UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects

The UK National Health Service has taken a decisive, responsible step to protect the lives of children who are being exposed to serious risks of harm from psychotropic drugs. The UK National Institute for Clinical Excellence (Nice) formulated new guidelines that told UK doctors to stop prescribing antidepressants for children under 18, because of the serious risks that the pills will make them feel suicidal.

The Guardian reports:  “The new NHS guidance marks a watershed in the treatment of children’s mental health. It shifts the focus sharply away from the psychiatric drugs that around 40,000 children are thought to be taking for depression, anxiety and other problems. Children with mild depression should be given advice on diet and exercise, the guidance tells GPs. Those with moderate and even severe depression should be offered a three-month course of counselling.”

The new NICE guidelines tell doctors (GPs) to advise children with mild to moderate depression on ways they can help themselves through exercise and diet:

1. Children or young people with moderate to severe depression should not be given anti-depressants except in conjunction with psychological therapy.
2. Healthcare professionals need further training to spot symptoms of depression.
3. An acknowledgement that a parent whose child suffers from a mental disorder may also be suffering some form of depression.
4. Advice on nutrition, exercise and sleep to help combat depression should be more readily available.

Tim Kendall, joint director of the National Collaborating Centre for Mental Health, who was one of the authors of a seminal study published in the Lancet (April 2004) and also led the formulation of the NICE guidelines, said they were even more clear now about the risks.

“No child, however severe the depression, should have their first line treatment with a drug,” he said. “But then if there is any significant risk, we should be offering individual cognitive behaviour therapy or family therapy, depending on their needs. We’re really serious that we don’t think these drugs should be used lightly.”

By contrast, in the US more than 11 million SSRI antidepression drug prescriptions are written annually for under 18 year olds–in complete disregard for their safety. Whereas UK government agencies have taken unified action after careful consideration of the evidence, the FDA and the National Institute of Mental Health have shown a disinclination to interfere with the business of selling drugs. The FDA has both dragged its regulatory feet and has even backtracked on its warnings about drug-linked suicide.

At the end of the September 14, 2004 joint meeting of the FDA Advisory Psychopharmacology Committee and the Pediatric Committee, FDA’s Director of Medical Policy, Dr. Robert Temple, acknowledged: “we could say that causality for this risk has been established in pediatric patients.”

See, DHHS FDA CDER. Joint Meeting of CDER Psychopharmacology Advisory Committee and Pediatric Committee, September 14, 2004 at p. 25: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4065T2.htm

On Oct 15, 2004, the FDA posted its letter specifying the SSRI label change that included the statement: “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.”

See: http://www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm

However, this statement of causality was subsequently deleted without explanation or a scientific justification.

Adding insult to injury, the FDA has submitted an amicus curiae brief (Sept. 15) to a Utah judge asserting (in effect) that FDA’s failure to warn is infallible. FDA’s brief argued that FDA’s failure to require Pfizer to warn doctors about a suicide risk associated with its drug, Zoloft, cannot be challenged by anyone.

The case involves suicide by a 15 year old child (Shyra Kallas) child who was prescribed Zoloft when she complained about warts. [See:https://ahrp.org/infomail/05/08/29.php]

In its brief, the FDA claims that its non-action pre-empts state safety requirements—-even when the evidence-preventable deaths–supports the need for a warning. FDA’s assertion–which implies its infallibility–is truely preposterous given the agency’s culpability in failing to require warnings on the Vioxx label–even as Merck withdrew the deadly drug. If FDA’s pre-emption argument is sustained, it would overturn the checks and balances that are the foundation of democratic rule.  [See AHRP website]

What is the justification for exposing American children to serious risks of harm from drugs that have failed to demonstrate a benefit whereas those risks are deemed intolerable for children in the UK?

Yesterday, GlaxoSmithKline has issued a “Dear Doctor” letter in the US, warning of yet another serious risks posed by Paxil CR: the drug is linked to a 2.2 increased rate of “major congenital malformations in infants born to women taking antidepressants durng the first trimester of pregnancy.”

