Chapters Transcript Video Principles of Teratology: From the Historical Perspective to the Modern Era My name is Sarah Burton and I am a maternal fetal medicine specialists with subspecialty in tear it ology and reproductive toxicology that I've done um in my lifetime. And I really enjoyed that type of work. I talk on this topic so much, but I sometimes get bored and want to do a little bit of a different perspective and wanted to talk about something to do with history and how we viewed things like this in the past and how far we have gotten so far. So again, thank you for joining us. I don't have any financial relationships that are relevant to discuss and today's objectives. We're going to define the study of birth defects and explained the historical perspective of discovering those two religions and illustrate some of the basic principles of territory ology as a field of study and how we study birth defects. And then I really one of the things I hate is when we have talks that are really important that we don't give some guidance and some information. Something that you can take away for your practice, something to help you in your daily life. So we're going to summarize some tangible resources for you and your patients. So what is the strategy in the word to religion comes from the greek word Toronto's and it's really actually said because it means monster and it has nothing to do with my core values. I actually hate the fact that it's named this. But a hirogen is something in any medication or chemical infectious disease, environmental agent exposure of some kind that can interfere with normal human, an atomic development and result in something of a birth defect. And this is a type of definition we have had for decades and newer in the literature and what we're interested in is also some of these potential poor pregnancy outcome, things that can really hurt a pregnancy in other ways, like having a spontaneous abortion or having pregnancy that is struggling with growth restriction, um causing malignancy later on in life. These are all kind of impacts on these fetuses and future Children and future adults that are really important to talk about. So, the historical perspective is so fascinating to me and how we interact with our health and how we feel about our health and death and dying and birth defects, and all the things that on a health level can happen to us as human beings, has a lot to do with our psychosocial construct, and that has a lot to do with our religion or maybe our background that we have grown up with in our context of how we see the world, and this is an anglo Saxon depiction of actually health and being, and it can be very morbid and very interesting staying. But another angle Saxon depiction is actually something called the change length and you might have heard about this and it's very pertinent to babies who are not thriving well. And those who have birth defect is that when Children are born and they're not thriving, their growth restricted or they have birth defects, they don't look like you would expect a normal child to look like for, say, there's this thought and especially in the middle ages in Britain, that there is an aspect of a changeling that your child who is healthy and beautiful and was just divine is actually now gone with the fairies and living a different life. And in instead you have a changing a child that is not doing well because it was not going to survive. And this is the way to deal with that emotional onslaught and understanding of medicine where we were losing so many moms and losing so many babies and having such difficulties there that it was one way to deal with these emotional aspects of it. So your child being in the fairy land and being exchanged for the changing. There's a lot of depictions of that in art um and in history and it's still actually prevailing um in some parts of the world today. In fact these are the fairy changelings of only about 100 years ago. Um These are irish fairy changelings that what they are Children that were bored born into families with psycho social strife. And perhaps Children who had difficulties that now we would say maybe A. D. D. Or A. D. H. D. Or developmental delay of some kind and were not taken into society and they were sent to live on their own um in homes. Um and we're not part of society and it's just a different aspect of the very change length and in fact the very, very changelings were always thought to have been mostly male so that males are more coveted in this very world. And therefore there's a large tradition. And if you know this and some of the religious aspects is to actually dress even boy babies into female clothing, especially during the time of baptism in order to ward off evil spirits and have your baby actually stay with you and in the world life. So as we move on through the middle ages, how people with birth defects were dealt with changes a little bit. Actually, people were shunned for a very, very long time because nobody understood why somebody looked different than others. And it really wasn't until maybe the timeframe of Elizabeth the first Rain who was very interested in being entertained, in fact, and some of the entertainment she would be given would be presented with patients, patients people who looked different. And so this is actually Lazarus and Johannes colorado who was born is 16, 17 and by all accounts, this was a rather handsome looking man, uh, not my type per se, but he was handsome for the time and except he had a brother