May 2009
The following warning has been issued by the USA Federal Drug Administration and is legally relevant to the United States only.
(Many of these Medications are in use in Australia and we have provided the information here as a matter of interest.)
FDA Warning: Update 5/5/2009
Suicidal Behavior and Ideation and Antiepileptic Drugs
AED (Antiepileptic Drugs) class label changes
Manufacturers of antiepileptic drugs (AEDs) or anticonvulsant drugs will update product labeling to include a warning about an increased risk of suicidal thoughts or actions and will develop a Medication Guide to help patients understand this risk. These changes affect all approved AEDs except those indicated only for short-term use.
Drugs with updated labels:
The approved AEDs affected by these safety label changes are:
Carbatrol
Celontin
Depakene
Depakote ER, Depakote sprinkles, Depakote tablets
Dilantin
Equetro
Felbatol
Gabitril
Keppra
Keppra XR
Klonopin
Lamictal
Lyrica
Mysoline
Neurontin
Peganone
Stavzor
Tegretol, Tegretol XR
Topamax
Tranxene
Tridione
Trileptal
Zarontin
Zonegran
and generics.
FDA approved updated labeling for these drugs on April 23, 2009.
Drugs with Medication Guides
New comprehensive Medication Guides were approved on April 23, 2009, for Lamictal, Lyrica, Topamax, Zonegran and Keppra. Comprehensive Medication Guides are being developed for the other drugs and should be available by the end of 2009.
Background:
Since issuing safety alerts on December 16, 2008 and January 31, 2008 (see below), FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk.
As described in the January 31, 2008, Information for Health Care Professionals Sheet on AEDS, eleven antiepileptic drugs were included in FDA’s original pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions.
The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.
Further detailed information is accessible to the public on the FDA website. A link to the FDA Home page is located on our 'Helpful Links' page.
25 January 2009
The Melbourne Herald Sun newspaper reported Medicare Statistics recording the treatment in Australia of 55 children 4 years of age and under with Electroconvulsive Therapy (ECT). A total of 203 ECT treatments have been given to children under 14 years of age.
The article cites a VicHealth report confirming more than 18,000 ECT treatments were conducted in Victoria in 2007-2008. Of these one third or 6197 ECT treatments were given to people against their will.
A total of 12,000 or two thirds of the 18,000 treatments conducted in Victoria were performed in the Public System.
The report did not state if the 6,197 involuntary treatments were conducted in the Public or Private sectors or both.
If the involuntary treatments were undertaken in the Public Sector this would represents over half of total treatments delivered in that sector.
Federal Government statistics quoted show that the use of ECT in the Private Health System increased from 1944 treatments in 2001-2002 to 6009 in 2007-2008.
It was also reported that the Western Australian Government is moving to ban ECT treatment of children under 12 years of age. It is not known if other State Governments will follow.
21 January 2009
Victoria - State Opposition slams under-resourced mental health facilities in the Gippsland Region citing an in-patient return rate of 15% due to premature release and lack of satisfactory servicing post release.
Admission waiting times are also the subject of focus with many patients waiting too long in Accident and Emergency before admission.
Latrobe Regional Hospital's mental health unit is currently operating in excess of 100% occupancy.
11 January 2009
A report in the Melbourne Herald Sun newspaper of a 16 year old high achieving student with no prior mental health issues winning a substantial payout for Antidepressant induced psychosis which she suffered after being prescribed a cocktail of medications for period pain in September 2006.
The report stated that while on medication she attempted suicide four times, threatened her mother with a knife and was committed to the adolescent psychiatric ward at the Royal Childrens Hospital. In the hospital she was given Prozac and sleeping pills and her condition deteriorated further.
Her mother who later removed the girl from hospital (when she started turning yellow), stated that within days of stopping the treatment her daughter returned to normal.