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.
The FOI Licensing Team
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)
|Benefits v Risk
It raises the level of the neurotransmitter,
serotonin, in the brain which can improve
symptoms of depression
Death and sudden death
Drug withdrawal syndrome
Immune system disorders
Exposure during breast feeding
Foetal exposure during pregnancy
Fractures and dislocations
Electrocardiogram QT prolonged
Heart rate increased
Abnormal liver function
Blood sodium decreased
Blood prolactin increase
Platelet count decrease
Blood creatine phosphokinase increase
Blood pressure increase
Blood pressure decrease
Muscle & tissue disorders
Nervous system disorders
Seizures and seizure disorders
Foetal growth complications
Confusion and disorientation
Emotional and mood disturbances
Fluctuating mood symptoms
Orgasmic disorders and disturbances
Nightmares and abnormal dreams
Loss of libido
Renal & urinary disorders
Reproductive & breast disorders
Classic Avoidance by the British Medicines Regulator, the MHRA
British Drug Regulator (MHRA) Dodging the Curve Ball