that was attached to his body. This was a pair of conjoined twins. Again, born in genoa Italy and throughout the lifetime, in order to be able to survive and to be able to feed themselves essentially. They went across europe and presented themselves to different courts and they made it to the Charles, the first courts in England to show off their body and how they're living. Um, and this is how they supported their, their sustenance. So this change in the 1600s 1700 where people were more interested in viewing people like this and we're just entertained by it unfortunately. And this is how the shows in the US also began of being presented with different people who again look different than what we would quote unquote called the norm. Um And you have people who look different with their hands and they have a touched again conjoined twins. Um Or really really small people that were again being showed off in there uh on the shows. And it really isn't formalized until if you know the story of P. T. Barnum and the 18 hundreds P. T. Barnum was a very famous entertainment manager and was one of the first people who really formalized how we see this. He was like a circus manager essentially. And if you've seen the movie it's a great movie, has a wonderful um soundtrack, but the actual reality is a little bit more sinister. He ended up using people like this for financial gain and, and basically had freak shit Goes to show off people who look different and that, that by that way make some money now, it might have been mutually helpful to for some of the folks who worked with him. But it was something that caught attention to a lot of ethicists at the time. In 1861 There was an ethicist who wrote about this like, what are we doing? How are we, why are we portraying people like this on stage? This doesn't seem appropriate. In the early 1900s, saw a rise in the disabilities rights and disability acts that are coming forth after that. But there are some advances in medicine to that have started making people think, well, this is not just magical. I mean, there's a diagnosis perhaps, you know, it's not necessarily unique and miraculous. And the other aspect is that they fell out of favor of it because people didn't want to quote unquote, catch whatever these people had. So they went through an incredible a turn of events through the, through that century of how we viewed people with deformities. In addition, pregnancy was you viewed an interesting way and in a way that I think there is still a little bit of a misinterpretation in the early 19 hundreds, there was a thought that the placenta is that incredible barrier between mom and child and no matter what the mom was exposed to or had done, um would not affect that future child, that fetus. And of course that's actually not true. We now understand that placenta is actually an incredible organ and it can protect the child in some ways. Put a lot of, a lot of environmental factors in a lot of medications do cross the placenta. In fact, some notable examples are things like insulin and so you can treat a mom or for diabetes with insulin and it won't affect negatively that growing fetus and same thing for things like Lovenox, it doesn't pass the placenta because the actual molecule is so darn big. But the vast majority of medications and exposures can cross the placenta and in some case can cross the placenta easily. So there was this thought, as you some may remember or no parents or grandparents that would remember this, that patients were smoking too, and people wouldn't think anything of that in pregnancy or drinking, for example, or being exposed to environmental toxicants in the Industrial Revolution and being workers in that industry. The 20th century brings new information, especially in respect to infectious disease and how it can impact our pregnancies. So in 1920 to brag actually discover that radiation of a pregnant rats can actually cause developmental eye defects. 1930s, hail looked at vitamin a deficiency and that it can cause abnormalities also in eyes and pigs. And in 1941, 1 of the big biggest discoveries is Norman Gregg, who is actually an Australian ophthalmologist who discovered the fact that rubella is actually telegenic, that rubella as a virus can cause a problem to the growing fetus. And what happened is that a certain year, 1941, there were 13 of his patients who had bilateral cataracts. It's not the bilateral cataracts doesn't happen in DNA. It's that it happened so much that particular years. So he reached out his colleagues in Australia and they found an additional 30 something cases and this slowly ended up being reported more and more. And then it was established after now many years that certainly rubella can affect pregnancies in a negative way, causing heart defects, brain defects or defects, threw him aside a pina and abnormal growth. And this is an example of an astute clinician model. And what I mean by that is that we're always so interested and rightly so and randomized controlled trials um and really having the best evidence based medicine. But unfortunately the vast majority of the literature is really observational studies, case control studies, case series and that's how this started. But somebody said, I can't believe I have 13 patients this year with bilateral cataracts. Then this is how this came to light. And Zika is an interesting aspect. I remember when this was first coming out right when we were first realizing what Zika was. Of course Zika has been around for a long time, but