Black box warning for antidepressants in US
pharmafile | November 2, 2004 | News story | |
The industry's biggest selling antidepressants will all have to carry the strongest possible warnings in the US, after the FDA decided the drugs were linked to increased risk of suicidal thoughts and behaviour in children and adolescents.
The 'black box' warning will emphasise the need for close monitoring of patients when first prescribed an antidepressant, with advice to their families to observe them and report any unusual behavioural changes to their doctor.
The FDA has also decided that pharmacists should give patients guides with each new or repeat prescription advising them of the risks and precautions to be taken with the drugs.
Acting FDA Commissioner Dr Lester Crawford said: "Our conclusions are based on the latest and best science. They reflect what we have heard from our advisory committee, as well as what many members of the public have told us."
Black box warnings have been used in just ten drugs prior to the new instructions, but the concerns over antidepressant use in under-18s is unprecedented, sparking an inquiry by Congress and sustained media coverage.
Of the newer drugs, only fluoxetine (Lilly's Prozac) is licensed in children but the move has nevertheless been criticised by the American Psychiatric Association which says the warning could deter doctors from prescribing which it says can be extremely helpful in treating depression in the age groups.
The warning applies to a number of different drugs, including older tricyclics, typical antidepressants such as GlaxoSmithKline's Wellbutrin and Wyeth's Efexor XR and selective serotonin reuptake inhibitors (SSRIs) like Pfizer's Zoloft.
Zoloft (known as Lustral in the UK) is the most commonly prescribed SSRI in the US, and manufacturers Pfizer have welcomed the new labelling, adding: "[We] remain confident in the proven safety and efficacy of Zoloft to treat millions of patients with mood and anxiety disorders. We expect Zoloft to continue performing strongly in our portfolio."
The FDA's decision was based on an analysis of nine placebo-controlled, short-term clinical trials of antidepressants in children and adolescents with major depressive disorder, obsessive compulsive disorder, or other psychiatric disorders.
Analysis of trial results from a number of drugs showed that although no suicides occurred, those taking an antidepressant had twice the risk of suicidality during the first few months of treatment.
The agency said its labelling changes had to apply to all antidepressants including Lilly's newly approved Cymbalta because it did not have adequate data to rule out any of the treatments from having the increased suicidality risk.
Related articles:
US antidepressant prescribing falls in under-18s
Thursday , September 23, 2004