Psychiatrists and drug manufacturers had misled pregnant women with false reassurances that antidepressants were perfectly safe for their developing fetus, and warned them that “untreated” (i.e., unmedicated) depression was harmful for their baby. Those reassurances were patently false—as withdrawal syndrome in neonates had been documented since the early 1990s.

Widely prescribed drugs have been shown to pose serious risks of harm but those risks often remain hidden for years because FDA’s drug review and approval process is structured NOT to detect serious, but uncommon risks—because disclosure of serious risks of adverse effects would harm a drug’s marketing prospects. Furthermore, no one monitors adverse drug effects of approved drugs despite the existence of an adverse drug effect reporting system that was mandated by Congress. The FDA does not monitor MedWatch reports, thus it is not surprising that only 1% to 10% of adverse drug effects are reported.

Contact: Vera Hassner Sharav
212-595-8974

http://www.guardian.co.uk/uk_news/story/0,3604,1579775,00.html

The Guardian
GPs to stop prescribing antidepressants blamed for suicidal feelings in under-18s
Pills to be phased out for up to 40,000 children New treatments to include exercise and counselling
Sarah Boseley, health editor
Wednesday September 28, 2005

Doctors were yesterday told to stop giving antidepressants to children and people under 18, because of the risks that the pills will make them feel suicidal.

The new NHS guidance marks a watershed in the treatment of children’s mental health. It shifts the focus sharply away from the psychiatric drugs that around 40,000 children are thought to be taking for depression, anxiety and other problems. Children with mild depression should be given advice on diet and exercise, the guidance tells GPs. Those with moderate and even severe depression should be offered a three-month course of counselling.

The guidance is likely to cause consternation among GPs who do not have enough counsellors and therapists available to treat all the children who will need help. “The very significant shortage of practitioners able to deliver these therapies is a cause for concern,” said Dinah Morley, the deputy director of the charity Young Minds, which applauds the new emphasis on therapy.

The government’s National Institute for Clinical Excellence (Nice), which has produced the guidance, says only one drug – Prozac – may help children, and even that carries risks. Only if the “talking therapies” do not work can children be prescribed antidepressants – and even then, only in combination with other forms of counselling and close monitoring for side- effects.

Until recently, most under-18s diagnosed with depression have been treated by their GP and most will have been given a prescription. But in response to growing concern at the potential of the modern antidepressants to make young people feel suicidal – highlighted over several years by the Guardian – Nice has said pills should never again be the treatment of first resort.

In June 2003 the drug licensing body in the UK warned doctors of the risks in prescribing any of the modern antidepressants known as the SSRIs (selective serotonin reuptake inhibitors) for anybody under 18, with the exception of Prozac. All of them had a tendency to increase suicidal thinking, but only Prozac showed any benefit in children to counterbalance the dangerous side-effects.

A study in the Lancet in April last year, which looked not only at trial results the drug companies had published but also those they had not, confirmed the risks to children.

From the mid-90s until two years ago, more and more children who were diagnosed with depression were given tablets by their doctors. The SSRIs were much better tolerated than older antidepressants and were thought very safe for GPs to prescribe. The annual number of prescriptions to those under 18 soared from 13,227 in 1995 up to 27,658 in 2003.

But then the few clinical trials carried out in children had shown that the drugs had serious risks. Some children felt suicidal. That was the case with adults too, but significant numbers of adults appeared to recover from their depression. In children, there was not significant evidence, except for Prozac, that the SSRIs had any benefit to set against the risk. This only came to light because GlaxoSmithKline, British manufacturer of the bestselling SSRI, Seroxat, applied for a licence for the drug to be used in depressed children. It submitted the trial evidence it had to the Medicines and Healthcare Regulatory Authority (MHRA), which regulates drugs.

