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SSRI's : Bad prescribing habits

MagazineApril 2009 (Vol. 20 Issue 1)SSRI's : Bad prescribing habits

Thousands of patients are being put at risk of life-threatening side-effects, including an increased risk of acts of self-harm such as suicide, because they are being given the drug beyond the point where it will do any good

Thousands of patients are being put at risk of life-threatening side-effects, including an increased risk of acts of self-harm such as suicide, because they are being given the drug beyond the point where it will do any good.

New evidence shows that, if the drugs are going to have any benefitat all, it will happen within the first two weeks of taking the drug. Conse-quently, many patients are being put at risk of lethal side-effects because the drug companies and doctors are recommending that the drugs be taken for at least six weeks, if not longer.

The conventional wisdom about the new antidepressants holds that it takes a little time for them to work. According to recent guidelines issued by Britain's National Institute for Health and Clinical Excellence (NICE), ". . . patients started on antidepress-ants should be informed about the delay in onset of effect".

This was certainly the clinical and laboratory experience with the older tricyclic antidepressants. The drug companies and scientists believed that this early generation of drugs worked quickly until the research proved otherwise. Animal models showed that the drugs only worked once the ani-mals (and, it was assumed, human patients) had developed an insensitivity in certain brain receptors.

A review of all of the studies in the scientific literature also confirmed a delay in the time it took the drugs to start kicking in (Arch Gen Psychiatry, 1984; 41: 782-6). In addition, many of the sophisticated theories concerning how selective serotonin reuptake inhibitors (SSRIs) worked all stressed this delay in onset.

Then, when the SSRIs were first launched, psychiatrists and researchers simply assumed the same delay would occur. The assumption of a lengthy time between the start of treatment and any actual effect underpinned the prescribing habits of doctors for all the years the SSRIs have been on the market.

However, after many years, the science has begun to challenge this basic assumption. A 2005 review of 76 double-blind, placebo-controlled studies of antidepressants discovered that nearly two-thirds of the improve-ment seen in patients took place within the first two weeks. Half of all patients who responded to the drug within asix-week period did so during the first fortnight (Am J Psychiatry, 2000; 157:1423-8).

Then, a review of the major placebo-controlled studies of SSRIs cast even more light on the timing of therapeu-tic benefit. This meta-analysis showed that the greatest period of therapeutic response occurs within the first week and that benefit declines with every week thereafter. In fact, one-third of the full effect of treatment is apparent in that first week (Arch Gen Psychiatry, 2006; 63: 1217-23).

This result jibes with the new neuroscience about the brain, which has found that the longer depressive thoughts remain unchanged in the brain, the more likely they are to become 'hardwired' in and the less likely is the person to respond to conventional treatment.

So worrying is this new finding that the US drugs watchdog, the Food and Drug Administration (FDA), has now issued a blanket mandate, instructing all manufacturers of SSRIs to update their black-box warnings. The new labelling must now include the warn-ing that young adults aged from 18to 24 taking these drugs may increase their risk of suicidal thinking and behaviour, even during initial treat-ment-the first month or two. Manu-facturers of all SSRIs are being given just 30 days to submit revised product labels and medication guides to the FDA for review.

The new labelling follows quickly on the heels of the 2005 black-box warnings issued by the FDA, which warned of the increased risk of suicide among children and adolescents. At that point, the FDA asked that manufacturers include in the warning that all children and teenagers be closely observed and monitored while taking the drugs. Furthermore, SSRI drug companies were asked to develop medication guides-FDA-approved in-formation packs for patients and their families to be handed out with each new prescription or refill. These guides were designed to be user-friendly and easily comprehensible by non-medical people, and to improve monitoring of symptoms.

However, after this latest bombshell, the FDA itself decided to examine whether adults also faced any similar risks. The agency began its own review of nearly 3000 antidepressant studies, which included more than 77,000 adults taking SSRIs. At the end of last year, the evidence was in. The studies showed that there were five additional suicides or suicidal impulses for every 1000 young adults studied. An earlier study showed that the drug causes14 additional cases of suicidal impulses per 1000 in those under 18. TheFDA's Psychopharmacologic Drugs Advisory Committee concluded that new labelling changes were necessary to inform healthcare professionals that young adults, as well as teenagers and children, also face suicide risk with these antidepressants.

This new information about SSRIs calls for a drastic revision of the useof SSRIs. Patients should only be given these drugs for, at most, two weeks. Thereafter, doctors are needlessly exposing their patients to an increased risk of drug-induced self-inflicted death.

The FDA is quick to add that the scientific data to date does not showan increased risk of suicide among those aged over 24. Indeed, it appears that adults over 65 taking antidepress-ants decrease their risk of suicide-a benefit that will be highlighted in the new black-box warnings.

One can only guess whether this last bit of received wisdom will also be undermined by evidence unearthed at a later date.

Lynne McTaggart

Diabetes drug

Death by aspirin

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