Six months after the UK banned antidepressant drugs for children, Health Canada has issued a warning that using 7 of the medications may make patients worse.

Patients of all ages taking fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), mirtazapine (Remeron), fluoxetine (Prozac) and citalopram (Celexa), as well as those taking bupropion as an antidepressant (Wellbutrin) or smoking cessation drug (Zyban) may “experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others,” Health Canada cautioned June 4 in a directive to physicians and consumers.

Recent studies have indicated that selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenalin reuptake inhibitors (SNRIs) may worsen depression or trigger suicidal or aggressive impulses.

In December 2003, the UK banned the use of 4 antidepressants for children; it had banned 2 others earlier last year. The US Food and Drug Administration followed on March 22 with a strongly worded warning about the drugs.

But the chair of a 5-member expert advisory panel Health Canada convened to assess SSRIs does not believe the evidence supports a British-style ban or a stronger warning, he says. The more “measured” Canadian response puts the issue in proper perspective for physicians, says Dr. Yvon Lapierre. “There is some evidence that maybe this is happening, sufficient to give you this warning, but not to remove it from the market.”

Manufacturers will be required to amend their product monographs, patients will be notified through an information sheet accompanying their prescriptions, and physicians will receive letters informing them of the risk, says Health Canada spokesperson Jirina Vlk.

Patients who experience suicidal impulses or feelings of agitation, hostility or anxiety are urged to consult their doctor rather than discontinuing the medication abruptly, which may provoke serious withdrawal symptoms.

“The Americans have taken the same attitude as we have in Canada: be careful,” says Lapierre. “Treat your patients properly. Keep an eye on them and you shouldn't have any problems.”

An article by Lapierre (J Psychiatry Neurosci 2003;28[5]:340-7) concluded there is little evidence that SSRIs cause increased suicidality.

The delay in Health Canada's response to concerns about the drugs was necessary, says Vlk, because reviewers examined more than 70 brand-name and generic versions of the medications licensed in Canada. — Wayne Kondro, Ottawa

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