Pravastatin and pregnancy: safety for your baby
Because of its potential benefits, during the past couple of decades, Pravastatin has been tested during pregnancy in studies which investigated whether Pravastatin prevents or treats problems in pregnancy such as preeclampsia1-4 and antiphospholipid syndrome5. In these studies, there were no safety concerns or problems regarding the baby’s development (number of pregnant women=1,303). In fact, these studies suggest that there may be benefits to the baby, as they found evidence that Pravastatin reduced the number of babies born early: this is what the PIONEER study will now test.
At present, the NHS does not endorse taking statins in pregnancy and currently recommends that women stop taking all statins (including Pravastatin) in pregnancy. Statins have previously been avoided in pregnancy as studies carried out decades ago suggested there could possibly be problems for the growing baby associated with taking statins. However, these studies did not include Pravastatin6-9. Better designed and more thorough studies have now shown that there is no evidence of problems for the growing baby from taking statins and there have been no safety concerns raised when Pravastatin has been used in pregnancy8,10,11. In addition, Pravastatin is a newer statin and is hydrophilic (which means it has a stronger attachment to water than fat particles) unlike older statins which were often more lipophilic (which means a stronger attachment to fat particles). Hydrophilic medicines cross the placenta less easily than lipophilic medicines9.
With this new and better-quality evidence available, in 2021 the USA Food and Drug Administration (FDA) removed its ban on use of statins in pregnancy. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs in the USA. The important decision to remove the ban has been followed by other studies, which in total have included 6,700 pregnant women who took statins in pregnancy, with no evidence of harm to the baby 8,12,13,14,15,16. The NHS in the UK has not currently changed their advice despite the change in FDA recommendations, however the PIONEER study may help provide the evidence to enable this advice to change.
We have included references to all these studies in case you would like to read the evidence for yourselves. You can also ask a member of the PIONEER central research team about these studies or if you have any further questions regarding this
Possible side effects for the person taking Pravastatin
Along with their useful effects, most medicines can cause some unwanted side effects for the person taking them. There have been previous reports that statin treatment can cause muscle pain or weakness. However, a study recently published in the scientific journal The Lancet analysed the results of over 20 large studies that compared muscle symptoms experienced by those taking a statin compared with those taking a dummy drug (placebo). The results showed that statin use caused only a small increase of mostly mild muscle pain, and that this small risk was lower than the benefits of statin treatment.17
Although most people do not experience these side effects, the table below lists all known side effects that have been reported to be associated with all statins (not specifically for Pravastatin). If experienced, these tend to be mild for most people.
If you experience mild side effects from the study medication, but you do not find them troublesome, then it is fine to continue taking the medication. Unwanted side effects often improve as your body adjusts to the new medicine. Please speak with the local research team if you are worried or concerned about any other possible side effects.
Uncommon: affect less than 1 out of every 100 people who take the medicine:
Effects on nervous system:
dizziness, tiredness, headache or sleep disturbances, including insomnia.
Effects on vision:
blurred or double vision
Digestive effects:
indigestion, nausea, vomiting, stomach pain or discomfort, diarrhoea or constipation and wind.
Effects on skin and hair:
itching, pimples, hives, rashes, scalp and hair problems (including hair loss).
Urinary and genital effects:
bladder problems (painful or more frequent urination, having to pass water at night) and sexual difficulties.
Rare: affect less than 1 out of every 1,000 people who take the medicine
Skin sensitivity to the sun
Very rare: affect less than 1 out of 10,000 people who take the medicine
Effects on nervous system:
problems with touch including burning or tingling sensations or numbness which may indicate damage to nerves.
Effects on skin:
a severe skin disease (lupus erythematous-like syndrome).
Effects on liver:
inflammation of the liver or pancreas; jaundice (recognisable by a yellowing of the skin and of whites of the eyes; very rapid death of liver cells (fulminant hepatic necrosis).
Effects on muscles and bones:
inflammation of one or more muscles leading to pain or weakness in muscles (myositis or polymyositis or dermatomyositis); pain or weakness in muscles, inflammation of tendons which may be complicated by rupture of tendons.
Abnormal blood tests:
increases in transaminases (a group of enzymes occurring naturally in the blood) which may be a sign of liver problems. Your doctor may want to perform tests periodically to check these.
Some possible reported side effects with unknown frequency
– Nightmares.
– Memory loss.
– Depression.
– Breathing problems including persistent cough and/or shortness of breath or fever.
– Muscle weakness that is constant.
– Liver failure.
– Myasthenia gravis (a disease associated with general muscle weakness including in some cases the muscles used when breathing).
– Ocular myasthenia (a disease associated with eye muscle weakness).
Allergic reactions and worrying side effects to be aware of
You should stop taking the study medication and seek urgent medical advice, via your GP, NHS 111, or 999 if life-threatening, if you experience any of the following:
Severe reaction |
• You have side effects that are severe such as unexplained or persistent muscle pain, tenderness, weakness or cramps, especially if at the same time you feel unwell or have a high temperature.
• In very rare cases muscle problems can be serious (rhabdomylosis) and can lead to a serious, life-threatening kidney disease. |
Severe allergic reaction |
• You have sudden severe allergic reactions including swelling of the face, lip, tongue, or windpipe which can cause difficulty in breathing.
• This is a very rare reaction which can be serious if it occurs. |
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