Wednesday, September 28, 2011

Painkiller heart alert: Don't stop taking pills, but do talk to your GP, British scientists urge

For once they mention the absolute risk and admit that it is tiny

A painkiller taken by millions can increase the risk of heart attack and stroke by 40 per cent, a study has found. Researchers say that while there is no need for patients to panic, diclofenac should be restricted to prescription only.

In completely healthy patients, a 40 per cent raised chance of heart problems is not at all significant. But for those who already have a high risk of a heart attack or stroke, taking the painkiller could present serious problems.

Last night the Medicines and Healthcare products Regulatory Agency (MHRA) said that patients should not stop taking the drug, but should consult their doctor if they have fears over its safety.

Last year almost 17million prescriptions were written by GPs in England for non-steroidal anti-inflammatory drugs, or NSAIDs, for conditions such as arthritis, back pain, gout, headaches and fever. Of these, diclofenac was the most commonly prescribed and given to 6million patients. It can also be bought over the counter under the brand name Voltarol Pain-Eze for around £6. It is at lower strength but still carries a 22 per cent higher risk.

Dr Patricia McGettigan of Hull York Medical School, who led the landmark review of studies looking at nearly 3million people, said: ‘Diclofenac on prescription was associated with an increase in cardiovascular risk of 40 per cent.

‘People take it because it’s effective, but it’s very important for patients and doctors to know the risks associated with these drugs for high-risk patients. ‘It is now available over the counter, and our study suggests there is a case for looking at that again and making it prescription-only as well as strengthening advice to doctors and patients about how it should be used.

‘There is a very clear increase in risk as the dose goes up, which says to people who perhaps can’t get out of bed due to arthritis and take diclofenac, take a different drug instead and you might be at a lower risk of heart attack and stroke. ‘We have reviewed all the previous studies and are confident that the results are robust enough to inform clinical and regulatory decisions.’

This is the first study to measure the relative risks of different drugs, and it found that ibuprofen and naproxen had the lowest risk of cardiovascular problems.

Many patients were transferred to diclofenac from Vioxx, the painkiller which was withdrawn by manufacturer Merck in 2004 after it was linked to heart attacks and strokes.

Patients will often be at minimal risk. For a young woman, the risk of having a heart attack will be around 0.1 per cent and a 40 per cent rise is still just 0.14 per cent. However for a pensioner who has already had one heart attack, a 40 per cent increase could be significant.

Doreen Maddock of the British Heart Foundation said: ‘The potential risks for heart patients taking certain painkillers have been known for some time and these findings shouldn’t be ignored. But scientists and drug regulators will need to delve deeper before we draw any firm conclusions.

‘As with any medicine there are benefits and potential risks to taking painkillers. If you’re already taking these types of drugs and are worried, don’t simply give up on your medication. You should always speak to your doctor first because the benefits may well outweigh the risks for you.’

A spokesman for the MHRA said: ‘Our priority is to ensure that the benefits of medication outweigh the risks. NSAID treatment is associated with a small increased risk of heart attacks and stroke. The risk is higher with long-term treatment.

‘Clear warnings about the risk of gastro-intestinal and heart problems, along with information about those patient groups in which NSAIDs either should not be used, such as those with severe heart failure, or only used with caution, are contained in the product information including the patient information leaflet that accompanies the medicine.

‘To minimise the risk of side effects, all NSAIDs should be used at the lowest possible dose for the shortest period necessary to control symptoms. ‘People should not stop taking their NSAID medicine, but if they have any questions or concerns about their treatment they should speak to their doctor. ‘The MHRA keeps the safety of NSAIDs under close review and any new data will be carefully evaluated.’

A spokesman for Novartis, which makes Voltarol, said: ‘In our view, this analysis, in the context of the vast clinical experience worldwide, does not change the favourable benefit-to-risk assessment for diclofenac when used as directed. ‘Novartis is confident about the safety profile of diclofenac products.’


Good news for fathers: Having children reduces a man's risk of heart disease by 20%

I think this just means that healthier men are more likely to have children -- and possibly for social rather than medical reasons

It may come as a surprise to father's continually woken by their offspring in the early hours of the morning, but having children could mean they have healthier hearts.

A decade-long study of 135,000 men found that those who remained child-free had a higher risk of dying from heart disease than those who 'sowed their oats.'

U.S researchers said it raised the possibility that infertility may be a potential early warning sign of future heart trouble.

'There is emerging evidence to suggest that infertility may be a window into a man's later health,' said study leader Dr Michael Eisenberg of Stanford University in California.

He said men who are infertile have a higher risk of certain cancers, and his team wanted to look for other signs that infertility might be playing a role later in a man's life.

The researchers, reporting in the journal Human Reproduction, followed more than 130,000 men who were retired and over 50 for a decade.

They restricted the list to men who were either married or had been married because they wanted to compare males who had the intent and the opportunity to have children.

Men with previous underlying diseases, such as stroke, heart disease or some related condition were excluded. Hence, the men in their list started off in relatively good health.

Over the course of the 10-year follow up period, some 10 percent of the men died, and one out of every five of these deaths was from heart disease.

When looking at the parental status of these men, childless participants in the study had about a 17 per cent higher risk of heart disease than those who were fathers.

Dr Eisenberg said it was not possible to determine whether men in the study simply chose not to have children or whether the men's partners were infertile.

But excluding unmarried men offered an approximation of male infertility, and the link to heart disease raises important questions that merit further research. 'My belief it there is a biologic reason,' he said.

The researchers stress that the study does not suggest being childless causes heart problems, but since infertility affects a man's health at a much younger age, understanding this link could help doctors identify heart problems earlier, when there is more time to intervene.


1 comment:

John A said...

NSAIDS - "patients should not stop taking the drug, but should consult their doctor if they have fears over its safety."

Is this not true of any [prescribed] drug? Especially if you get prescriptions from more thsn one doctor? Why single out this one [type]?

Oh, and not just drugs. One warned me that grapefruit (but not other citrus, such as lemon) would almost nullify one of the prescriptions I take. Pity, I had to stop using one soft drink I like.

And of course, every doctor - into double digit numbers - I have ever consulted has told me to exercise for weight management. That is, all but one: he said that the guidelines said he MUST do so, but he would not because even the "moderate" exercise he was supposed to recommend could exacerbate one or more of my problems to life-threatening levels. He did, true, mention some alternative forms to the standard oes he was suposed to try to bully me into...