Drugs

In this section, we publish a package insert concerning the warnings of a known psychiatric drug currently used for the pharmacological treatment of the syndrome of attention deficit hyperactivity disorder (so-called “ADHD”).

The publication of these documents does not imply an endorsement by our Scientific Committee of this or of other psychiatric drugs as an effective therapy for any childhood disease, nor in any way their recognition as effective solutions to the problems of inattention or excessive liveliness of children and adolescents. On the other hand, it does not mean censorship or condemnation of this specific drug solution or of the manufacturer of this or other products, neither in an absolute sense, nor as an underlying approval for alternative pharmacological or natural-based therapies.

The document is then released only to ensure complete consumer information.

We think it important to highlight to the reader the differences between the contents of the instruction manual for the general public and those intended for experts, since the latter contain information untold to the public. The differences between the two versions of the package insert are indeed significant. In bold the most relevant are highlighted, but a comparative analysis of the two documents in their entirety it is recommended. Among the omitted data from the version distributed to consumers, we note the fact that the mode of action of the drug on children have not been fully clarified, that no convincing evidence allows to demonstrate the relationship between the effects of the drug and the condition of the central nervous system, that the origin of behavioral disturbances of children is unknown and there are no diagnostic tests to verify it, that the degree of safety of the drug on young children was not established, that abuse may result in a marked habit and a psychological dependence with the emergence of abnormal behaviors; that, in case of interruption of the therapy, chronic depression and hyperactivity (which the drug should instead treat, Ed.) may occur again, that the safety and long-term efficacy are not known, that there are no clinical studies on the safety of use during pregnancy and it is not known whether this drug and its components pass into breast milk. The short version of the package insert – which accompanies the packaging for sale – does not include some of the side effects, such as – although rarely detected – hyperactivity, convulsions, muscle cramps, tics and Tourette’s syndrome (severe disabling tic, Ed.), toxic psychosis sometimes accompanied by visual and tactile hallucinations, depression, cerebral arthritis (inflammation of the cerebral arterial wall, Ed.) and/or cerebral occlusion, neuroleptic malignant syndrome, impaired liver function, starting from the increase in transaminases up to hepatic coma, angina pectoris, skin rash, fever, alopecia (head), exfoliative dermatitis, erythema multiforme, anemia.

 

Documents in Italian

PROZAC(C) TECHNICAL DETAILS

Package inserts of drugs on the market (short)

Package inserts for experts (extended)

The annex to the Ministerial Decree with an inventory of key drugs, including Methylphenidate

Prozac technical details, recently approved for children ages 8 and up

Comparative table of the cost of some drugs requiring a prescription and their equivalent generic products

 

We also publish below the package inserts (in English) of other psychiatric drugs for children

Adderall  extended technical details

Adderall  technical details

Concerta extended technical details

Concerta technical details

Daytrana extended technical details

Daytrana technical details

Desoxin technical details

Dexedrina extended technical details

Dexedrina technical details

Focalin extended technical details

Focalin technical details

Methadate  extended technical details

Methadate technical details

Methilin extended technical details

Methilin technical details

Strattera extended technical details

Strattera technical details