US FDA Panel to Discuss Anti-Viral Drug Warnings
The US Food and Drug Administration has recently focused on a pair of drugs to which psychiatric episodes could be associated. Shortly, a US FDA panel will assess the recommendations made for anti-viral drugs Relenza and Tamiflu - which are made by GlaxoSmithKline and Roche Holdings AG respectively.
In 2005, a meeting was held by the US FDA after it emerged that around 12 Japanese children had died after having taken Tamiflu. At the time, a solid link between the influenza drug and the dozen fatalities could not be established. However, the agency ordered that its labelling be modified to heighten awareness of the need to closely monitor those taking it for signs of self-harm, delirium and other erratic behaviour.
FDA Staff Urge for Anti-Viral Drug Label Change
In paperwork prepared in advance of the imminent panel meeting, staff working at the US FDA urged for Tamiflu's label to be reworked, so as to include the statement: "In some cases, these behaviours (sic) resulted in serious injuries, including death, in adult and pediatric (sic) patients."
In respect of Relenza, a recommendation was given that, if implemented, would see its label updated to highlight "reports of hallucinations, delirium and abnormal behavior" recorded in a number of patients. GSK's anti-viral drug does not, at present, make reference to psychiatric instances on its labelling.
According to the US FDA employees, "conflicting" evidence exists regarding whether the side effects can be directly attributed to the drugs, whether they exacerbate innate conditions in patients, or whether both situations are at work.
Roche's Tamiflu, or 'oseltamavir', is an oral medication, while GSK's Relenza ('zanamivir') is designed to be inhaled.
According to a spokesman from Roche, no proof existed to casually connect Tamiflu with psychiatric instances. "Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies", he said, adding: "Roche takes all adverse events reports very seriously."
Approximately 48 million people, of whom 21 million are children, have taken the drug in the eight years since it was approved, the spokesman emphasised.
A spokesman for GlaxoSmithKline, meanwhile, stated that a study of Relenza trial data had not yielded any areas of concern.
US FDA Staff Studied Patient Data Showing Flu Drugs/ Psychiatric Events Link
The US FDA staff recommendations were based on a study of almost 600 instances where patients taking Tamiflu had experienced psychiatric events. 115 patients reported similar in respect of Relenza.
The meeting between the agency and its panel will occur on the 27th November 2007. While the US FDA is not obliged to follow the advice given by the panel, a number of cases highlight its historical tendency to do so.
Source - Pharmaceutical International's US Correspondent
Recent related News Item:
