A major scientific study has revealed that cholesterol-lowering drugs known as ‘statins’ are not responsible for most of the side effects listed on drug leaflets, confirming that millions of people around the world may be being deprived of important health benefits due to decades of misleading information.
The study, published in the medical journal The Lancet, said it provided “irrefutable and compelling evidence” that statins do not cause many of the health conditions with which they have been associated, including memory loss, dementia, depression, sleep disturbances, weight gain and general fatigue.
Misinformation keeps millions of people out of treatment
Oxford University researchers have confirmed that years of inaccurate warnings may have kept millions of patients avoiding taking these daily drugs, despite their effectiveness in reducing the risk of heart attack and stroke by up to 50% in those most at risk.
Experts have called for a comprehensive review of drug labels and NHS guidelines to ensure patients and doctors are informed of new discoveries that could significantly change medical practice.
Broad scientific evaluation
Professor Brian Williams, chief scientific and medical officer at the British Heart Foundation, said the study was an “exceptional assessment of the best available evidence”.
“No one denies that patients can suffer from health symptoms at different stages of life, but the real question is: Are these symptoms caused by drugs? In most cases, the answer is no.
He noted that this is a strong message to send to the public and patients, and could cause the six to eight million people who would be taking statins to reconsider their stance on statins, noting that many of the symptoms plaguing patients are unrelated to taking statins.
He added that about 50% of patients who could benefit from these drugs are currently not receiving them.
Numbers and wide range of applications
Atorvastatin was the most prescribed statin drug in the UK in 2024/25, with 73 million prescriptions filled and around 8 million people in the UK estimated to be taking these low-cost drugs, which work to reduce the production of harmful cholesterol (LDL) in the liver, according to NHS prescribing data.
The National Institute for Health and Care Quality estimates that up to 15 million more people could benefit from statin therapy in 2023.
See data from 150,000 participants
The Oxford Population Health research team analyzed data from more than 150,000 people who took part in 23 randomized controlled clinical trials, the gold standard for assessing the effectiveness and safety of medicines.
Although the drug’s leaflet listed dozens of potential side effects, the study showed that of the 66 unwanted side effects previously associated with statins, only four were actually related to the drug.
No increase in memory loss or depression
Study leader Professor Christina Rees said: “There are no significant additional risks from statins for most of the conditions listed as potential side effects.”
She added that the study did not detect increases in memory loss, depression, sleep problems, erectile dysfunction, weight gain, nausea, fatigue, headaches, or a number of other symptoms.
She explained that these health problems are common in nature and can occur whether or not someone is taking a statin, but the results prove that the drug does not increase their incidence.
limited side effects
The study, published in The Lancet, found that statin users had a very small increase (0.1%) in abnormal liver function test results, but no increased risk of liver disease or liver failure.
A previous analysis by the same team also showed that about a quarter of participants developed muscle pain symptoms regardless of whether they were taking a statin or a placebo, indicating that these symptoms were not necessarily caused by the drug.
Small increases in blood sugar levels have also been recorded and may lead to early diagnosis of diabetes in people who are already exposed to it.
Call for change of medicine leaflet
Professor Rees pointed out that many of the side effects listed in the leaflet were based on unreliable observational studies, adding: “When you read a drug leaflet, you may be surprised that people are still taking the drug at all.”
He called on regulators to reconsider how drug labels are written to ensure they accurately reflect the true benefits and risks.
Statins and their role in extending life
Professor Williams highlighted that statins have played a vital role in the huge increase in life expectancy in the UK in recent decades, noting that prevention through lowering cholesterol, managing blood pressure and quitting smoking has revolutionized community healthcare.
Reassuring opinion
Dr Emily Herrett, from the London School of Hygiene and Tropical Medicine, said the evidence was “reassuring for patients and doctors”, explaining that the symptoms that appear while taking statins probably would have occurred even without the drugs.
Professor Riad Patel, a consultant cardiologist at University College London, stressed that these results “should be made available to everyone who takes or prescribes statin drugs because it alleviates a lot of the fear.”
