Doctors have been warned that high doses of common painkillers such as ibuprofen can increase the risk of heart attacks.
The Commission on Human Medicines (CHM) has written to healthcare professionals informing them that non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of heart attacks or stroke when used in high doses over the long term.
It comes after the European Medicines Agency (EMEA) ruled that the benefits of non-selective NSAIDs still outweigh any increased risks. Yesterday, the agency's Committee for Medicinal Products for Human Use (CHMP), said it "cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment".
Nevertheless, it ruled that the "overall benefit-risk balance for non-selective NSAIDs remains favourable" when the patient’s history was taken into account and packet instructions were followed.
The commission said the findings did not call into question the value of the medicines, "but will enable updated information to be provided that will help healthcare professionals and patients to make informed choices about their medicines and treatment".
The makers of Nurofen defended the product and said it had a long history of use as a safe and effective medicine.
Dr Eric Teo, UK medical director of Reckitt Benckiser Healthcare International, said: "Ibuprofen used in the short term at the low dose available over the counter (OTC) is not associated with an increased risk of heart attack.
"OTC ibuprofen, such as Nurofen, is used by millions of people around the world every day and the outcome of this latest EMEA data review confirms what we have always known – ibuprofen has a good safety profile when taken intermittently at low dose available OTC.
"The general public should remain reassured when purchasing ibuprofen in the OTC setting for minor ailments and have no concerns about its safety."
Ellen Mason, cardiac nurse at the British Heart Foundation (BHF), said: "There has been a mounting body of evidence that taking high doses of non steroidal anti-inflammatory drugs (NSAIDS) increases the chances of having a heart attack. However, the increased risk is small and the EMEA have concluded that it is outweighed by the benefits of pain-relief for patients with conditions such as arthritis.
"We welcome their recommendations that most people should use the lowest dose of NSAIDs for the shortest amount of time possible.
"We are pleased the EMEA will continue to review the use of NSAIDs."
The Medicines and Healthcare products Regulatory Agency (MHRA) will now ask manufacturers to update their product information for NSAIDs based on the recommendations from the CHM and CHMP.
Dr June Raine, director of vigilance and risk management of medicines at the MHRA, said: "NSAIDs are important medicines and the balance of benefits and risks remains positive.
"The lowest effective doses of NSAIDs should be taken for the shortest time necessary for control of symptoms.
"There is no need for patients to stop taking their medicines and there is no need for patients to switch between NSAIDs if they are well. Anyone who is concerned should talk to their doctor."