most of us haven't even heard of zika prior to our biggest big outbreaks now a few years ago and I remember being pregnant and sitting on the couch and we had a a really big conference call with international conference call on charity ology meeting and we're talking about all the things that are happening. And one of our colleagues from brazil said you know I have a lot of patients with microcephaly and we have a Zika outbreak and I think a lot of us are worried that this is this is going to be a thing, this is going to be a connection. And you be surprised how many very very, very smart people on that call said why would a virus do that? That seems so bizarre. And as if we had forgotten that things like rubella can cause birth defects and that power virus can have an effect on our growing fetus and that certainly ended up being the case. And Zika is a really interesting strategy in because he obviously doesn't cause as much harm to the mom as it can cause to the growing fetus. In fact, some most patients are asymptomatic and if you do have symptoms they can be rather mild and you may not ever get tested or know about it and you're only result is and having a fetus with abnormalities. And so congenital zika syndrome obviously causes severe microcephaly, a retinal damage and cortical evolution so that the cortex is becoming so much smaller and by Justin diluting that way it causes microcephaly. That's how it starts from the inside out. And this is what we end up understanding for microcephaly in association with Zika. And in fact, it's the association is so strong. And after the paper by Sonja Rasmussen out of University of florida, it's established that zika is in fact to religion. So there's no good information without some background information. And we talk a lot about this with all our patients that have questions about their exposures. Is that all pregnancies, no matter how healthy the mom, no matter what the exposure or how young, none of that matters is the fact that we're going to have a 3 to 5% chance of having a baby born with a birth defect. If you look at major birth defects is closer on the range of 3% and then smaller birth defects. Things that maybe you wouldn't really notice at the time of birth will be closer to 56% out of all of those. The most common are heart defects. And this is why I love hearts and do a lot of people like a cardiogram fee because I I love the development of the heart. It is really difficult to actually make in a fetus, which is why we end up having more defects um in that realm. Mhm. And the thought was for a long time. And maybe 5-10% of all birth defects are due to human strategies. And the reality is that my entire life's work is actually based on 1%, That's because exposures human exposures are not the biggest contributor to an atomic disease to an atomic abnormalities. And we'll talk a little bit about what that potential is, But it certainly causes a tremendous amount of strife and accounts for about 20% or more perinatal deaths. The issue with exposures is that you you wouldn't believe this, but I look up this data every once in a while, because it's always shocking to me that 50 to 90% of us women use medications during their pregnancy and some of our patients are getting older and that might be completely warranted because they have chronic hypertension. And there are medications that may take Tylenol, Let me have to take aspirin for some indication or another. The issue is that the exposure is really great, but the perception is that the medication that they're using may increase their risk of birth defects. So, so much so, even though they're true, risk is really small, overall 1%, Um, but in vast majority of cases, very little to none. The estimate of their risk in their mind, or sometimes even in the provider's mind that it might be closer to 25%, and that's in some of the literature. So this is that pie of the causes of birth defects. The vast majority of our human babies are quote unquote normal. So without an atomic defects is what I mean by that, and 3%, let's say, have birth defects. What has changed over the course of the years and most notably within this last decade, is really where is that pie coming from? What are the ideologies of these birth defects? So we would say maybe single gene defects caused this. But in reality, the single gene defects are now contributing much more to an atomic disease. Uh, that unknown area, that yellow area that actually is much smaller because genetics is taking a big portion of that. What stable is that medication is still about 1-2% medication exposure, but things like maybe preconception disease, maybe diabetes is a greater contributor. Obesity is a greater contributor, alcohol use and abuse. Maybe a greater contributor to an atomic issues. So the greatest thing I guess in in a tear Italia gist in terms of our history is really like the thalidomide embryo apathy there. If you think about human history there is the A. D. NBC right before christ after christ. I mean right now with technology, the thalidomide embryo apathy is really the sentinel event That has caused this to be a field of study. So this incredible catastrophe that happened because in the end of 1950s and early 1960s this medication was utilized for a multitude of things. It was a sedative, it was an anti medic. A lot of patients were on and across the world, not in the U. S. Because of FDA regulations. Um and because somebody was very smart and thought about what this could cause problems in animals. Maybe