Other safety alerts
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| Canada: ADHD drugs may increase risk of suicidal thoughts and behaviours in some people; benefits still outweigh risks |
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Stronger, clearer warnings on the risk of suicidal thoughts and behaviours are being incorporated into the prescribing information for drugs used in the management of Attention Deficit Hyperactivity Disorder (ADHD).
The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs. The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.
There are different types of ADHD drugs and the evidence varies with respect to the risk of suicidal thoughts and behaviours. This risk is already known for one ADHD drug, Strattera (atomoxetine), and was incorporated into its prescribing information and communicated in 2005.
New information has emerged since to suggest that the risk of suicidal thoughts and behaviours may apply to all other ADHD drugs. There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk. It is important to note that people with ADHD may already have a slightly increased risk of suicidal thoughts and behaviours. ADHD may also affect people who have other mental health conditions that are associated with an increased risk of suicide, such as depression or bipolar disorder.
The prescribing information for all ADHD drugs is being revised to include standardized warnings that better reflect the available evidence on the risk of suicidal thoughts and behaviours, except the monograph for Strattera which already includes detailed safety information on this risk. ADHD drugs are available by prescription only and are authorized for use in adults and children over the age of six years. There are several brand name and generic drugs available in Canada: ADDERALL XR (mixed salts amphetamine extended-release), BIPHENTIN (methylphenidate controlled release), CONCERTA (methylphenidate extended release), DEXEDRINE (dextroamphetamine sulfate), INTUNIV XR (guanfacine extended release), RITALIN (methylphenidate), RITALIN SR (methylphenidate extended release), STRATTERA (atomoxetine) and VYVANSE (lisdexamfetamine dimesylate).
It is Health Canada's view that the benefits of these drugs in the effective management of ADHD continue to outweigh their risks. The possible occurrence of psychiatric side effects with ADHD drugs is included in the prescribing information (product monographs) in a warning section that emphasizes the importance of monitoring moods, behaviours, thoughts and feelings in adults and children taking these medications, and the importance of taking psychiatric disorders into account when prescribing these drugs.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../52759a-eng.php
In Hong Kong, among the ingredients listed by the Health Canada, there are 19 and 11 registered pharmaceutical products containing atomoxetine and methylphenidate respectively, and they are prescription-only medicines. There are no registered pharmaceutical products containing mixed salts amphetamine, dextroamphetamine sulfate, guanfacine and lisdexamfetamine dimesylate. So far, the Department of Health has not received any adverse drug reaction report on the drugs. In view of the Health Canada's announcement, a letter to healthcare professionals will be issued on the new warning, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, March 31, 2015
Issued at HKT 16:00
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