Original post through Mother to BabyBy Mara Gaudette, MS, CGC, Teratogen Information Specialist, MotherToBaby CaliforniaThe chat message came through promptly at my 9AM start time. Her words and exclamation marks clearly highlighted her anxiety. “Just found out I’m pregnant! Taking Lipitor (atorvastatin) for cholesterol control since 6th grade! Talked to my doctor and stopped taking it yesterday, but what damage have I already done!? I know it’s a class X drug! Need info – please help! Julie.” She agreed to a phone call and I logged off from our MotherToBaby live chat service and phoned Julie.First you may wonder why someone would be on a cholesterol lowering medicine since late elementary or middle school. Isn’t that extreme? Actually no, in Julie’s case she has an inherited condition called familial hypercholesterolemia – or “FH” for short. This is a condition that occurs in about 1 in every 200 to 500 persons and is underdiagnosed and therefore undertreated. A simple blood test checking cholesterol levels and a review of your family history (such as checking for heart attacks at young ages or sudden unexpected deaths) can help determine if you have FH. Rarely, a more severe form of FH, inherited from both parents, can occur.To back up a bit, cholesterol is that fatty substance in our bodies that is needed, but too much cholesterol increases our risks for early heart disease. The lifestyle changes that are recommended to all of us, such as exercising regularly, avoiding smoking, and eating a healthy diet are also part of the treatment plan for FH (and Julie had been working hard to follow these guidelines). But medicines (like Lipitor®) are still a needed part of treatment because lifestyle alone won’t bring cholesterol levels down to normal in people with FH. For some with FH, medicines like Lipitor® may be prescribed starting as early as 8-10 years old.But what about the “category X” classification Julie mentioned-does this mean Lipitor® is absolutely proven to increase birth defects? Fortunately, for Julie the answer is a resounding “no!” Many women (and likely some health care providers) are not aware that the FDA decided in 2014 to phase out their letter category rating system. While an easy system to use, it was not necessarily a reliable system to predict pregnancy risk (see our January 2015 blog for more information).So why was Lipitor® assigned that old category X? Well, the developing baby needs cholesterol to form properly so there is a theoretical concern that cholesterol-lowering medicines could pose pregnancy risk. For many women, stopping a cholesterol-lowering medicine in the short term of a pregnancy is unlikely to significantly increase their heart disease risks. However, for some women, particularly those with the more severe form of FH, avoiding all cholesterol treatments could pose risks to both mom and baby. So if you have FH, talking with your cardiologist and obstetrician about a cholesterol treatment plan is important when planning a pregnancy or at least when you learn of your pregnancy.Most studies with Lipitor® and some similar medicines in this class of drugs called “statins” have not found an increase in birth defects with accidental use early in pregnancy. This should provide some reassurance to women who were taking statins before they realized they were pregnant, like Julie. (For more info, see our fact sheet on Statins in pregnancy.)“What about my FH then? I know pregnancy will further raise my cholesterol levels – will my high cholesterol harm the pregnancy?” Julie asked. She was already aware that children born to a parent with FH would have a 1 in 2 chance to inherit FH and would be screened in childhood. So we discussed a registry study from Norway in women with the less severe form FH that found no increase in birth defects or pregnancy complications compared to women without FH.“I feel a little better. But I wish there were more pregnancies followed – more than one study anyways. Women like me need more info about the medications we have to take!” she said. At MotherToBaby, we completely agree! And I appreciated Julie’s lead to bring up our follow-up program. I let her know that in addition to providing information, we have a study team that follows pregnancy outcomes. This will allow us to provide more information to nervous moms (and dads) and their healthcare providers. And one current focus is actually on high cholesterol and their treatments during pregnancy. We are looking for women who have high cholesterol, whether they take medicine or not, and even women who do not have high cholesterol – there is a role for everyone! If you find yourself like Julie drawn to the importance of this information and wondering how you can contribute, call 877-311-8972, email firstname.lastname@example.org or you can volunteer for a study through our website. There is no cost to participate and moms to be are never asked to take a medicine.
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