Pfizer hits out at SSRI ruling
pharmafile | December 15, 2003 | News story | Sales and Marketing |
Pfizer has criticised new UK guidance advising doctors that Prozac is the only SSRI anti-depressant safe to prescribe to children.
The new advice is the latest development in the MHRA's investigation into the benefit/risk profile of the SSRI (Selective Serotonin Reuptake Inhibitor) class, and follows specific guidance earlier this year, first on GSK's Seroxat and then Wyeth's Efexor advising against their use in children to treat major depressive disorder (MDD).
The Committee on Safety of Medicine's expert group investigating the drugs has now expanded that guidance to include Lundbeck's Cipramil (citalopram) and Cipralex (escitalopram), Solvay's Faverin (fluvoxamine) and Pfizer's Lustral (sertraline).
After extensive analysis of data from trials of each of the medicines, the committee found there was no, or insufficient evidence that the benefits of the drugs outweighed the risks of side effects observed, including self-harm and suicidal thoughts.
None of the SSRI class has ever been licenced for use in children to treat MDD but are prescribed 'off-label' by doctors across the UK to 30-40,000 children and teenagers every year.
Around half this total are currently treated with Prozac, a figure certain to rise to nearly 100% as the new guidance is adopted. Unlike other drugs in the class, trial data for Prozac showed no increased rate of self-harm or suicidal thoughts in under-18s. In January this year the drug became the first SSRI to be granted a US licence to treat MDD and obsessive compulsive disorder (OCD) in children over seven.
Pfizer say it disagrees with the MHRA guidance on its product Lustral, claiming 600 patients with MDD or OCD between the ages of six and 17 had received Lustral in clinical trials, with a good safety profile similar to that observed in adult populations.
The company said in a statement: "Pfizer disagrees with this guidance based on a thorough review of our clinical trial database. While Pfizer has not pursued a licence for the treatment of paediatric MDD, Pfizer believes that the robust clinical programme involving sertraline suggests no increased risk of harm to any population, including children and adolescents."
Meanwhile Lustral and Solvay's Faverin are the only two drugs in the class licenced to treat OCD in children. Pfizer said the MHRA had 'recently reaffirmed' the safety of its drug in the treatment of OCD in children which it has been licensed since 1997.
The new MHRA guidance notes that some children being treated for this condition will be on other SSRIs, and that worried parents should discuss their concerns with their child's doctor.
The new guidelines have been published ahead of the expert committee's final rulings on the overall safety of SSRI class, which is due sometime in spring 2004.
Professor Ian Weller, chairman of the group said: "We are now working on completing the review of the safety of these medicines in adults. This is one of the most comprehensive reviews of a class of medicines ever to be undertaken and it ispainstaking work, examining evidence from literally hundreds of clinical trials but we are determined to see this important work through.
"In the meantime, there is no evidence to suggest that the risks of treatment outweigh the benefits in adults. Patients who are experiencing any side effects or are concerned about their treatment should discuss these with their doctor," he concluded.
The investigation has been dogged by controversy: in March this year the first investigation into the drugs was aborted after members of the expert committee were found to have undeclared links to pharmaceutical companies. In May a new committee was appointed, and included patient representatives for the first time.
In response to continuing criticism about its lack of transparency, the MHRA is making available for the first time clinical trial data from all the drugs concerned, with the blessing of the drug companies who made it available to the expert committee.
The MHRA also defended the time taken to issue the guidance, but mental health charity Mind said the large-scale off-label prescribing to children of a drug now proven to be harmful was "totally unacceptable."
Mind chief executive and a member of the inquiry team Richard Brook said: "The loud voices of users and a high profile campaign started a course of events that led to today's announcement. Long-term, effective and strong regulation has not been evident in this case or provided the type of information consumers have the right to expect.
"Mind believes that if consumers are to have any confidence in this programme the government must instigate a full and independent review [of the MHRA 's operations] with significant consumer involvement of this flawed regulatory process without delay.
He concluded: "There are enormous commercial interests trying to influence decisions about the use of drugs. Pharmaceutical companies represent the second largest industry in the UK. The public needs to have confidence that their health is being properly protected – particularly where children are concerned – and I do not believe we have a process in place at present that ensures this is happening."
Meanwhile Marjorie Wallace, chief executive of SANE, another mental health charity expressed doubts about the new guidance: "We acknowledge that some of the new anti-depressants can have disturbing side effects in children and adolescents. However, because of the huge lack of psychologists and others able to provide alternative help, withdrawing these drugs will leave many families struggling without the chance of treatment and left, often in desperation, to cope as best they can."
A Europe-wide assessment of the benefit/safety profile of GlaxoSmithKline's Seroxat in all patients was announced by the EMEA in July following a request from the MHRA.
External links
MHRA guidance on SSRIs in children and adolescents
