|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0) 207 586 7771|
|[email protected] http://www.socialaudit.org.uk|
|Dr June Raine, Director|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
11 December 2002
"Electric head" symptoms during attempted withdrawal from SSRI etc antidepressants
I have attached to this letter a small sample of the descriptions users have given of a widely-reported phenomenon classically linked to withdrawal from paroxetine and other SSRIs and often referred to by users as in terms such as, "electric head," "zaps," "head shocks", or "brain shivers." Many email reports from visitors to the Social Audit website have suggested: [a] that this is one of the main underlying causes of the unsteadiness, dizziness and nausea commonly experienced in attempted withdrawal, and [b] that they have found it very difficult to describe this phenomenon to doctors and/or that the doctors response conveys that they have failed to convince him/her that this is a symptom of drug withdrawal. However, the same phenomenon has been reported from time to time in case reports, published since 1993:
"Two days after beginning this later phase (withdrawal under double-blind conditions) she began to experience the same tightness in her chest, nightmares and "a slamming against her head" which she later described, "even though it sounds silly [as] like electricity." A week later she paged us over a weekend in tears, complaining of the intensification of these symptoms as well as having cold hands, night sweats and intermittent nausea. These symptoms continued for several more days, until at two weeks after beginning the randomised withdrawal phase, the symptoms remitted" (G. Mallya, K. White, C. Gunderson, Is there a serotonergic withdrawal syndrome? Biol Psychiatry 1993 Jun 1-15, 33 (11-12), 851-2.)
"I have observed a peculiar and distinctive withdrawal phenomenon in approximately 5% of the patients I have treated with SSRIs. This withdrawal buzz is described as a distractingly intense sensation within the head lasting 1 to 2 seconds. Patients have likened it to a jolt, a rush, a shock, or a brief moment of disorientation and dizziness." (J.M. Ellison, SSRI withdrawal buzz (letter). J Clin Psychiatry, 1994, 55, 544-545.)
"On July 23 (1994), a communicant accessing the Internet from the California Institute of Technology confided that he had experienced, after abruptly discontinuing fluoxetine, random flashes of split-second dizziness or vertigo, which feels like a mild electric jolt in your brain, like a pin-prick instant of disorientation." (Anon, Currents in Affective Illness, 1994, 13, 11, 15-17)
Reports from both users and professionals underline that these symptoms are not only disabling and distressing, but have also sometimes prompted complex investigations (MRI, CT and EEG scans) and/or treatment for other conditions including viral infections, influenza, inner ear infections, vertigo, allergy to other drugs, brain tumour, meningitis and serious mental illness. Again, the documentation on this goes back some way: "We were particularly impressed by the complaint of dizziness or incoordination. Several subjects believed that they had contracted a viral illness and sought medical attention; two were told by their physicians that they had an inner ear infection and were prescribed medication."(D.W. Black, R. Wesner, J. Gabel., The abrupt discontinuation of fluvoxamine in patients with panic disorder. J Clin Psychiatry 1993 Apr, 54 (4), 146-9).
Against this background, I am now writing to ask:
1. How this phenomenon is presently coded in the ADROIT system whether simply as "drug withdrawal reaction" or under some other approved term?
2. Please would you supply us with a copy of any document (or extracts thereof) giving advice on coding or classification to those responsible for entering Yellow Card, data specifically relating to SSRI etc withdrawal reactions, on to the ADROIT database?
3. In the MCA/CSM statement on SSRIs in Current Problems in Pharmacovigilance (September 2000, 12), it is stated: "there have been isolated reports of more serious symptoms on withdrawal such as severe electric shock sensations " Please could you explain the basis on which this assessment of magnitude ("isolated") was made, indicating also the numbers of reports received that were considered "severe" or not?
4. There is no reference to electric shock sensations in either the Seroxat SPC (which warns of "dizziness, sensory disturbance ...and confusion following abrupt withdrawal"); nor in the Patient Information Leaflet (which refers to "tingling sensations."). Please could you explain why not, and whether the MCA/CSM has ever proposed to companies holding licenses for SSRI and related antidepressants that this characteristic of withdrawal should be referred to in product warnings?