it's not appropriate for humans in any case. This particular event is what changed FDA rulings. What changed how we do animal studies, how we do studies in humans and test things before they get to the market. It was quite the event that had manipulated a lot of how we take care of patients and medications that are approved. Yeah but the little might embryo apathy or or fuck amelia or limb defects. They're not new. The fact that we have pictures like this and and historically we know of people who had deformities like this. The issue is that with thalidomide um after the use of thalidomide that the numbers were so much higher, rare defect super rare defects became a little bit more common. And so so little my toxicity is actually very has little toxicity. And adults And this is actually the problem when you have a mom that's exposed to something and they don't like the smell or they don't like the medication or they don't feel good when they take the medication, they're not gonna take it to the point where it may affect their uh, affect their growing fetus. But when you don't have, when you have actually some benefit of the exposure, you don't know that it actually may affect your fetus. So all this was starting to come out at the end of 1950s, early 1960s and McBride and lens independently made the association between these malformations and a lot of mine. And now we know that the little my does cause limb reduction defects, facial hemangioma to a soft gel. Atresia cardiac active. That cranial nerve defects very common. And we actually also know the very sensitive time period essentially to the day. So if somebody has exposure to thalidomide, which by the way, still happens because it is utilized for multiple myeloma. And it's still FDA approved for that indication. Um if it's utilized during certain parts of that first trimester, i if this baby is going to have a defect, we have actually some certainty as to what kind of defect we're going to have. We have a lot of information about that. About 20% of all those who are exposed to fill it in mind will have a birth defect. So not all. So here's some of those tenants or principles of territory ology. What really makes tear it ology, what it is, there's so many aspects of it. Developmental timing is important. In other words, when in the development, was the patient exposed the dosage effect? How much um is that patient exposed to genetic susceptibility? That's actually a really important aspect. We won't spend a lot of time on that here because that would be a separate genetics lecture. But it is a really growing body of evidence. The fact that turret agents cause a pattern of malformation. So not every single origin causes every single malformation. There are, there's a pattern to them and people can tell which things are more associated with what and then the idea of tissue access and how some medication maybe prescribed differently and how they may have a different effect on the fetus. So we'll start with timing the timing of events. And this is the very beginning of human embryology and timing of development. And unfortunately in the US, as you probably may know, is how difficult it is to get. Sometimes patients during the appropriate time, right. When people come, patients come to see me for for their visits, they end up seeing me. Maybe it's six or eight weeks of gestation. And quite honestly, this is the time frame where the vast majority of the anatomy has already formed. I can't necessarily have an impact on that human development unless I see the patient prior to pregnancy and really early in pregnancy. This becomes really important with, like acid intake becomes really important with pre pregnancy disease. So with gestational diabetes, for example, and getting them under control. We also understand the period of greatest sensitivity in some strategies. So these are some of the papers we've written on methotrexate. So methotrexate is obviously not utilizing pregnancy, but and maybe your lives for pregnancy of unknown location. If we have an ectopic pregnancy, we want to give methotrexate because we don't want that pregnancy to continue because it can hurt them on. Um, So the idea of maybe being exposed to methotrexate and what it's a mistake and it was actually an intra uterine pregnancy. What can that exposure to due to the growing fetus? And we have now more information again, not only exactly on the timing, but exactly on the pattern of malformation. We would expect to see. Warfarin has also a pattern, but also a critical time period. Warfarin has a very classic nasal hyperplasia stifled efficacy. These limb hyperplasia is very common and it's specific 6-9 weeks of conception. Um you can have some issues later on in pregnancy, but Really you're not going to have nasal hyperplasia necessarily. If the medication is given after the 6-9 weeks uh conception and a lot of this has to do with the dose, right dosage is so important. How much do you give to somebody? This is um Paracelsus who is thought to be the father of tear it Ology, he was a physician and astronomer, chemist. All those things back in the day. You have to do everything, You just couldn't be a physician, you had to be kind of a very knowledgeable person. And uh he touted him as a, as a physician and he said all substances are poisonous and there is nothing that is not. It really, really depends on the dose. So, the dosage effect is that a vast majority of really known to religion. So, icy treat, known, for example, methotrexate, um Cytotec