Anti flu - Tamiflu

Tamiflu (oseltamivir phosphate)

This drug stockpiled at huge cost to the NHS was shown to be a waste of money

Tamiflu: Millions wasted on flu drug, claims major report 

click above for full report By James Gallagher Health and science reporter, BBC News

The Guardian newspaper recorded clinical trial data was flawed and stated "

"We now know the government's Tamiflu stockpile wouldn't have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there's a lot we don't know about other medicines we take"

Dr Ben Goldacre wrote about  What the Tamiflu saga tells us about drug trials and big pharma

Tamiflu was linked to psychiatric and physical adverse drug reactions (ADRs) - Millie Kieve attended a meeting in the House of Commons with trustee Ramo, we wanted to discuss the psychiatric side effects reported and were told we could not. We later found the meeting about Tamiflu was sponsored by the manufacturer.

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 issued 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"

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.

 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

It was 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, was mentioned if you put Tamiflu in the search box on the MHRA web site: This data is now unavailable in the .Gov archive of MHRA information.

Reporting Adverse Drug Reactions (ADRs)

It is well known that serious side effects of medicines are under reported and the UK regulatory body the Medicines and Healthcare Regulatory Agency (MHRA) estimate less than 10% of serious ADRs are reported.

If you are, for no apparent reason, feeling mentally distressed, it may be caused by starting or stopping medication, due to a changed dose, withdrawal effects, interactions with other drugs, or following surgery. You can request a list of drugs used pre surgery and during surgery and those for pain or infection to be taken later.

Some drugs must not be stopped suddenly

If you have suffered psychiatric, neurological or physical adverse drug reactions (ADRs) please report them. There may be adverse effects not mentioned on the patient leaflets (PILs) or data sheets. (SPCs)

You should be given a patient information leaflet (PIL) for all drugs prescribed, either as you are discharged from hospital, or if the pharmacy supplies you from a bulk supply of pills. (EU Directive 1997)

Please report Adverse Drug Reactions (ADRs) to:

UK - Yellow Card Reporting for Patient and Health Professional reports of Adverse Drug Reactions you can report to the MHRA using the link above or call them 0808 100 3352 10am - 2pm Monday to Friday

USA and worldwide - to the Food and Drug Administration for Patients and Healthcare Professionals

Universal free, independent drug safety website - Rxisk

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