Concern about the side- effects of the medicines - known as non-steroidal anti-inflammatory drugs (NSAIDs) - has increased, with a growing amount of evidence showing a link to heart problems.
October 25, 2006 (Press Release) --
NEW warnings are to be put on common painkillers such as ibuprofen after experts ruled they were linked to an increased risk of heart attack and stroke.
Concern about the side- effects of the medicines - known as non-steroidal anti-inflammatory drugs (NSAIDs) - has increased, with a growing amount of evidence showing a link to heart problems.
Now UK regulators have written to all doctors informing them of the dangers of high-dose, long-term NSAID use.
The Commission on Human Medicines has also asked drugs manufacturers to update the information they put on their products to highlight the small increased risk.
Millions of people in Britain take NSAIDs in high doses for conditions such as osteoarthritis and rheumatoid arthritis. The new warnings do not apply to low-dose ibuprofen bought over the counter at chemists.
Doctors and campaigners said the benefits of taking the drugs still far outweighed the risks, and that patients should not ditch their medication without speaking to their GP.
Last month, the European Medicines Agency launched an investigation into NSAIDs after studies showed there was an increased heart attack and stroke risk.
The agency's Committee for Medicinal Products for Human Use yesterday 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".
But it said that the overall "benefit-risk balance" remained "favourable" after taking into account the patient's history, such as previous heart problems.
As well as ibuprofen, the committee examined diclofenac, etodolac, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen and nimesulide. Piroxicam is still being assessed.
The Medicines and Healthcare products Regulatory Agency (MHRA) stressed that the warnings applied only to high doses of the drugs. For example, ibuprofen bought at a chemist comes in a dose of about 400mg per tablet. A high dose would be more than 2,400mg.
Research published earlier this year found high doses of ibuprofen and diclofenac could double the risk of heart attack.
The study, involving more than 140,000 patients, showed that, for every 1,000 people taking these drugs, three people a year would suffer a linked heart attack - twice the normal level.
Dr June Raine, of the MHRA, said: "The lowest effective dose 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 urgent need for patients to switch between NSAIDs if they are feeling well."
The new warnings follow the withdrawal in 2004 of Vioxx, another drug used to treat arthritis, over an increased heart attack risk. Thousands of patients were switched to NSAIDs instead.
Author: LYNDSAY MOSS
Source: http://news.scotsman.com/
Concern about the side- effects of the medicines - known as non-steroidal anti-inflammatory drugs (NSAIDs) - has increased, with a growing amount of evidence showing a link to heart problems.
Now UK regulators have written to all doctors informing them of the dangers of high-dose, long-term NSAID use.
The Commission on Human Medicines has also asked drugs manufacturers to update the information they put on their products to highlight the small increased risk.
Millions of people in Britain take NSAIDs in high doses for conditions such as osteoarthritis and rheumatoid arthritis. The new warnings do not apply to low-dose ibuprofen bought over the counter at chemists.
Doctors and campaigners said the benefits of taking the drugs still far outweighed the risks, and that patients should not ditch their medication without speaking to their GP.
Last month, the European Medicines Agency launched an investigation into NSAIDs after studies showed there was an increased heart attack and stroke risk.
The agency's Committee for Medicinal Products for Human Use yesterday 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".
But it said that the overall "benefit-risk balance" remained "favourable" after taking into account the patient's history, such as previous heart problems.
As well as ibuprofen, the committee examined diclofenac, etodolac, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen and nimesulide. Piroxicam is still being assessed.
The Medicines and Healthcare products Regulatory Agency (MHRA) stressed that the warnings applied only to high doses of the drugs. For example, ibuprofen bought at a chemist comes in a dose of about 400mg per tablet. A high dose would be more than 2,400mg.
Research published earlier this year found high doses of ibuprofen and diclofenac could double the risk of heart attack.
The study, involving more than 140,000 patients, showed that, for every 1,000 people taking these drugs, three people a year would suffer a linked heart attack - twice the normal level.
Dr June Raine, of the MHRA, said: "The lowest effective dose 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 urgent need for patients to switch between NSAIDs if they are feeling well."
The new warnings follow the withdrawal in 2004 of Vioxx, another drug used to treat arthritis, over an increased heart attack risk. Thousands of patients were switched to NSAIDs instead.
Author: LYNDSAY MOSS
Source: http://news.scotsman.com/
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