miSOPROStol. Uh, these are medications or exposures that have a dose response relationship. So the greater the exposure during pregnancy, the more severe the peanut ipic effect. And perhaps the more patients affected in that population, and there may be a dose or a threshold below which there is actually no effect seen. This is actually some secular data, secular trend analysis that we published um in regards to the little mind. So this is looking at more community data, more different uh multiple patients in different countries. What you have is the sales of the little might go sharply up at the end of the 1950s that are then about nine months later to a year later followed virtually mirror image with the case of cases of the little mind embryo apathy. This is fascinating. This is a true true throughout urgent when we see in our community that it happens exactly how it's supposed to. And obviously this is years later when people I figured this out. But this is what secular data actually looks like. So radiation radiation is a common example of what patients want to talk about. An ultrasound. M. R. I. C. T. Exams. And a lot of this data, I believe it or not um comes from a completely different source. It doesn't come from your medical radiation if you will. Um This is uh HBO series uh for 2019. Culture Nobel, Which was the nuclear reactor disaster that occurred uh in real life in 1986. Um and I think the series is also phenomenal. It's so well done. But it is a little bit um I guess I guess it's like it's like I don't know how to say it emotionally charged. I guess if you will, the reality of the situation is that we don't have a tremendous amount of information. But this is what people think about. When I say I really want you to have a ct scan, they're like oh my goodness, radiation. And and they go back to some of these events they recall Um the truth is that after this disaster, only two people died that day, 28 people died in the coming weeks. And this is absolutely obviously horrific. But it was more of an economic crisis and and a family crisis because people were moved from cities, completely, entire cities were completely removed from there and the families were displaced. Um The truth is, we don't have a lot of information of what radiation does. And all your preconceptions about radiation and animals with multiple heads and so forth is really not necessarily founded. And in fact, some of the greatest information we have comes from the survivors of atomic bombs, Hiroshima and Nagasaki. This is where we actually get some radiation information. Um and what we can understand from those exposures is that there there can be obviously severe, obviously, death and destruction all those things. But in terms of patients who are a little bit more distant to that, And if they were exposed between eight and 15 weeks of gestation, they had an increased risk of growth restriction. Microcephaly, developmental delay. In fact, that is the time frame. The 56 weeks. There is more of an all or nothing event when it comes to radiation. Um more so than in the age of 15 weeks, which is really, really terrible. Now in terms of radiation exposure, the amount of radiation those people experience was incredibly high. It is nothing that our patients experience in the hospital or outpatient radiology setting, especially in your normal diagnostic imaging. So our body of evidence are ACOG and International Commission on Radiological Protection, about you know, there's a threshold about five rads or 10 rads, then maybe we should talk to patients about and warn patients about possible effects. And if you look into the right a lower area of the screen you'll see that abortion occurs at greater than 5000 rads. Microcephaly developmental delay at about 50 rads. But we should start counseling patient about by brad's and that's purposeful that is done. So we are as quote unquote as safe as possible so that we are within the margin of error for sure. And I think it's really important, especially in patients for example have a motor vehicle accident and they've had multiple C. T. Scans. That is absolutely a conversation to be had. But this is what our patients are in reality exposed to a chest X ray is really, really nothing. I don't think twice about a chest X ray. The abdomen is shielded during the course of a chest X ray and the exposure is very small. But point out to 2.7 million rads you have a decent amount of exposure of just being in a plane between the US and europe. For example, the higher ones, of course are like a ct abdomen. That's about 3.5 rads which bring up the idea of if you had multiple C. T. Scans during the course of pregnancy, then we should definitely have a conversation of what are some of the risks. And how do you see? T. Is is fascinating. This is definitely out of my realm of knowledge. But I do work with some wonderful people who are a radiologist or radiation oncologist who are able to actually quantify. What are the rats that my patient will be exposed to? If I have a patient with a brain tumor and we'll have radiation to the brain. What are my potential effects to that fetus? And they can be calculated and believe it is dependent on the gestational age and how far that top of the fetus, the top of the uterus is to the location of where the radiation is going to be. There is a cancer risk that is in the literature and I do something spring up with patients. I think it's important. The risk increases very small, but obviously it's very scary if people get this