5. Please could you say whether the MCA/CSM have made or will now undertake some assessment of the neurological implications and clinical significance of this electric head phenomenon? If any assessment has been done, please would you indicate what enquiries were made (e.g. to companies holding licenses for SSRI and related antidepressants) and what if any conclusions have been drawn?
Please treat these as formal requests under the relevant Code of Practice. Thank you for your attention. I look forward to hearing from you.
SSRI USER REPORTS OF ELECTRIC HEAD EXPERIENCED DURING ATTEMPTED WITHDRAWAL
"Twenty four hours after the last dose I begin to feel extremely strange reactions in my brain, which have proved extremely hard to describe to the GP. A slew of weird sensations in my brain gather pace as time wears on. It feels like little electric misfirings going off in there which resulting in a feeling of disorientation. It's almost like the brain is having its version of goose pimples! It took me ages to figure out that this feeling was the result of not taking the pill. It was and is hard to get across to the doc that these strange feelings are not because of taking the pill but the lack of it." (Ref: 006)
"THE WORST SYMPTOM - I call this `electric head'. A rapid succession of pulses which are very disorientating and distracting. The pulses are accompanied by a sound best described as the crack heard when a golf ball is hit off the tee. `Electric head' can occur at any time but I have found it is very much accentuated during exercise and when turning my head quickly to one side. It is a very unpleasant experience, I have experienced such powerful pulses that I have grimaced as if in pain." (Ref: 008)
"I too am experiencing the electric head. What an appropriate name. Mr doctor told be that it was simply my anxiety returning. I explained that my eyes felt jumpy when I looked from side to side, but he still attributed it to returning anxiety. Its good to see others having the same symptoms, so I know Im not imagining things!" (Ref: 0026)
"On the 7th day (of withdrawal) I noticed that the electric explosions in my head were triggered off by the movements from left to right of my eyes. Up and down gives no shocks neither does moving my head from left to right while keeping my eyes still." (Ref: 0032)
"I experienced those 'electric shocks' but was never able to describe exactly what they were. It was as though my brain stopped for a split second and then started up again My 'electric shocks' probably lasted about 3 weeks." (Ref: 0057)
"I keep getting the strange little head rushes that are quite disorienting, my head feels tight and if I move my head or my eyes quickly I get a strange feeling in my head as if there's an electric current being discharged into my brain. This last one is accompanied by a strange sound similar to two lightsabers hitting each other (as in Star Wars), often a few zaps in a row. It's like having Darth Vader and Luke Skywalker battling it out behind my eyeballs." (Ref: 0104)
"When I would turn my head, it would seem that my brain would follow moments later and send me into a spin. It was the most devastating symptom of withdrawing from that horrid drug." (Ref: 0115)
"I can't get off them. Every time I try I end up on the couch. My head is full of sea and when I try to stand up, I topple over. If I look to the right I drag the whole world with me and there's a kind of comet-tail in its wake...am I going mad?" (Ref: 02564)
"My head is constantly pressurized and dizzy. When I turn suddenly to look in a direction, I have to be careful that my head doesn't fall off...It feels like it is filled with water like a bucket balanced on a stick. I keep feeling like I have something wrong with my brain or my eyes..." (Ref: 0193)
"I too am experiencing the electric head. What an appropriate name. My Dr. told me that it was simply my anxiety returning. I explained that my eyes felt jumpy when I looked from side to side, but he still attributed it to returning anxiety. It's good to see others having the same symptoms, so I know I'm not imagining things!" (Ref: 0026)
"My doctor told me there is no particular way to come off them and he told me to come off of them at my own discretion. I was going on holiday in two weeks time to celebrate finishing my exams, so decided to try and come off them in time so that I could drink. Unfortunately in the second week I felt this slight twinge in my head when I moved from side to side. This only happened once or twice in an evening so I didnt worry about it. Nothing really happened again for about 4 days when I started getting the feeling more frequently. It's like an electric zap gets fired off in my brain which makes everything feel very unstable. To start off with this was okay - however yesterday I was having to lean against a wall to steady myself and today I can barely stand up. I decided that I would look into it and see if anyone else had experienced these symptoms and "hey presto" there you all are." (Ref: 0021)
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