(1)   With reference to drugs used in the treatment of attention-deficit hyperactivity disorder (ADHD), can details be provided on the adverse effects reported to the Therapeutic Goods Administration for: (a) Ritalin; (b) Strattera; and (c) any other drugs used.

(2)   What is the status of the review of the federal guidelines for the treatment of ADHD.

(3) (a)   Who is conducting the review; and (b) do they have any connections with pharmaceutical companies; if so, what are they.

(4)   Will the review consider the recent recommendations of the United States of America Food and Drug Administration to put ‘black box warnings’ on these drugs, stating that the drugs can cause suicide, heart problems, stroke, hallucinations and high blood pressure.

(1)   As of 15 September 2006, the Therapeutic Goods Administration’s (TGA) Adverse Drug Reactions Unit has received the following reports of suspected adverse reactions to medicines indicated for the treatment of ADHD:

(a)   Methylphenidate (brand names include Ritalin) - 123 reports in total, the most commonly reported reactions being drug ineffective (11 reports), headache (10 reports), nausea, anorexia, somnolence, and depression (7 reports each).

(b)   Atomoxetine (brand name Strattera) - 23 reports in total, the most commonly reported reaction being aggression (4 reports).

(c)   Dexamphetamine - 60 reports in total, the most commonly reported reactions being agitation (7 reports), tachycardia (5 reports), hyperkinesia, hypertonia, and insomnia (4 reports each).

(2)   On 31 December 2005 the Attention Deficit Hyperactivity Disorder Guideline (1996) was rescinded in line with the National Health and Medical Research Council (NHMRC) policy that all publications be reviewed at least every five years to assess their continued currency and relevance. The updated guidelines are expected to be available by November 2007.

(3)  

(a)   The Department of Health and Ageing is funding the Royal Australasian College of Physicians to redevelop the NHMRC Guidelines on ADHD. The updated guidelines are expected to be available by November 2007.

(b)   I do not have the information to be able to comment on any connections between the Royal Australasian College of Physicians and pharmaceutical companies.

(4)   While a committee of the United States Food and Drug Administration (USFDA), the Drug Safety and Risk Management Committee recommended placing black box warnings on these medicines, the USFDA also sought advice from their Pediatric Advisory Committee on 22 March 2006. This committee is constituted to make recommendations about warning statements for these medicines. It recommended amendments to the warnings on the levelling documents, but not the addition of black box warnings. The USFDA is considering the advice of the committees. The TGA has recently completed a review of ADHD medicines and is in the process of strengthening existing warnings about cardiovascular and psychiatric adverse events in the Product Information (PI) document for health professionals and Consumer Medicine Information (CMI) document for patients. The advice of the Australian Drug Evaluation Committee (ADEC) was sought. Previously, on the advice of ADEC, there was a strengthening of the existing precautionary statements in the PI regarding suicidality and the inclusion of a black box warning relating to the issue of suicidality in children and adolescents treated with atomoxetine. A black box warning was added to the PI for atomoxetine by the TGA on 14 March 2006.