Hib booster set for routine use
The Medicines and Healthcare Products Regulatory Agency is reassessing the safety of fluoxetine (Prozac) in children after US regulators claimed the drug had the same risk of causing suicidal feelings as other SSRIs.
The US Food and Drug Administration's admission at a hearing in Washington last week cast doubt on the agency's current advice that the 'balance of benefits and risks of fluoxetine is favourable in treatment of depression in children and adolescents'.
Robert Temple, director of the FDA office of medical policy, told a US panel investigating SSRI safety: 'I think we now all believe there is an increase in suicidal thinking across all the drugs.'
The FDA's position raised concerns the MHRA lacked access to all the relevant data. The MHRA said it would consult the Committee on Safety of Medicines on the new data.