MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

SSRi problem?

What problem?

One would think that the British drug regulatory agency, the MHRA, would eventually admit there was a problem with SSRi's, so much of a problem that the risks of prescribing them outweigh the potential benefits of taking them.

Now, after years of being bombarded with yellow cards, anecdotal reports and meetings with SSRi patient advocates, they have decided to offer advice to clinical practitioners in the form of an "SSRi Learning Module."

Fantastic, superb, about bloody time, may be some of the terms used upon hearing this news. I agree that is a step in the right direction but, through experience liaising with the MHRA in the past, I see it as a mere 'cover our ass' type of module. The MHRA want to be seen to be doing something about the SSRi problem yet the module offers nothing that isn't already on the patient information leaflets that accompany this family of medicines.

I have to admit that browsing through the module had me shaking my head in disbelief, it's more of an industry stance than one that is impartial and protecting the consumers. It offers nothing new to clinical practitioners and appears to be yet another buck-passing operation that shows the MHRA admit there is a problem but they really do not know how to handle it.

I'd like to know where they gained their information from, particularly the section entitled "Principal Risks."

Before I dissect what I believe to be a token gesture to all those suffering SSRi withdrawal problems, I'd like to ask why this Learning Module is flying under the radar, why hasn't this been announced to the mainstream press by MHRA CEO Kent Woods? One can only assume that the MHRA don't want people like me shouting from the rooftops, "I told you so". Assumptions is all people like me are left with when a body of regulators are less than transparent.


SSRI learning module: Principal risks


The MHRA module states:

Some noteworthy risks for SSRIs are discussed in this module. Summaries of product characteristics and the BNF should be consulted for a fuller account of the risks of individual SSRIs.

The BNF is close to my heart. On 2 September 2008 I pointed out to Kent Woods that the advice given for SSRi withdrawal in the BNF was minimal. Kent, without making any promises [cover your ass stance] told me that the MHRA would approach the BNF to see if the advice could be changed. In the same meeting I also urged Kent Woods to seek the advice of an expert on SSRi withdrawal. I put forward the name of Professor David Healy. A year or so later, 26 June 2009, MHRA officials met with Healy in a meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants.

To my knowledge the BNF gives no sound advice on SSRi withdrawal, three years after I asked for it. Healy's withdrawal protocol he offered the MHRA over two years ago remains on the table collecting cobwebs no doubt.

Back to the module.

Two items of note on page 1 of the 18 page module:


Pregnancy and breast-feeding:
The decision to prescribe an antidepressant during pregnancy involves very careful assessment of risks to the mother and fetus of untreated depression during the pregnancy and the risks to the fetus of adverse effects including teratogenic [1] effects from exposure to an antidepressant.

and

Overdose:
Features of overdose include the usual adverse effects of SSRIs, but very large overdoses can also lead to cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma. SSRI overdosage is managed by treating specific symptoms as they arise.

It appears that the MHRA are clearly stating here that SSRi's are teratogenic. Bravo. The penny has finally dropped.

In my book, The evidence, however, is clear...the Seroxat scandal, I dedicate a chapter to my correspondence with the MHRA when I wrote them and asked a specific question, 'Is Seroxat a teratogen?' The response I got was limp-wristed at best and about as clear as mud. It took the MHRA over three weeks to give me an answer that was basically them fence-sitting.


Dear Mr Fiddaman, 


The question “Is paroxetine a teratogen?” is not as straightforward as it may appear, set the tone for what must have caused a severe case of splinters on the ass for whoever drafted it. No doubt it was run by lawyers first...and probably GlaxoSmithKline too, whom I had also contacted with the same question, their response was about as useful as an inflatable dartboard in as much that they told me to "talk to my doctor."

On overdosing, the module now admits that a large overdose may cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma.

