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?
  • What does science say?
  • Too many open questions
  • What do the trade associations say?
  • My own opinion
  • And what about hyaluron?

Why not just leave it?

The obvious question

One question immediately suggests itself: Why not just let Botox go when you’re pregnant? Shouldn’t that be an easy decision? But unfortunately, it’s 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 just as important. Botox is currently used to treat a whole range of disorders. In addition to spasms and dystonia, these include teeth grinding, heavy sweating and chronic migraines. Discontinuing Botox almost always means an aggravation of 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 during pregnancy. For example, hemimastic 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 conditions have usually already had no success with all other therapies. Only then is Botox reimbursed by the health insurance companies. It is therefore important to ask whether Botox poses a risk to mother and child or not.

What does science say?

Data situation: available but thin

Unfortunately, the data situation is more than thin on this issue. There are only a few studies that deal with 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 the study. They dropped out of the study but continued to be followed until birth and into the breastfeeding period. As a rule, the data on Botox in pregnant women come from such individual cases. There is no question of “controlled studies”. And that in any case calls for caution. Particularly since animal studies did indeed provide indications that there are risks for the fetus. The manufacturer Allergan summarizes these tests in the following note:

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

(Allergan, VISTABEL SmPC, as of 09/2018).

Many open questions

Research at odds

Researchers also disagree on a number of issues. For example, it is still unclear whether Botox, which is injected into a muscle in the face, can migrate to other parts of the body. And then it might eventually end up in the placenta or in the mammary glands – and thus perhaps in the mother’s milk. Or whether the molecules of the toxin are too large to pass through the placental barrier.

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 that VISTABEL not be used during pregnancy and in women of childbearing potential 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 rely on Botox as a therapy because their well-being would otherwise be severely compromised are unlikely to be helped. 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 in case of doubt, this means: no Botox.

What do the professional associations say?

The professional associations advise against

And this is exactly how recommendations from professional circles read. They formulate official positions that physicians can refer to in their consultations. And thus facilitate the discussion. Because despite warnings in the package insert: VISTABEL (as well as all other Botox preparations) is officially approved for use during pregnancy and lactation. Both are not mentioned as contraindications. So the decision is up to the doctor. But how should he decide? On the one hand, the pregnant patient who suffers if she has to stop Botox. On the other hand, the data, which neither proves nor invalidates that Botox harms the baby. What is right, what is wrong?

The German Dermatological Society expresses itself very clearly in its guideline: It calls pregnancy and lactation 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 was treated for dystonia cervicalis in 4 pregnancies with 600 U to 1200 U onabotulinumtoxin A without negative consequences for the fetus.

The German Society for Aesthetic Botulinum Therapy e.V. (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 is also true when you are breastfeeding. Anyway, Botox for cosmetic purposes. When treating real disorders, you have to weigh up: Is Botox therapy really mandatory or are there alternatives? Is it a matter of avoiding severe, painful cramps or sweaty soles? Considering all 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 about Botox in pregnant women is often asked, the question about Hyaluron much less often. The problem with hyaluron is similar. And there is almost no reliable data from pregnant women about it either. After all: Hyaluron is a natural component of the body. And it is not toxic. With Botox, as is well known, this is different. Therefore, one could believe that hyaluron is not risky.

However, this is not the case. On the one hand, because of the injection itself. 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 an allergic reaction or necrosis. For this, it is necessary to inject hylase, which is able to dissolve hyaluron. Hylase, however, is contraindicated in pregnant women. Also in breastfeeding women. So in an emergency, you would be left without an antidote. Or you would have to choose between exposing your baby to the risk of Hylase. And one would like to avoid such a case as far as possible. I therefore strongly advise pregnant women and nursing mothers not to use hyaluron.