The data showed that 3.4% of children experienced mood changes, tried to harm themselves or thought of suicide, compared with 1.2% who took a dummy pill in the trials. At the time, there were 8,000 children on Seroxat. In June 2003 the MHRA put out a warning to doctors that they should no longer prescribe it to under-18s. In September they issued a similar warning for a second drug, Efexor. On December 11 the MHRA told doctors all the drugs, except for Prozac, were unsuitable for children, although it left it up to doctors to decide whether or not to continue using them, and many are thought to have done so.

Tim Kendall, joint director of the National Collaborating Centre for Mental Health, who was one of the authors of the Lancet study and also led the formulation of the Nice guidelines, said they were even more clear now about the risks. “No child, however severe the depression, should have their firstline treatment with a drug,” he said.

He and his colleagues are concerned about the numbers of children with depression, which is sometimes triggered by a sad event like a death, but is often linked to poverty, deprivation, abuse and family breakups. “Our view is that we should be targeting these children as best we can,” he said. “Out of 1,200 kids in a comprehensive, at least 40 would be expected to suffer a diagnosis of depressive illness and only 10 are getting any help.”

The new guidance for doctors says GPs should advise children with mild to moderate depression on ways they can help themselves through exercise and diet. “But then if there is any significant risk, we should be offering individual cognitive behaviour therapy or family therapy, depending on their needs,” he said. “We’re really serious that we don’t think these drugs should be used lightly.”

Even when a young person is severely depressed, the first step should be psychotherapy for around three months. Only if there has been no improvement after four or five sessions should the doctor – and by this stage it would be a psychiatrist – consider prescribing Prozac.

Andrew Dillon, chief executive of Nice, said the guideline “makes it clear that psychological treatments are the most effective way to treat depression in children and young people.” Children taking pills should talk to their GP about phasing them out.

At present, there are not enough counsellors and therapists to help all the children who may need it. Yesterday Louis Appleby, the national director for mental health, said: “We know that not everyone who needs treatment is able to access it easily or quickly and expertise and services are not equally distributed around the country.” He added that the government was “considering ways of increasing numbers of staff” trained in cognitive behaviour therapy, which is usually the preferred treatment for depression. More than £300m had gone into child and adolescent mental health services.

Mind, the mental health association, urged the government to give the NHS the support and resources it would need to ensure children have proper access to psychological treatments. Research on antidepressants “has shown many to be totally unsuitable for young people. They must be provided with effective alternatives,” said a policy officer, Alison Cobb.

“These guidelines are a welcome step in the right direction: the onus is now on the government to provide the means to make them happen,” said Liz Nightingale of the mental health charity Rethink.

Danger signs

• In 2003, under-18s in England were given 27, 658 prescriptions for antidepressants
• 40,000 children and young people are thought to be on psychiatric drugs, including antidepressants
• Doctors were warned in 2003 of the risks of using Seroxat, Efexor, Lustral, Cipramil, Cipralex and Faverin in children and young people
• A survey of GPs in March 2004 found 80% thought they were prescribing SSRIs to too many adults and children

http://news.yahoo.com/s/nm/20050927/hl_nm/glaxosmithkline_paxil_dc

Glaxo adds birth defect caution to Paxil label

GlaxoSmithKline Plc is alerting physicians about a study suggesting the company’s antidepressant Paxil may be more likely to be linked to birth defects than similar drugs, U.S. regulators said on Tuesday.

The company, in a letter posted on the Food and Drug Administration Web site, said it was adding the information to the prescribing instructions on Paxil’s label. Glaxo added that it was difficult to tell if Paxil caused the defects, most of which were cardiovascular, in infants born to women who took the drug while pregnant.

“Preliminary results suggest an increase in the risk of congenital malformations associated with the use of (Paxil) as compared to other antidepressants,” the company’s letter to physicians said.

“The preliminary results of this study and recent abstracts … differ from previous epidemiologic studies, making it difficult to conclude whether a causal relationship exists,” it said.

Physicians should “carefully weigh the potential risks and benefits of using paroxetine (Paxil) therapy in women during pregnancy and … discuss these findings as well as treatment alternatives with their patients,” the FDA said.

The letter is available online at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2

Copyright © 2005 Reuters

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