Here's what the MHRA wrote in 2008 [2]:

Selective Serotonin Re-uptake Inhibitors (SSRIs) are a class of medicines that have been used in the treatment of depressive illness and anxiety disorders since the late 1980s. The general adoption of SSRIs into clinical practice reflected in particular their greater safety in overdose, an important advantage in comparison with risks associated with the previous generation of antidepressants, known as tricyclic antidepressants.

Ho hum, what a difference almost 4 years make.

I'm probably being pedantic here, they never actually said that SSRi overdoses didn't cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma back in 2008 - at least that's probably the argument they'd use in their defence today. It appears that one has to ask these questions before the MHRA answer them, they don't think it important enough to tell you first and, hey, if you don't ask then that kinda leaves them in the clear.

Page two of the module leads with...

SSRI learning module: Gastrointestinal adverse effects.


The module goes on to say that "Gastrointestinal side effects increase with the dose. Drugs that raise the concentration of SSRIs (eg cimetidine with citalopram, escitalopram or sertraline) may increase the risk of side effects. There is no specific treatment for gastrointestinal adverse effects of SSRIs. If unwanted effects do not subside over time and continue to be troublesome then dose reduction can be considered; alternatively, the antidepressant could be changed."


In other words, we don't really know so we suggest doctor's reduce or change the antidepressant. And this is a 'learning module'? Exactly what are clinical practitioners learning from this advice?

Page three moves on to:

SSRI learning module: Central nervous system adverse effects.


Here they mention the more 'common' side-effects, I beg to differ. The ones they list as being rare seem to be more prominent these days.

I'm finishing off Part I of this blog post with section 4 of the module;

SSRI learning module: Psychiatric adverse effects.


This is head-shaking stuff, yet more of 'we don't know what to suggest so we'll just put the patient on a carousel until we can figure out how to combat this problem.

They write:

SSRIs can produce an uncomfortable mental sensation of tension, restlessness or anxiety (akathisia—feeling of restlessness and inability to sit or stand still). This paradoxical state of anxiety can occur when initiating treatment. Severe agitation, psychotic symptoms and suicidal ideation are rare but these serious symptoms must be recognised and addressed.

As far as treating the above symptoms, the MHRA offer this advice:

Anxiety symptoms often settle within a few days of treatment. Regular review and reassurance of the patient may be all that is required. If anxiety symptoms do not abate, the dose of SSRI may have to be reduced. For severe and distressing symptoms use of a benzodiazepine early in the treatment may be considered but, to reduce the risk of benzodiazepine dependence, the duration of such treatment should not exceed two weeks. If symptoms persist, an alternative treatment should be considered.

What alternative treatment? Chicken in a basket, fried eggs on toast, jogging on the spot perhaps? It's all well and good offering advice to doctors but when that advice is so blatently vague it just leaves the doctor's who, like all human beings, have differing opinions on matters. If the MHRA are going to go to great lengths of an SSRi Learning module then for the love of God don't be half-arsed about it. Don't leave the doctor to make his own decision because you just don't know?

In truth, the MHRA are burying their heads in the sand. The 'alternative' treatment is not mentioned here because they don't know what the alternative treatment is - they are putting the onus on the doctor to make that call which, in my opinion, is basically a Carte Blanche for more prescription scribbling for more medication that the patient does not need. A blank cheque, if you will.

Judging by the advice given to doctors by the MHRA on patients suffering psychiatric adverse events it would appear that they are shrugging their shoulders and muttering, "Um...we dunno." They are merely disguising that 'advice' as "alternative."

If clinical practitioners are going to be re-educated on the dangers of SSRi's, the last people I'd want teaching them would be an agency wholly funded by the pharmaceutical industry. - Bob Fiddaman


Part II coming soon.






[1] Teratogenic: Able to disturb the growth and development of an embryo or foetus
 Teratogen: Any agent that can disturb the development of an embryo or foetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs

[2] MHRA Investigation into Glaxosmithkline/Seroxat


Fid 


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