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If looking at the package insert stirs up fears
Patients and doctors are then faced with the challenge of making individually sensible decisions and weighing up the benefits and risks. And that’s not always easy, because the data is often sparse.
Wolfgang Paulus knows: For medical laypeople – and that is most pregnant women – the topic of medication can be overwhelming. He is head of the advice center for medication during pregnancy and breastfeeding at the Ulm University Hospital. Together with his team, he advises up to 4,000 patients and doctors every year.
He says: “The information on package inserts often causes so much anxiety and concern that you either don’t take anything at all, which can become a problem with some underlying illnesses.” Or women accidentally take medication and later panic when reading the package insert.
Why data on pregnant women is missing
There are reasons for the drug manufacturers’ reluctance. For example, the Contergan scandal in the early 1960s, in which taking a sleeping pill during pregnancy led to thousands of children being born worldwide with severe malformations. Since then, pregnant women have been largely excluded from studies on drug approvals, says Wolfgang Paulus.
Animal experiments also do not provide reliable data. On the one hand, the metabolism of animals is different than that of humans. On the other hand, multiple doses of the active ingredients are often used in such experiments. “This occasionally leads to complications that do not occur in humans,” says the doctor.
How do you even come to scientific knowledge? “The only strange option left to us is to wait until someone, unplanned and unaware of the early pregnancy, has taken medication that should not have been taken according to the package insert,” says Wolfgang Paulus.
Such cases would be recorded and further monitored. Only when a sufficient number of cases have been recorded can warnings be partially put into perspective. “But that often takes many years,” says Wolfgang Paulus.
It’s a constant balancing act
If pregnant women have health problems, they must be carefully considered. Can the symptoms be tolerated without medication and are they acceptable during pregnancy? Or do you have to take action, “if possible with tried and tested active ingredients,” as Wolfgang Paulus says?
The decision must always be tailored to the individual situation. Midwife Manuela Rauer-Sell knows that women’s needs are sometimes very different. “It also depends a lot on how the person is basically wired when it comes to taking medication,” says Rauer-Sell. In addition to her work as a consulting midwife for the German Midwives Association, she also works as a freelancer in the profession.
During her consultation, she examines the question of what symptoms are present and how much they affect the pregnant woman. “You don’t always have to be super brave and endure everything,” says Manuela Rauer-Sell. “Pain, for example, can also cause problems and cause stress for the mother and the unborn child.”
She believes it is important to provide precise information about this and thus give pregnant women more freedom to judge for themselves when they should take medication and when they should not.
Advisory services provide guidance
Of course, a distinction must be made: Is this a medication for a pre-existing condition that existed before the pregnancy? Or is relief needed for acute symptoms, such as pain or a cold?
If you have underlying illnesses and associated medication, pregnant women should definitely seek advice from the relevant specialist and, if necessary, other information services. “I have often experienced that women are well advised when they get a second opinion. Based on solid information, the acceptance of medication increases,” says Manuela Rauer-Sell.
In addition to the Ulm University Hospital, the Charité in Berlin also offers information on the topic. Pregnant women can receive individual advice via questionnaire or telephone. General information and risk assessments for individual medications and active ingredients can be accessed via the online platform www.embryotox.de.
Maybe a home remedy will do the trick
For mild, acute illnesses such as colds, headaches or back pain, midwife Manuela Rauer-Sell recommends trying home remedies first. From sage tea with honey to throat rinses to hot water bottles: many tricks that grandma already knew are still valid today. “I am always amazed that this old knowledge is no longer present today or that it is no longer trusted,” says Rauer-Sell.
In the case of planned interventions, such as dental treatment, it may make sense to clarify with the respective doctor whether these can be postponed until after the pregnancy.
As little as possible, as much as necessary
Can’t do it without medication? Then, according to Wolfgang Paulus, the principle applies: doses that are as moderate as possible with the duration of use being as limited as possible. The phase of pregnancy is also relevant. The first trimester of pregnancy is considered the most sensitive and malformations can occur here. “Then the unborn child’s sensitivity is significantly reduced.”
For minor complaints such as allergy diseases, the expert recommends treating the symptoms locally – if that is possible. One option is nasal sprays, which only act on the nasal mucous membranes but usually do not cause any distress to children.
In pain therapy, the active ingredient paracetamol was recently suspected of triggering asthmatic symptoms in children. It is now clear: it was not the active ingredient that caused the symptoms, but rather the stress of the pain-stricken mothers. The drug is now acceptable again with moderate use, says Paulus.
Sure, I’d be happy to help you with that! Here’s an interview with two guests about the article “If Looking at the Package Insert Stirs up Fears”:
Guest 1: Wolfgang Paulus, Head of the Advice Center for Medication during Pregnancy and Breastfeeding at the Ulm University Hospital
Guest 2: Manuela Rauer-Sell, Midwife with extensive experience working with pregnant women
Interviewer: Can you please introduce yourselves and briefly explain your roles/expertise in the field of medication during pregnancy?
Guest 1: Wolfgang Paulus: I am Wolfgang Paulus, the head of the Advice Center for Medication during Pregnancy and Breastfeeding at the Ulm University Hospital. We advise up to 4,000 patients and doctors every year on the safe use of medication during pregnancy. Our main focus is to help patients understand the potential risks and benefits associated with various medications, as well as providing guidance on alternatives when available.
Guest 2: My name is Manuela Rauer-Sell, and I’m a midwife with over 20 years of experience working with pregnant women. I’m also a freelance consultant midwife and have worked in different hospitals in Berlin. My goal is to provide individualized care and support to women throughout their pregnancy journey, including discussing the use of medication when necessary.
Interviewer: The article highlights the challenge of making informed decisions about medication during pregnancy due to limited data. How can patients and doctors navigate this dilemma?
Guest 1: Wolfgang Paulus: Patients and doctors often feel anxious and uncertain when reading package inserts, but it’s essential to weigh the benefits and risks of each medication individually. It’s crucial to consider the underlying health condition and the severity of the symptoms. In some cases, not taking medication can lead to more severe complications for both mother and child, while in others, the potential risks may outweigh the benefits. Communication and consultation with a healthcare professional experienced in this area are vital.
Guest 2: Manuela Rauer-Sell: I completely agree. It’s not
