Canada

FDA warns against Paxil for teens and kids

No one under the age 18 should be using Paxil for depression because the adult antidepressant may increase their risk of suicide

U.S. regulators warned consumers Friday that no one under the age of 18 should be using the drug Paxil for depression because the antidepressant designed for adults may increase their risk of suicide.

The Food and Drug Administration's warning came a week after the British government banned prescribing the drugs to anyone under the age of 18.

The FDA had asked all makers of adult antidepressants to submit research on how their drugs affect children.

Paxil's manufacturer, GlaxoSmithKline's studies found that their drug did not seem to help pediatric depression.

However, the FDA noticed some safety concerns and ordered GlaxoSmithKline to analyse the data again.

The latest analysis found the risk of suicidal thoughts and suicide attempts to be three times greater among Paxil users, mostly teens, than among children given dummy pills, according to the FDA.

The FDA said youth using Paxil should not suddenly stop using it. Rather they need to ease off the drug under medical supervision.

Paxil is approved in Canada and the United States for adult treatment of a number of psychiatric illnesses including depression. 

Both Health Canada and the FDA have never approved of the drug for people 18-years-old and younger. But some doctors prescribe the drug anyway.

In Canada, Paxil or Paroxetene is the eighth most commonly prescribed drug, according to IMS Health statistics. In 2000, more than three million prescriptions were filled for Paxil.

Paxil has been the subject of several class-action suits in both countries. Plaintiffs argued that they suffered from dependency and withdrawal reactions. 

Paxil is listed as an SSRI drug - selective seratonin re-uptake inhibitor - which means it is not supposed to be addictive. Other SSRI drugs are Prozac and Zoloft.

GlaxoSmithKline changed its labelling early last year, making it clear some patients will suffer serious effects if they're taken off the drug too quickly.

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