Sunday, October 26, 2008

Some users of slimming drug at risk of psychiatric disorders

One hundredth of one percent is a worry?? I would have thought that a drug which 99.99% of people use without suffering severe side-effects was a triumph of safety! All drugs have side-effects. I know one lady who had acute renal failure after taking the common antibiotic Keflex (cephalexein). Maybe we should ban that too! And aspirin would never have been approved under current guidelines

An anti-obesity drug that has been prescribed to 97,000 people in the UK doubled the [tiny] risk of psychiatric disorders in those who took it, the European Medicines Agency has found. The EMA has decided that the benefits of the drug Acomplia - which has been licensed in Europe since June 2006 - no longer outweigh the risks, and have advised doctors to no longer prescribe the drug. In a trial of 36,000 this summer, five of those taking the drug [i.e. 0.01%] committed suicide, compared to only one of those taking the placebo.

Acomplia, whose active substance is rimonabant, has been available on the NHS since June this year. It works by suppressing the appetite. During clinical trials, one third of patients lost more than 10% of their initial bodyweight in a year. Nearly two thirds of patients lost over 5%. The drug is prescribed for people who are clinically classified as obese, or those who are overweight and suffer from problems like type 2 diabetes and a high cholesterol.

Warnings about the side effects of the drug-- which can cause depression-- have been known since the drug was introduced. It is only now however, that it has been decided that these side effects make the drug too dangerous to prescribe. Following a re-evaluation of the drug, the EMEA said that "there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients."

The EMEA, and their UK counterpart the Medicines and Healthcare products Regulatory Agency (MHRA), have recommended that the drug is no longer prescribed, and said that those currently on the drug- thought to be about 20,000 in the UK- should consult a doctor about their treatment. The MHRA is alerting healthcare professionals about the recommendation. The MHRA said: "Patients who may be at highest risk of psychiatric reactions cannot be identified reliably. Therefore, further restrictions on the use of this medicine would be unlikely to reduce the risk to an acceptable level."

There are three main anti-obesity drugs prescribed in the UK- Acomplia, Sibutramine, and Orlistat. Acomplia is prescribed in for about 9% of cases, whereas Orlistat, approved by the EMEA in July 2007, is prescribed in 66% of cases. The manufacturer of the drug, Sanofi-Aventis, said: "Sanofi-Aventis will comply with the European authorities' request to temporarily suspend the marketing authorisation of Acomplia in obese and overweight patients and will make every effort to actively support patients and healthcare professionals in this process." They said that the drug had provided "significant clinical benefits to patients" and that 700,000 people worldwide had used the drug.

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said : "Most medicines work well and are acceptably safe and most people take medicines without suffering any side effects. The MHRA and the EMEA work together to continuously monitor the safety and quality of medicines after they have been licensed, and use a range of approaches to minimise risk. "In the case of Acomplia these measures have not proved to be effective in clinical use.


A stroll in the park is as good at calming children as Ritalin, study finds

This does not seem to have been double-blind so could well be a Rosenthal (experimenter expectation) effect

A stroll in the park could be just as effective for treating hyperactive children as drugs such as Ritalin, a study has revealed. Troubled youngsters showed significant improvements in concentration levels after what researchers called 'a dose of nature'. A 20-minute walk in green surroundings gave improvements on a par with a daily dose of drugs for Attention Deficit Hyperactivity Disorder, or ADHD.

Record levels of medicines are being dished out to hyperactive children on the NHS. Latest figures show GPs wrote more than 535,000 prescriptions for anti-hyperactivity drugs last year - more than 10,000 a week. The figure has doubled since 2002. Critics have accused doctors of using such drugs as a 'chemical cosh' to calm thousands of youngsters thought to have ADHD, a condition that makes them inattentive or boisterous and unable to concentrate at school. Roughly one child in every classroom is thought to be affected by ADHD.

In the latest study, researchers at the University of Illinois took a group of 17 hyperactive children on three walks in a park, town centre and residential area. The children stayed off their medication that day so researchers could be sure any benefit was from the environment alone. The youngsters were tested on their powers of concentration after each walk.

After strolling in green areas, their scores were improved by as much, if not more than, when they took prescription drugs. But the same children did not get any benefit from walking through town centres or residential streets. Researcher Andrea Faber Taylor said: 'The greenest space was best at improving attention. 'We calculated the size of the effect in our study and compared it with the size of effect in a recent study involving medication. 'We were surprised to see the "dose of nature" had effects the same size or even larger than those of drugs. 'We can't say for sure that two hours of outdoor play will get you this many days of good behaviour. But we can say as little as 20 minutes could potentially buy you an afternoon, or a couple of hours, to get homework done.'

Andrea Bilbow, from the National Attention Deficit Disorder Information and Support Service, said it was a well-known fact that fresh air and exercise could calm down a child.

But she stressed: 'You cannot possibly alter the structure of the brain by going out and looking at trees. There is no good evidence that this is as effective as drug treatment.'


1 comment:

Anonymous said...

I would urge caution in using the suicide states for rimonabant as measures of safety. The trials had 47% people drop out for effects that the authors didn't include in their published papers, and over a quarter of the remaining patients on the full dose were experiencing psychiatric symptoms. Suicide is not the only or best safety measure and greatly underestimates the full story.