October 26

Guardian Reports: MHRA to Issue New SSRI Restrictions

Guardian Reports: MHRA to Issue New SSRI Restrictions

Mon, 14 Jun 2004

The Guardian reports that the British Committee on safety and Medicines, which was first to issue warnings about the potential suicidal risk for children prescribed an antidepressant of the SSRI class, are now about to issue similar warnings for use in adults:

“The Guardian understands that it has found a similar picture and that the drug regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA) is likely to impose restrictions on the use of some of them.”

However, in what may be a demonstration of the capricious nature of the drug approval process, the Guardian reports that the MHRA has asked Eli Lilly to submit Prozac (fluoxetine) data for approval in children.

When those who conduct the trials and those who review them are financially dependent (directly or indirectly) upon the drug industry, even evidence of drug-induced suicidal behavior, growth reduction, mania, and abnormal heart beats–in those who take the drugs–tend to be swept under the carpet.

Contact: Vera Hassner Sharav
Tel: 212-595-8974


UK – Safety alert on adult use of antidepressants Sarah Boseley, health editor Monday June 14, 2004 The Guardian

The modern antidepressant drugs which were thought to be a miracle cure for 20th century misery only 10 years ago are expected to suffer a second big blow this year when the UK authorities will warn that some of them can cause adults to become suicidal.

An expert working group of the government’s Committee on the Safety of Medicine (CSM) has already warned that all but one of the SSRIs (selective serotonin reuptake inhibitors), including the best-selling Seroxat, should not be given to children. It found that there were risks of children becoming suicidal, aggressive and suffering mood swings, and the drugs were anyway not very effective.

Now the committee is close to completing its review of the safety and efficacy of the SSRIs in adults. The Guardian understands that it has found a similar picture and that the drug regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA) is likely to impose restrictions on the use of some of them.

The decision will lead to further confusion and uncertainty among doctors treating depression. Child psychiatrists and GPs have shown conflicting reactions to the SSRI ban – some of them continuing to use the drugs, while others hold off. Guidelines from the National Institute for Clinical Excellence (Nice) on treating depression in adults were due to be published this month, but have been postponed pending the MHRA announcement. Guidelines on treating children are not due until next year.

“With our colleagues it is very difficult,” said Sue Bailey, chair of the child and adolescent faculty of the Royal College of Psychiatrists. “They don’t know whether they can or can’t, should or shouldn’t prescribe.”

Two to 6% of children suffer from depression, and suicide is the third leading cause of death in 10-to-19-year-olds, says Professor Bailey. An estimated 40,000 children were on SSRIs last year.

The college has asked the expert group to give “plain English” advice as to what doctors should do, but they have been told they must wait until the MHRA has met to discuss the issues with the European drug regulators. It is well-known that the authorities in some parts of Europe would like the MHRA to tone down the SSRI ban, but Professor Bailey says she finds it hard to see how the MHRA can recant. “It is hard to row back on the data they have shown us,” she said.

A conference on the issues around ensuring medicines are safe for children is taking place today, with contributions from Lord Warner, the health minister responsible, and Sir Alasdair Breckenridge, chair of the MHRA.

Yet the biggest problem in children’s medication today, the SSRIs, is not on the agenda. In a presentation next month, Prof Bailey will call for government and other involved bodies to ensure children have “the same rights to rigorously conducted research programmes” as adults. She points out that the studies of depressed children so far involve some as young as three, in whom depression has to be very carefully diagnosed, using specially trained researchers.

One SSRI has not been banned for use in children – Prozac, which has a licence to treat children’s depression in the United States. Yesterday the manufacturer, Eli Lilly, told the Guardian it had been asked by the MHRA to apply for a licence to treat children with depression in the UK and Europe.

Richard Brook, chief executive of the mental health charity Mind, who resigned from the expert group on SSRIs because of what he claimed was a lack of openness and transparency, said he was appalled that the MHRA which polices the drug companies should approach one of them to suggest it applies for a licence.

“This raises real issues about their impartiality,” he said. “They are saying they want an SSRI to be given to children. It is not their job to decide such a thing. If they are going to do deals with the drug companies, where does it stop? This is a fundamental breach that the minister must investigate.”

Vera Sharaz, from the Alliance for Human Research Protection in the United States, says it is astonishing that Prozac ever got a licence there for use in children, adding that documents from the Food and Drug Administration (FDA) which licensed it show that the first of two studies done, in 1997, failed to reach the target Eli Lilly had set for benefiting children and the second, in 2002, produced serious side-effects, including growth retardation and heart problems.

“Given the concern about evidence of a suicide link to Prozac and the other antidepressants, it is an affront to the public that the MHRA would even consider approving Prozac for children,” she said. Eli Lilly in fact changed the label on the drug in the UK last December to state: not recommended for children.


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