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.


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