The Medicines & Healthcare Products Regulatory Agency (MHRA) said patients who are prescribed statins should continue to take them, despite articles in the British Medical Journal (BMJ) this year that said they could cause harmful side-effects and did not cut death rates.
The MHRA’s monthly “drug safety update” yesterday said latest evidence from large clinical trials has shown statins can save lives by reducing the risk of heart attacks, strokes and the need for heart surgery.
Statins are commonly prescribed for people at risk of heart attack because of their cholesterol-reducing properties, with as many as seven million patients thought to be using them regularly in the UK.
Earlier this month, the BMJ said it was setting up a panel of experts to decide whether it should completely retract two articles which suggested the drugs presented the risk of serious side-effects without a realistic prospect of cutting death rates.
The papers prompted a row, with one expert calling them “misleading”.
Writing in the drug safety update yesterday, the MHRA said most side-effects experienced by people who take statins are mild, and muscle-related problems are the most frequently reported issues.
Product information lists advice about how to use statins and any potential side-effects, it said.
Dr June Raine, the MHRA’s director of vigilance and risk management of medicines, said people should continue to take their statins as prescribed.
She said: “Large clinical trials have shown that statins can save lives by reducing the risk of heart attacks, strokes and the need for heart surgery.
“We will update the prescribing advice for statins in light of any substantial new evidence of safety concerns.
“If patients have any concerns about their medicines then they should speak to their doctor.”
She said anyone suspected to be experiencing side-effects should report it to the MHRA through the “yellow card scheme”, used to collect information on drugs, at www.yellowcard.mhra.gov.uk.
Statins are a group of medicines that target so-called “bad cholesterol” in the blood. People can lower their risk naturally by eating a diet low in saturated fats, and increasing the amount of omega 3 fatty acids.
The NHS estimates that statins save 7,000 lives a year.