A major scientific study has revealed that cholesterol-lowering drugs known as ‘statins’ are not responsible for most of the side effects listed on drug leaflets, confirming that millions of people around the world may be being deprived of important health benefits due to decades of misleading information.
The study, published in the medical journal The Lancet, is said to provide “irrefutable evidence” that statins do not cause many of the health conditions previously associated with statins, including memory loss, dementia, depression, sleep disturbances, weight gain and general malaise.
Millions of people were deprived of treatment due to misleading information
Oxford University researchers have confirmed that years of inaccurate warnings may have led millions of patients to avoid taking these daily drugs, despite their effectiveness in reducing the risk of heart attack and stroke by up to 50% in high-risk patients.
Experts are calling for a comprehensive review of drug labeling and NHS guidelines to ensure patients and doctors are informed of new findings that could lead to major changes in medical practice.
widespread scientific praise
Professor Brian Williams, chief scientific and medical officer at the British Heart Foundation, said the study was an “exceptional assessment of the best available evidence”.
He added: “No one denies that patients can experience health symptoms at different stages of life, but the real question is: Are these symptoms caused by the drug? And in most cases, the answer is no.”
He noted that many of the symptoms patients are concerned about are unrelated to taking statins, and thought this was a strong message to send to the public and patients, potentially causing the 6 million to 8 million people who would be taking statins to reconsider their stance on statins.
He added that about 50% of patients who could benefit from these drugs are currently not receiving them.
Numerical and extensive use
According to NHS prescribing data, atorvastatin will be the most prescribed statin in the UK in 2024-25, with 73 million prescriptions issued and around eight people in the UK estimated to be taking these low-cost drugs, which work by reducing the production of harmful cholesterol (LDL) in the liver.
The National Institute for Health Research Excellence has suggested that up to 15 million more people could benefit from statin treatment in 2023.
Review of data from 150,000 participants
The Oxford Population Health research team analyzed data from more than 150,000 individuals who took part in 23 randomized controlled trials, the gold standard for assessing the effectiveness and safety of medicines.
Despite the drug’s leaflet listing dozens of potential side effects, the study showed that of the 66 side effects previously associated with statins, only four were actually proven to be related to the drug.
No increase in memory loss or depression
Study leader Professor Christina Rees said: “There are no significant additional risks from statins for most of the symptoms listed as potential side effects.”
She added that the study found no increases in memory loss, depression, sleep disturbances, erectile dysfunction, weight gain, nausea, fatigue, headaches, or a number of other symptoms.
She explained that these health problems are common in nature and can occur whether or not someone is taking a statin, but the results show that the drug does not increase their incidence.
limited side effects
The study, published in The Lancet, observed a small increase (0.1%) in liver function test abnormalities among statin users, and no increased risk of liver disease or liver failure.
A previous analysis by the same team showed that about a quarter of participants developed muscle pain symptoms regardless of whether they were taking a statin or a placebo, indicating that these symptoms were not necessarily caused by the drug.
Even small increases in blood sugar levels have been recorded, which may lead to an early diagnosis of diabetes in people who are already at risk.
Request changes to drug leaflets
Professor Rees pointed out that many of the side effects listed in leaflets were based on unreliable observational studies, adding: “When you read a drug leaflet, you may be surprised that people are still taking the drug.”
She called on regulators to rethink how drug labels are written to accurately reflect the true benefits and risks.
Statins and their role in extending lifespan
Professor Williams highlighted that statins have played a vital role in the huge increase in life expectancy in the UK in recent decades, noting that prevention through lowering cholesterol, managing blood pressure and quitting smoking has revolutionized community healthcare.
Reassuring opinion
Dr Emily Herrett, from the London School of Hygiene and Tropical Medicine, said this evidence was “reassuring for patients and doctors”, explaining that symptoms that occur while taking statins are likely to occur without the medication.
Meanwhile, Professor Riyadh Patel, a cardiology consultant at University College London, asserted that these findings “should be made available to anyone taking or prescribed a statin, as they alleviate many concerns”.
