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Friday, 29 January 2010 15:53 GMT
Afssaps says 90% of H1N1 vaccine side effects notified directly to pharmacovigilance centres
PARIS, Jan 29 (APM) - The French health products safety agency, Afssaps, said 90% of all side effect declarations from the H1N1 vaccination programme were notified directly to pharmacovigilance, with only a few cases being notified directly to the pharma companies involved.
Further, Afssaps assistant director general, Fabienne Bartoli said 25% of the H1N1 vaccine side effect notifications in France were notified directly by patients.
Speaking at a health ministry press conference on Thursday, she said it was the first time that patients had been able to declare any side effect directly in France. Previously, this was done via health professionals.
The assistant director general said this change follows on from a trial run Afssaps carried out with some patient associations in 2007.
For GlaxoSmithKline's Alli, (orlistat dosed at 60 mg), 63% of the observations in the pharmacovigilance report issued at the end of September 2009 were reported by the patients directly.
On Thursday, Afssaps issued its 13th H1N1 vaccine pharmacovigilance bulletin, covering GlaxoSmithKline's Pandemrix, Sanofi Pasteur's Panenza, Baxter's Celvapan and Novartis' Focetria. The bulletin does not bring the risk/benefit balance of the products into question.
The bulletin reports three new cases of Guillain-Barré syndrome that occurred following vaccination with Pandemrix (1 case), and with Panenza (2 cases).
The Pandemrix case was observed 29 days after the injection in a 38-year-old man who had presented with viral rhinitis 15 days before the first neurological signs appeared, and who had been vaccinated against diphtheria, tetanus, whooping-cough and polio the day before the H1N1 vaccination.
The two Panenza cases occurred in a man aged 71- 20 days after vaccination and 10 days after acute nasopharyngitis - and in a man aged 86, 11 days after vaccination.
These three cases must be added to the Pandemrix-related case already reported at the early stage of the vaccination campaign; in yet another case, it had not been possible to confirm the diagnosis of Guillain-Barré syndrome.
In two out of the four cases, it is possible that the syndrome was due to H1N1 vaccination but the probability is low, and for the two others, investigations are continuing, Bartoli said.
The four cases are to be compared with over 16 to be expected (on a statistical basis) following the administration of 5.6 million doses of H1N1 vaccine in France.
The bulletin says the data currently do not justify the suspicion of an association between H1N1 vaccination and Guillain-Barré syndrome.
Bartoli also mentioned preliminary data from the body that collates data on Guillain-Barré syndrome, which shows that there were fewer cases at the end of 2009 compared to the end of 2008, probably owing to a delayed and less extensive (than usual) gastroenteritis epidemic.
The head of the French health directorate (DGS), Didier Houssin, said he hoped lessons would be drawn from the pharmacovigilance data, showing that H1N1 vaccination is not responsible for Guillain-Barré syndrome, contrary to "fears" at the start of the campaign that "tarnished" the image of the vaccines.
TWO CASES OF LEUKAEMIA RELAPSE
The Afssaps pharmacovigilance bulletin also presents other adverse events for which the data available so far have not made it possible to make an association with H1N1 vaccine.
Two children, aged 7 and 8, suffered a leukaemia relapse after receiving Pandemrix and Panenza respectively.
There has also been an episode of psoriasis (that has since responded to treatment) following vaccination with Panenza in a 37-year-old female patient who has presented three to four episodes of psoriasis per year for the last few years.
In addition, there was one case of muscle pain (with increased muscle enzymes, but has since responded to treatment) that occurred 15 days after vaccination with Pandemrix in a 61-year-old female patient with no previous history of any such disorder. It has not been possible to exclude the fact that other drugs she took at the time may have been responsible.
There was another case of convulsions together with encephalopathy of undetermined origin following vaccination with Panenza in a 35-year-old female patient who has a serious genetic disease.
Finally, Panenza may have triggered idiopathic thrombocytopenic purpura in a child aged 9, 16 days after vaccination. The child has responded satisfactorily to treatment.
Serious adverse events only account for 4% of the side effects declared.
