. And it is also not toxic. With Botox, as we know, it’s different. Therefore, one might think that hyaluron is not risky.

But this is not the case. On the one hand, because of the injection itself. After all, it always carries a certain risk of infection and allergic reactions. On the other hand, because of the enzyme hylase, which can indirectly become a problem. Namely, when injected hyaluron has to be dissolved again because of problems. Such a problem could be, for example, an allergic reaction or even necrosis. For this, it is necessary to inject hylase, which is able to dissolve hyaluron. Hylase, however, is contraindicated in pregnant women. Also for breastfeeding women. So in an emergency, you would be left without an antidote. Or faced with the choice of putting his baby at risk for hylase. And one would like to avoid such a case as much as possible. Therefore, I also strongly advise pregnant and breastfeeding women against hyaluron.

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