| Article: | Seroxat use to be restricted by DOH | |
| Date created/last modified: | 10th June, 2003 | |
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| Article: | Seroxat use to be restricted by DOH | |
| Date created/last modified: | 10th June, 2003 | |
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An announcement is expected today from The Department of Health about new curbs on use of the antidepressant drug Seroxat. This is in response to claims that it has pushed some people to suicide and caused withdrawal problems in others. The latest changes are expected to relate to the use of the drugs in under 18s, rather than in all patients. Although the drug is not approved for use in that age group, doctors can prescribe it "off label", if they think it is appropriate for that patient.
The Medicines and Healthcare Regulatory Agency is concerned that Seroxat may trigger suicidal tendencies and other serious side effects in people under 18. It is expected to tell doctors that the drug should be given only to adults until further trials have been carried out on its side effects.
There have been several strongly contested legal cases in the US against makers of SSRIs after suicides among those taking the drugs over a couple of weeks, or even days, and in March, a coroner in Wales said that Seroxat should be withdrawn while its safety is investigated.
The move comes after reports that GlaxoSmithKline, the makers of what is Britain's most widely prescribed antidepressant, withheld nine studies showing that it could provoke suicidal tendencies and other symptoms in people under 18 years of age.
Campaigners want the claim it is not addictive to be removed from the information given out to patients with the drug and for the risk of violence to be acknowledged.
GlaxoSmithKline insists that the drug is safe, saying its experience with Seroxat involves thousands of physicians, millions of patients and over 10 years of experience worldwide. It states that there is no valid scientific research showing that Seroxat causes suicidal thoughts or acts. David Mawdsley from GlaxoSmithKline said "We can confirm that we have been in discussions with the regulatory authorities in the UK regarding updates to Seroxat labelling. "We would reiterate that Seroxat is an important medication in the treatment of depression and anxiety disorders."
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