FDA Panel Recommends Warnings Added to Flu Drugs
Health advisers in the US recommended on the 27th November that clear warnings are added to the labelling provided with the anti-viral drugs Tamiflu and Relenza.
As previewed in a previous Pharmaceutical International News Item, the pair of flu drugs were scrutinised by a US Food and Drug Administration panel, which examined evidence linking the Roche and GlaxoSmithKline products to cases of irregular psychiatric behaviour. Many of these instances have taken place in Japan, where patients taking either Relenza or Tamiflu have experienced delirium or hallucinations. Where Tamiflu was concerned, a number of these ultimately had tragic results.
Panel Recommended Label Update for Flu Drugs Tamiflu, Relenza
While a definitive connection with the two flu drugs has not been made, the US FDA panel recommended their labels be updated so as to include up to date case reports. The US FDA is not obliged to follow the advice given by the panel, but a number of cases highlight its historical tendency to do so.
According to Dr. Michael Fant, a member of the panel - "The public expects to be made aware. I never hear on the public side, that they are getting too much information. If we're still wrestling with it, to me even though we don't have anything definitive, that in and of itself warrants conveying those concerns to the public."
Japanese Reports Described Bizarre Behaviour in Young Tamiflu Patients
Earlier this year, a number of accounts took place in Japan of Tamiflu having been the source of bizarre behaviour in predominantly young people. The situation prompted the issue of a warning in respect of the prescription of the drug to patients between the age of 10 and 19 years.
Employees at the US FDA have proposed that the patient death factor is worked into Tamiflu's labelling. In respect of Relenza, they recommend the addition of a statement concerning the potential for delirium and hallucinations to take place.
A number of the panel members highlighted the need to observe how, in some instances, irregular activity took place in patients with the flu who were not taking Relenza or Tamiflu - indicating a possible association with the flu itself.
Staff at the US FDA detailed evidence of approximately 700 instances where negative side effects had been generated by the anti-viral drugs.
25 Deaths from Tamiflu, None from Relenza
While no cases of death were connected to Relenza, the staff described 25 involving Tamiflu patients. Three of these happened in the US.
Officials from both GlaxoSmithKline and Roche contested the recommended label amendment measure at yesterday's meeting. According to Roche's Dr Jonathan Solsky, "(it is) very difficult to differentiate drug from disease."
48 Million People Have Used Tamiflu, 4 Million, Relenza
Tamiflu gained approval nine years ago. In the intervening period, it has been taken by approximately 48 million people around the world. Relenza was also launched in the same year, and has been taken by around four million people.
Flu Kills 36,000 in US Each Year
Flu itself - directly or indirectly - claims the lives of around 36,000 people in the US annually, according to an expert from the US government also at the meeting. He added that the youngest and oldest members of society were particularly at risk.
In the words of one of the panel's members, Tamiflu's benefits were minimal when viewed alongside the drug's risk factor. "When we give Tamiflu to children who have influenza, we shorten (the duration of flu) by one day, a day and a half," Dr. Keith Kocis asserted, adding: "To me (the drug's benefit is) relatively minor".
Source - Pharmaceutical International's US Correspondent
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