Statins

THE SAFETY OF STATINS DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Statins should be avoided in women who are pregnant or planning to become pregnant. They also should not be used in women who are breastfeeding.

What are statins?

Statins are medications that reduce the amount of cholesterol in your blood. They also lower your risk of heart attack, stroke, and heart disease. Types of statins that are available include: atorvastatin (Lipitor), lovastatin (Altoprev), rosuvastatin (Crestor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and pitavastatin (Livalo). These medications are only available by prescription from your doctor.

What are statins used to treat?

Statins are used to reduce the risk of stroke, heart attack, and heart disease in people who have a high risk for these conditions. They are also used to treat hyperlipidemia, a condition where the amount of cholesterol in your blood is higher than normal.

What does it mean to have high cholesterol?

Cholesterol is a fat that is carried through your blood by proteins. There are two types called LDL and HDL cholesterol. LDL cholesterol is often referred to as bad cholesterol and contributes to the buildup of fat inside your blood vessels. This fat can turn into a hardened substance, known as plaque, which narrows your blood vessels and increases the chance that you will have a stroke or heart attack. Statins decrease amounts of LDL cholesterol, total cholesterol, and other fats in your blood to reduce the buildup of plaque and lower your risk of a heart attack or stroke. Additionally, statins increase HDL cholesterol, which is good cholesterol that helps to remove LDL from the blood.

How do statins work?

Statins work by blocking a substance that is necessary to produce cholesterol in the liver. They also increase the breakdown of LDL cholesterol.

Statins are taken once daily with or without food. Consuming grapefruit juice, especially larger quantities of more than 1 liter per day, should be avoided when taking a statin because it can prevent the breakdown of the drug and result in dangerous side effects. Statins can rarely cause rhabdomyolysis, a serious condition resulting in muscle breakdown and possible kidney failure. If you experience muscle pain or weakness, or notice dark red or brown colored urine while taking a statin, you should contact your doctor immediately to ensure that you do not have this condition.

If I am taking a statin, can it harm my baby?

Statins are labeled by the FDA as not for use in women who are pregnant or may become pregnant. There is concern that statins can harm your baby by decreasing cholesterol, which is necessary for your babys proper development. Evidence conflicts as to whether statins taken during pregnancy increase the risk of birth defects. Some evidence has indicated that statins may be associated with birth defects or health problems in the baby. However, other studies have not found an increased risk with their use. Temporarily discontinuing a statin during pregnancy will likely not interfere with their long-term benefits. Therefore, the risks to your baby usually outweigh the benefits of using statins during pregnancy. Until more evidence is available, it is recommended to discontinue statins during pregnancy and prior to conception. 

Evidence:

One review looked at 52 cases of statin exposure during the first trimester of pregnancy that were reported to the FDA between 1987 and 2001. There were 20 reports of birth defects, including 5 defects in the limbs and 5 severe defects of the brain or spinal cord. Most of these cases involved lovastatin, simvastatin, and atorvastatin. The reviewers did not associate statins with an increased risk of birth defects, but they did highlight the importance for more studies to analyze the effects of these drugs during pregnancy.     

Another study analyzed data from 64 expecting moms who were taking a statin during the first trimester of pregnancy and 64 who were not. They found no increased risk for birth defects, stillbirths, or abortions in expecting moms taking statins. However, they did find that statins were associated with reduced weight at birth. The study concluded that if there is a risk of birth defects with statins, it seems to be small. They also emphasized the importance of further studies on the safety of statins during pregnancy and recommended that women who become pregnant while taking a statin have an ultrasound to screen the baby for possible birth defects.

Several other studies have found that statins were not associated with an increased risk of birth defects when used during pregnancy. These studies analyzed data from: 225 expecting moms exposed to simvastatin or lovastatin, 64 expecting moms who used a statin during the first trimester, and 1,152 expecting moms who used a statin during the first trimester of pregnancy.

Bottom line: Until there is more safety information, statins should be avoided during pregnancy and prior to conception.

If I am taking a statin and become pregnant, what should I do?

If you become pregnant while taking a statin, you should contact your doctor immediately. Your doctor will most likely discontinue your statin until after the birth of your baby.

If I am taking a statin, can I safely breastfeed my baby?

Statins are labeled by the FDA as not for use in women who are breastfeeding. There is concern that statins could pose a health risk in the breastfed baby by interfering with his or her fat metabolism. Additionally, rosuvastatin, pravastatin, and fluvastatin have been reported to pass into breast milk. Due to the lack of safety studies and the potential risks to your baby, it is recommended to avoid statins while breastfeeding. 

Bottom line: Statins should be discontinued while breastfeeding because they may pass into breast milk and disrupt your babys metabolism of fats.

If I am taking a statin, will it be more difficult to get pregnant?

No studies have been conducted on the effects of statins in women with normal fertility, but evidence has shown that they may impair fertility in men. Atorvastatin has been shown to negatively impact sperm in 17 men who took the medication for 5 months. This study was very small and more evidence is necessary before any conclusions can be made about the effects of statins on fertility in men. If you are planning a pregnancy and your male partner is using a statin, he may want to contact his doctor to determine if his statin should be temporarily discontinued.

If I am taking a statin, what should I know?

It is recommended to discontinue statins if you are trying to become pregnant or as soon as pregnancy is confirmed. There is concern that statins may decrease cholesterol in your baby which is necessary for his or her proper development. Additionally, there have been several reports of birth defects and health problems in babies exposed to statins. Although there is no clear association between statins and birth defects at this time, the potential risks to your baby outweigh the benefits of taking a statin while you are pregnant. You should contact your doctor if you are planning to become pregnant and are taking a statin. Your doctor will most likely discontinue your statin until after the birth of your baby.

Statins should be avoided while breastfeeding due to the potential risk to your baby and lack of safety evidence available. There is concern that statins could interfere with your babys fat metabolism. 

Statins may also interfere with a mans ability to father a child, although the exact risks are unknown.  If your male partner is taking a statin, he may want to contact his doctor to determine if his medication should be temporarily discontinued.

If I am taking any medication, what should I know?

T
his report provides a summary of available information about the use of statins during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry’s expert report about high cholesterol here.  Additional information can also be found in the resources below. 

Resources for statins during pregnancy and breastfeeding:

For more information about statins during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

Mayo Clinic: Statins: Are these cholesterol-lowering drugs right for you?

American Heart Association: HDL (Good), LDL (Bad) Cholesterol and Triglycerides.

 

Read the whole report
Last Updated: 31-01-2018
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.