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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, November 25, 2016

Prozac - Benefits Vs Risks - MHRA Correspondence





For a while now I've been at loggerheads with the British drug regulator, the MHRA.  (Back stories below)

I've been asking them to send me a detailed list of the benefits of taking Prozac - Yesterday they sent me the following. My response to them follows...

Dear Mr Fiddaman

Apologies for the delay in responding.

Regarding your below enquiry, benefits are considered to be the therapeutic effects of the product to improve the medical conditions for which a product licence has been granted.  These are set out as the Therapeutic Indications in the Summary of Product Characteristics (SmPC) and in the uses of the product in the Patient Information Leaflet (PIL).  To further understand these benefits, you have asked what positive thing is going to happen to alleviate your depression.  The way in which the therapeutic effects are achieved is also explained in these documents.  In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression (and the other indications listed).  The MHRA does not promote medicines, but agrees in the SmPC  a factual summary of the effects of taking a particular medicine based on the results of clinical and non-clinical studies. 

I hope this answers your question.

Best regards

The FOI Licensing Team

--

My response...

Thank you for this.

So, in essence you are telling me that,  "In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression." is the one benefit and that this one benefit has been measured against the risks and the MHRA have granted Prozac a licence because they see that this one benefit outweighs the following reported risks with Prozac use...

Please try and help me (and others) understand how one benefit of a product outweighs the following risks associated with Prozac use.

All risks taken from the MHRA fluoxetine Drug Analysis Print  (DAP)
(http://www.mhra.gov.uk/home/groups/public/documents/sentineldocuments/dap_19529665880175380.pdf)


Benefits v Risk
Prozac Use.
Benefits

It raises the level of the neurotransmitter,
serotonin, in the brain which can improve
symptoms of depression
Risks

Blood disorders
Cardiac disorders
Congenital disorders
Ear disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Asthenic conditions
Death and sudden death
Febrile disorders
Feeling abnormal
Feeling jittery
Fibrosis
Gait disturbance
Peripheral swelling
Face oedema
Chest pain
Drug withdrawal syndrome
Hepatic disorders
Immune system disorders
Infections
Exposure during breast feeding
Foetal exposure during pregnancy
Fractures and dislocations
Electrocardiogram QT prolonged
Heart rate increased
Abnormal liver function
Blood sodium decreased
Weight decrease
Weight increase
Blood prolactin increase
Platelet count decrease
Haemoglobin decrease
Blood creatine phosphokinase increase
Blood pressure increase
Blood pressure decrease
Metabolic disorders
Muscle & tissue disorders
Neoplasms
Nervous system disorders
Seizures and seizure disorders
Tremors
Foetal growth complications
Ectopic pregnancy
Foetal death
Abnormal behaviour
Agitation
Anxiety
Nervousness
Aggression
Disinhibition
Homicidal ideation
Hostility
Paranoia
Personality change
Violence-related symptoms
Confusion and disorientation
Delusion
Depression
Depersonalisation/derealisation disorders
Insomnia
Eating disorders
Emotional and mood disturbances
Fluctuating mood symptoms
Impulsive behaviour
Restlessness
Mental disorders
Tearfulness
Apathy
Orgasmic disorders and disturbances
Panic attacks
Nightmares and abnormal dreams
Hallucinations
Personality disorders
Acute psychosis
Psychotic behaviour
Psychotic disorders
Schizophrenia
Libido decrease
Libido increase
Loss of libido
Sleep disorders
Dysphemia
Bruxism
Alcohol abuse
Akathisia
Completed suicide
Intentional self-injury
Suicidal ideation
Thinking abnormal
Tics
Renal & urinary disorders
Reproductive & breast disorders
Respiratory disorders
Skin disorders
Homicide completion
Vascular disorders




Bob Fiddaman.


Back stories

Classic Avoidance by the British Medicines Regulator, the MHRA

British Drug Regulator (MHRA) Dodging the Curve Ball








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