Paxil - Seroxat News

Across the world, health organizations are watching closely the developments in the United Kingdom. On June 10, 2003, the Medicines and Healthcare Products Regulatory Agency (MHRA) stated the U.S. FDA is now evaluating Paxil - Seroxat regarding the medication side effect of, suicide and self harm.

The claim is only for children of 18 years and younger at this time. 

This is not new news to many of you that have tried to quit taking Paxil or to even use the medication. The side effects are some of the worst and the withdrawal is staggering.

Links to news articles: (All open new browser windows)

June 2, 2004 
NY Attorney General Sues Glaxo on Paxil

NEW YORK (Reuters) - N.Y. state Attorney General Eliot Spitzer said on Wednesday he sued British pharmaceuticals group GlaxoSmithKline Plc, claiming fraud over its antidepressant drug Paxil.

*** July 15, 2003  "Canada has followed in the footsteps of the United States and Britain, instructing doctors and parents that children under 18 shouldn't take a popular anti-depressant because it appears to trigger suicidal thoughts in some adolescent users."

*****June 19, 2003 2.15 PM E.S.T. 
The U.S. Food and Drug Administration on Thursday warned that patients under age 18 should not take GlaxoSmithKline's antidepressant Paxil because of a possible increased risk of suicidal impulses associated with the drug.

*** Read the letters from GlaxoSmithKline regarding Paxil - Seroxat side effects and withdrawal.

"Young people advised not to use Seroxat

The anti-depressant Seroxat should not be used to treat youngsters under the age of 18, according to Government experts. However patients should seek medical advice before discontinuing use."

"UK says U.S. FDA evaluating data on GSK's Seroxat

LONDON, June 10 (Reuters) - Britain's drug regulatory agency said on Tuesday the U.S. Food and Drug Administration was evaluating data on GlaxoSmithKline Plc's <GSK.L> antidepressant Seroxat after the UK warned it should not be given to children."

"GSK faces fresh Seroxat woe
A GOVERNMENT agency is today expected to deliver a damning verdict on GlaxoSmithKline’s widely-criticised anti-depressant Seroxat.

The Medicines and Healthcare Products Regulatory Agency (MHRA) will outline new advice for patients and prescribers about Seroxat,"
"LONDON

By Vivienne Russell

The commonly prescribed antidepressant Seroxat (paroxetine) should not be used to treat children and teenagers under the age of 18, according to latest government guidance."

"Problem With GlaxoSmithKline Depression Drug

06/10/2003 07:51 AM EDT

British drug giant GlaxoSmithKline (GSK:NYSE -  conceded that its antidepressant Seroxat caused heightened suicidal thinking in some young patients, but urged that nobody stop using it before consulting with a doctor.

The statement follows a recommendation from the U.K. government that physicians stop prescribing the medication to people under 18. "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks," the government said."

"Prescribing advice on Seroxat for children and adolescents issued (REF: DH)

The Chief Medical Officer (CMO) has issued prescribing advice on paroxetine (Seroxat) following the publication of new evidence on the drug's safety and efficacy in children and adolescents under the age of 18 years. Paroxetine is not licensed for use in children but it is used in this age group outside the licensed indications."

"An advisory statement from the Department of Health says that their evaluation of new data on Seroxat shows:

"...that there is an increase in the rate of self harm and potentially suicidal behavior in this age group, when Seroxat is used for depressive illness. It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."

"Mother's plea over Seroxat - A Flintshire teacher who believes an anti-depressant drug triggered violence in her foster son said new guidelines outlining the dangers of taking Seroxat do not go far enough."

"Mood drug Seroxat banned for under-18s - The future of Britain's best-selling antidepressant drug, Seroxat, and the rest of the class which includes Prozac, was in question last night after drug regulators banned its use in under-18s."

"Britain Warns of Paxil's Risk to Children -
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, June 11, 2003; Page A14

The British government warned doctors yesterday against prescribing the antidepressant Paxil to children, spurring the U.S. Food and Drug Administration to confirm that it is conducting its own investigation into the safety of the drug for younger patients.

The British warning said the medicine appeared to increase the risk of suicide or suicidal thinking among children with depression.

The U.S. agency is examining the same studies that Paxil's manufacturer submitted to British authorities.

"There is data that has come to light that may be noteworthy," said an FDA official yesterday, speaking on the condition of anonymity. "We will take whatever action is deemed appropriate to protect the public health."

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