information elsewhere, it's important that they get it from valid sources. So for example, There might be a primary risk to the fetus in terms of cancerous like Leukemia. If the risk of baseline is one in 3000 Perhaps the risk now is one in 2000. So again, not an incredibly big, but relative big increase, but not an actual big increase. All these residents, they have, they have a pattern of malformation. They, um, tragedies like ISIS threatened. No one have a very specific look to them. These kids look at a certain way, and for example, this is a really cute baby with fetal alcohol syndrome, but this baby does have a very smooth fill trim and has a very long, um, a smoke filled room in a very thin upper lip and they have a certain look to them the same. Okay, so for alcohol, you know what, what what causes a problem? Is it five drinks a day? Is that any drink is just a sip of alcohol? The truth is, we don't know. The data isn't honestly there, and some physicians will say, well, no big deal. I mean, I guess you can have a glass of wine, but the truth is, we have no idea why and who might be more predisposed than others. Fetal alcohol syndrome does occur most commonly in those patients who are binge drinkers. But other effects that are quote unquote smaller may also be an effect from alcohol. And we just don't have that data, unfortunately. And that compulsion. Every empathy is a little bit different. This baby has a very broad, depressed upper nose. If you can see in that image, it has a very short, knows it has a very long um uh like a cupid's bow, almost look to that upper lip and the filter um is long and very, very pronounced. It may have this plastic and hypoplastic fingernails and fingers, but it also may have an increased risk of heart defects and oral clefts and limb abnormalities as well as developmental delight. But again, even though there's a lot of things on this list, there is a pattern that fits to these patients who are exposed. And then tissue access is a really interesting one. So obviously we talked about so many things cross the placenta. And the question is, well, how much does it cost to cross the placenta? And does it matter? And route of administration really does matter. So, let me give you an example of a cute, a nice trip. No. And obviously that's a pill that is ingested. And this is as a strategy. And as they come right, um 35% of all of those exposed will have a congenital defects such as cns abnormalities, ear abnormalities, cardiac defects, sinus issues. And even without those defects, 25%. Additionally, well, without malformations will have a developmental delay. Now, um this is what these kids may look like. This is also incidentally what Michael Fennell, it may look like Michael Finley is a different medication that um came came into kind of literature maybe a few years back where they have an inverted years for your abnormality is to look for with an example of a topical retinoids. So treat annoying or retin A um is completely different than a key chain. So even though there are a vitamin A derivative, if you remember from, from our past, learning about cece retinoic acid are all trans retinoic acid and how that structure molecular structure is different. They do have a completely different impact on our embryology. The addition to that is that retin A is not adjusted retin A is put on the skin. I don't say the patient. So I just use the retin a. It's not a big deal, but in reality it really isn't a big deal in terms of causing birth defects because it doesn't reach the fetus as Accutane would there one would say that essentially the polar opposite of each other. And it has to do with their the way they are molecularly. And it has to do with tissue access. And we have known that since The 1990s. And it's really hard for people to understand that for providers to to understand that. And for patients to understand that we've certainly had some um some worried patients come to us. Oh my goodness. I have been using Botox, I've been using retin a on my skin and I realized I'm now eight weeks pregnant. So how do we talk about how we talk about risk to our patients? These you might recall are the FDA categories and it's the A. B. C. D. X. Categories which was utilized to hopefully depart some sort of um either concern or worry about patient exposure to medications. So, every medication was designated a category. The issue with categories is that they don't work very well. And since the FADA had put in the categories ever since that time, they've been trying to get rid of them and it took many, many years like 19 years or more to get rid of the categories. And the reason for that is because these are the definitions of it, But the vast majority, in fact 65% of all medications are going to fall under Category C. And then Category A. Just says, well we have some studies but we don't have any, doesn't show risk, doesn't mean there isn't any risk. And then Category X says it's contraindicated in pregnancy. But the reality is that things like um things like oral contraceptives are actually a category X. And the reason there are category X is not because they cause harm to the fetus is because they don't work once you are pregnant, oral contraceptives do not work anymore. Um So that is the story about the FDA categories and the work that's been put to actually Change those has been now very vast. And the reason is because it's completely oversimplified and it seems easy at 2:00 AM and the er to say you know what, it's a category B not a big