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fema4psychiatrists

UK Drug Regulator Sends Out PSSD Letter (TAKE ACTION)

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fema4psychiatrists   
fema4psychiatrists

"Dear Mr (removed),

Yellow Card Registration Number: (removed)

Thank you for sending us a suspected Adverse Drug Reaction (ADR) report.

It would be helpful if you could provide us with some additional details if they are available by email (yellow.card@mhra.gsi.gov.uk or by letter (Freepost Yellow Card). Please quote the above reference number with all correspondence.

We appreciate that you may have submitted this report some time ago but by way of background, I should explain that we are currently investigating all Yellow Card (YC) reports where sexual dysfunction has been reported in association with a type of antidepressant drug called Selective Serotonin Reuptake Inhibitors (SSRIs).

This issue remains under close surveillance and we are keen to gather as much information as we can about each reported incident. In particular it would be useful if you could provide the following additional information to shed further light on this issue:

- Have you recovered from sexual dysfunction or is it still continuing?
- If you recovered could you indicate whether it stopped before, on stopping or after the Sertraline was stopped. If you remember please provide the date on which the reaction stopped or roughly indicate how long it took for you to recover?
- If you have not recovered yet but do in the future could you inform us so that our records are up to date?
- Do you have any previous history of sexual dysfunction?

If you are worried about the suspected side effect, and need medical advice, please contact a doctor or pharmacist, or call the NHS 111 service.

Your contribution to the UK’s Adverse Drug Reaction Reporting Scheme is greatly appreciated. This provides an important early warning of previously unrecognised adverse effects which allows us to take appropriate action to improve the safe use of medicines.

Yours sincerely

(removed name)
Vigilance and Risk Management of Medicines"


If you Haven't reported continual sexual adverse harms NOW is the time to do it!

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nz11   
nz11

Are you saying a pssd letter is being sent out to everyone filing a yellow card or just you?

If it is a standard letter to all do you have a link to a website that is going public with this ?

I find the 'please contact your doctor' to be useless advice. It will just result in a dismissive unacknowledged response.

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fema4psychiatrists   
fema4psychiatrists

I believe it has been emailed to everybody that has reported antidepressant sexual dysfunction.

 

"We appreciate that you may have submitted this report some time ago but by way of background, I should explain that we are currently investigating all Yellow Card (YC) reports where sexual dysfunction has been reported in association with a type of antidepressant drug called Selective Serotonin Reuptake Inhibitors (SSRIs).

 

This issue remains under close surveillance and we are keen to gather as much information as we can about each reported incident. In particular it would be useful if you could provide the following additional information to shed further light on this issue:

- Have you recovered from sexual dysfunction or is it still continuing?"

 

We need to respond in numbers, this is a chance for recognition that PSSD actually exists. I believe this step is often the pre-cursor to dodgy drugs being removed from the market. Either way we should not pass up the opportunity to respond in the right numbers.

 

They simply want an simple email response to the 4 questions. one of them being is the sexual dysfunction still continuing. 

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nz11   
nz11

Well hopefully the sleeping giant regulator is now waking up.

 

Are you able to advise of the date of the email.

 

I might bring this to the attention of a few down this way.

 

I wonder when this 'currently investigating' began?

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fema4psychiatrists   
fema4psychiatrists

Well hopefully the sleeping giant regulator is now waking up.

 

Are you able to advise of the date of the email.

 

I might bring this to the attention of a few down this way.

 

I wonder when this 'currently investigating' began?

It was sent on February the 23rd by 

Julia Cowen

Vigilance and Risk Management of Medicines

 

Feb 23 (2 days ago)

 

 

 

Yes it is a very late "early warning system". 68 odd million people on antidepressants 30 years later

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nz11   
nz11

fem i assume that you were on sertraline right? You havent put it in your drug sig that could be helpful.

 

Just posted a copy of this standard letter to our nations centre for adverse reactions management. 

 

thanks for the info.

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