Off-label prescribing for children in Europe.


Off-label, unauthorised Rxing (prescribing) in children “widespread” in Europe

Lynne Taylor  World News | January 27, 2011


“The prescribing of off-label and unauthorised medicines to children is still widespread in Europe, accounting for 45%-60% of total prescriptions in both inpatient and outpatient care, says a new report from the European Medicines Agency (EMA).”

This article goes further to say that the study notes that the therapeutic classes that are used most frequently off-label or without a marketing authorisation are among others.. contraceptives, antibiotics and ssri anti-depressants. 

There are reasons why ssri’s are not licenced for children. (The warnings have been upped to age 25 buts that’s another story) The E.U. has published these warnings/side effects for under 18’s taking ssri’s..

Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility. 




It’s not just Americans who have to deal with the fall-out from off label prescribing, the side effects are the same for european children. But is it just American pharmaceutical companies that are fined for improper conduct?


 Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Why: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a $313 million penalty.  The settlement also covered Forest’s off-label use of Celexa for children’s use.

With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy. 
Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why:  J&J received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (GSK) was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.
With: Department of Justice
When: Jan. 26, 2009
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.

With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.





 January 2009
 European UnionDrug Class: Newer Antidepressants, Older AntidepressantsAge: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide
Summary: The Pharmacovigilance Working Party (a party that provides advice on the safety of medicinal products and on the investigation of adverse reactions associated with medicinal products authorized in the European Union) recommended an update to product labeling and all antidepressants patient information leaflets to include information on the increased risk of suicide for children to young adults.
Source: “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, January 2006.
August 19, 2005
European UnionDrug Class: Newer AntidepressantsDrug Name: Fluoxetine, Fluvoxamine, Sertraline, Paroxetine, Citalopram, Escitalopram, Atomoxetine, Duloxetine, Venlafaxine, Mianserin, Milnacipram, Reboxetine, Mirtazapine
Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility
Summary: The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child antidepressant use as recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP).
Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.
Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.


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