deal, don't worry about it. But it doesn't take into account timing of the exposure, the dose of the exposure, the indication of the exposure. Why is somebody taking a certain medication? Can they do without it? Um And unfortunately they're not frequently updated. So there is a designation that is given, let's say there's a designation as a category C. Um and then you want to change, the category is actually really difficult to change and they're not often changed. It's a huge process as you imagine with the FDA. So what is happening in lieu of that? So in lieu of that, um in december of 2000 and 14, the FDA published something called the P. L. L. Are ruling which is the pregnancy and lactation labeling rule. What this requires is the new medication and some old medication to change the content in the format of the information presented for prescription drug labeling so that physicians would be better informed but also patients would be better informed. So the drug label all of a sudden doesn't have a small section about pregnancy and lactation and has much much bigger section pregnancy lactation, it is supposed to give more information. And even though it's a little bit more time consuming to get that information, it is more accurate. Um And this is important because a lot of, a lot of I guess medical legal issues have occurred in, a lot of terminations have occurred in a lot of worry and concern have occurred by using the FDA categories. Um This is all it's saying that we're removing the FDA categories A. B. C. D. N. X. And we're requiring actually to have language in there that is readable and understandable. So this is the part about sources of information. Uh This is the part that I hope can help help you and finding information because it's nice to get a nice little overview and the taste of what birth defects research and counseling is like. But how do you actually get help with your patients? The journal articles obviously are a great source of information but not ideal. I mean they do uh require a lot of work a lot of time time consuming to be able to look up all of these things and and uh get the data that you need. Text books are great. These are actually to the text books that I like a lot. But textbooks as soon as they are written and published are automatically out of date. So you have to keep on top of that that is being republished again. Uh The new editions are coming out and you have to stay on top of that. It's it's a little bit challenging. Their computer prize databases and these are the ones that I like report toxin terrorists have computer are computerized databases where it's a little bit like up to date where you can put in the medication like La Vida law and we'll give you a summary of the exposure in pregnancy and lactation. I know these are always updated. Um And with actually a pretty good frequency that you can, if you're at T. G. H. You can find report talks under an epic. Um There's an icon for that. You can find an epic and I'll show you some other ways. You'll be able to get it the the lacked med. It's actually free and you can just search that google laxman and you'll get a basically database that is for lactation. So it's not for pregnancy but it is for lactation and it has up to date information as well. The one caveat today's to this is that there there is lost government funding for keeping up the locked med app. And so the app is not updated but lack met on the internet is so this is an example of report talks and what it looks like. Um And you can put in whatever medication you wanted or exposure and you'll get a summary like this. Um The one really nice thing I wanted to point out is that it does cost money. So institutions will often have them more practices will often have them, but you can use the contact us button on the top right corner and if you have somebody who's in training, uh, you know, medical student or something like this, you can actually get access that way because trainees get it for free during the time of their training. Um the other thing that, and this is a name, a bit proud of is what we call it, tear it. Ology Information service, so tautology information service or A. T. I. S. Um And another name for the public. His Mother to Baby is an organization um that actually has 14 sites in the United States and ours here in the U. S. F. T. G. H. Is one of them. And what it is is basically a resource for the community and for that particular state. And because there's only 14 sometimes for multiple states, what it is, you can call it as a provider or as a physician, you can call a phone number and you can get to speak to a tragic information specialist. So people have had training in counselling and um exposure medicine too, just like you would maybe for poison control uh and you can speak to somebody either through chat or through email or to phone and discuss what is your particular exposure and what is your particular risk again? Open to all physicians to healthcare providers and patients free of charge also. Um through this, um, Um, you can also get a lot of information for your patients. If you go on the website, there's more than 300 fact sheets that are done uh to kind of question and answer for patients, let's say it's love it all and you want to look at if you can look up with that information and it'll spit this up for you and you can print it out and give it to your patient. And it's based on the seventh grade reading level and gives a talks about preconception and pregnancy and breastfeeding. We