On Wednesday, the European Medicines Agency (EMEA) published its pharmacovigilance reports on H1N1 vaccine and antivirals and the reports do not question the products' risk/benefit balance.
vdb/aki/ra
[17944] 29/01/2010 15:53 GMT - INDUSTRY
Further, Afssaps assistant director general, Fabienne Bartoli said 25% of the H1N1 vaccine side effect notifications in France were notified directly by patients.
Speaking at a health ministry press conference on Thursday, she said it was the first time that patients had been able to declare any side effect directly in France. Previously, this was done via health professionals.
The assistant director general said this change follows on from a trial run Afssaps carried out with some patient associations in 2007.
For GlaxoSmithKline's Alli, (orlistat dosed at 60 mg), 63% of the observations in the pharmacovigilance report issued at the end of September 2009 were reported by the patients directly.
On Thursday, Afssaps issued its 13th H1N1 vaccine pharmacovigilance bulletin, covering GlaxoSmithKline's Pandemrix, Sanofi Pasteur's Panenza, Baxter's Celvapan and Novartis' Focetria. The bulletin does not bring the risk/benefit balance of the products into question.
The bulletin reports three new cases of Guillain-Barré syndrome that occurred following vaccination with Pandemrix (1 case), and with Panenza (2 cases).
The Pandemrix case was observed 29 days after the injection in a 38-year-old man who had presented with viral rhinitis 15 days before the first neurological signs appeared, and who had been vaccinated against diphtheria, tetanus, whooping-cough and polio the day before the H1N1 vaccination.
The two Panenza cases occurred in a man aged 71- 20 days after vaccination and 10 days after acute nasopharyngitis - and in a man aged 86, 11 days after vaccination.
These three cases must be added to the Pandemrix-related case already reported at the early stage of the vaccination campaign; in yet another case, it had not been possible to confirm the diagnosis of Guillain-Barré syndrome.
In two out of the four cases, it is possible that the syndrome was due to H1N1 vaccination but the probability is low, and for the two others, investigations are continuing, Bartoli said.
The four cases are to be compared with over 16 to be expected (on a statistical basis) following the administration of 5.6 million doses of H1N1 vaccine in France.
The bulletin says the data currently do not justify the suspicion of an association between H1N1 vaccination and Guillain-Barré syndrome.
Bartoli also mentioned preliminary data from the body that collates data on Guillain-Barré syndrome, which shows that there were fewer cases at the end of 2009 compared to the end of 2008, probably owing to a delayed and less extensive (than usual) gastroenteritis epidemic.
The head of the French health directorate (DGS), Didier Houssin, said he hoped lessons would be drawn from the pharmacovigilance data, showing that H1N1 vaccination is not responsible for Guillain-Barré syndrome, contrary to "fears" at the start of the campaign that "tarnished" the image of the vaccines.
TWO CASES OF LEUKAEMIA RELAPSE
The Afssaps pharmacovigilance bulletin also presents other adverse events for which the data available so far have not made it possible to make an association with H1N1 vaccine.
Two children, aged 7 and 8, suffered a leukaemia relapse after receiving Pandemrix and Panenza respectively.
There has also been an episode of psoriasis (that has since responded to treatment) following vaccination with Panenza in a 37-year-old female patient who has presented three to four episodes of psoriasis per year for the last few years.
In addition, there was one case of muscle pain (with increased muscle enzymes, but has since responded to treatment) that occurred 15 days after vaccination with Pandemrix in a 61-year-old female patient with no previous history of any such disorder. It has not been possible to exclude the fact that other drugs she took at the time may have been responsible.
There was another case of convulsions together with encephalopathy of undetermined origin following vaccination with Panenza in a 35-year-old female patient who has a serious genetic disease.
Finally, Panenza may have triggered idiopathic thrombocytopenic purpura in a child aged 9, 16 days after vaccination. The child has responded satisfactorily to treatment.
Serious adverse events only account for 4% of the side effects declared.
On Wednesday, the European Medicines Agency (EMEA) published its pharmacovigilance reports on H1N1 vaccine and antivirals and the reports do not question the products' risk/benefit balance.
vdb/aki/ra
[17944] 29/01/2010 15:53 GMT - INDUSTRY
