Tamiflu (oseltamivir phosphate)
21st August 2009 WARNING
The World Health Organisation issued a directive that Tamiflu should not be given to people who think they have Swine Flu, if they have no other health problems. There is concern that the virus will become resistant due to the over-prescribing currently taking place.
There is concern about the sickness, insomnia and nightmares children are experiencing due to the adverse side effects of Tamiflu.
The US Food and Drug Administration (FDA) web site contains the following warning from Roche, the manufacturer of Tamiflu.
Patients with influenza should be closely moniotored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evalutated for each patient. Roche Tamiflu Prescribing information Jan 17 2008
http://www.fda.gov/medwatch/safety/2008/Tamiflu_PI.pdf
The following was posted on the FDA web site:
Audience: Pediatric and infectious disease healthcare professionals
[Posted 03/04/2008, UPDATED 03/04/2008]
Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows:
Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data.
These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tamiflu
The UK regulator of medicines the Medicines and Healthcare Products Regulatory Agency (MHRA) were due to issue a similar warning as the FDA have, according to an article in The Guardian newspaper November 2006
http://www.guardian.co.uk/world/2006/nov/20/birdflu.health1
It is however not easy to find such warnings on the MHRA web site. The fact that Roche have taken opportunities to promote Tamiflu direct to the public which is against the UK and EU law, is however mentioned if you put Tamiflu in the search box on the MHRA web site:
http://www.mhra.gov.uk/SearchHelp/Search/Searchresults/index.htm?within=Yes&keywords=Tamiflu
Please submit a Yellow Card report to the regulator (MHRA)
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