have it in english and in spanish and these are updated very frequently as well. So the other service here is one of these 14 centers that we have in the U. S. Um ours is the only one that does also see patients in person. We do telehealth visits and we see patients in in person. And we provide this free of charge access to us through a phone line and through email. And I have hired wonderful genetic counselors, prenatal genetic counselors who are well versed and trained in exposure medicine and obviously are exceptional and counseling. And what we do is we have a clinic before Covid. We actually had a clinic about seven half days a month. What we were seeing patients with exposures in pregnancy and now we do all of them by telehealth in some in person. Obviously they can come with an ultrasound or not and they're always seen by an N. F. M. And it's me because we want to make sure that they get the appropriate answers in care. And obviously the information that is transcribed is a very long letter risk assessment. So it takes a little bit of that risk and ownership off of the main provider and obviously available for any questions and discussions uh what we talked to our patients about, we get a lot of information, a lot of questions about exposures such as psychiatric medications, infections. But we can really do anything. We can do paternal exposures. There's a whole body of evidence on paternal exposures. Uh, so it's not as great as my maternal exposures, but we have a lot to talk about there as well. But anything tobacco use alcohol use exposures in the workplace such as lead. And we had a patient exposed to mercury and the patient exposed many patients exposed to pesticides. But again, other agents that we already spoke about radiation and heat, hypoxia, etcetera. So this is all what a dermatologist is. I guess I'm a tear Atallah gist. But there's so many people who would fall into this category. Uh those of us who are looking for defects and how to best take care of them. Epidemiologists and scientists, um and those who do animal studies, et cetera, all of that are really important aspects of what we do. So thank you so much for your attention. This is the way to actually get ahold of me. If you have any questions that if you have any comments about anything tonight, anything I can help with, you can follow us on twitter, you can ask us through our email and be able to help. Would be happy to help you or any of your patients. Thank you so much for your attention. If there's any questions I'd be happy to answer. Yes. We have a couple of dr a baton first. What kind of medicine exposures do we see the most? I think one of the greatest things we do see a psychiatric medication. So psychiatric medications tend to be what healthcare providers tend to be nervous about the most. Uh, and have questions about maybe their medical legally concerned about it. Maybe the patients are concerned about it. And we we would much rather the patient not stop all her medications before they see us, because it's very important to talk about the risk benefit of the medication exposure, um and make some decisions that are the best for her family. That's probably our biggest contributor. Um sometimes um antibiotics and sometimes um uh antonia plastic agents. So patients who have cancers have come to us for radiation and chemotherapy. Excellent. And another one about medication. What kind of follow up is recommended for exposure to certain types of medicine, like ultrasounds, mris, et cetera. Yeah, so that's a great question. So, for depends on the exposure. So, if we have a patient who's been exposed to alcohol and significant alcohol intake, so we're worried about fetal alcohol syndrome. I sometimes can't find fetal alcohol syndrome on ultrasound, but ultrasound is a great way to look at things like cardiac defects. So, yes, to ultrasound, it looks for issues with growth as well. So you can do serial ultrasounds to look for growth abnormalities. Fetal echocardiography is the big one, and sometimes mris is specifically when it has to do with neuro defect is very helpful for telling our patients exactly what to expect. Great, super helpful. Thanks so much. And I have one more question in A. Q. And for the audience, if you have any other questions or comments while dr Overton answers this last one, please use this time to type them into the chat box and we'll be sure we have 10 minutes left. So we have time for more if you feel like and you would like to mention anything now is the time. So, the question that I have dr objection regarding FDA categories, um we're to find the info on what's not being used anymore. It's a good question. FDA actually has some great resources online. Um in terms of the FDA categories and you can get the newest information by going to the FDA website and um looking at the medication in question and it will give you if they have it if it's uh if it's been requested from the company to change how the wording is, it will have that information online. The other way is to to contact us if there's any doubt or some things are difficult to find, we have resources to be able to find them for you and be able to send them over to you. Excellent. It doesn't look like any other questions have come through. So I'll use this time to thank everyone for joining us and thank you Doctor a baton for your time this evening. Thank you from everyone at T. G. H. And have a good rest of your night. Thank you for having me. Goodnight everyone. Published July 15, 2021 Created by
