Other safety alerts
|
| |
| The European Union : European Medicines Agency reviewed further data on narcolepsy and possible association with Pandemix – Casual relationship not established and further study results awaited |
| |
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has reported that upon further review of data from Finland with respect to suspected link between narcolepsy in children and adolescents and Pandemrix, the Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.
EMA reports that in addition to the data from Finland, research is ongoing in Sweden where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix. However, other non-Nordic countries have not seen similar increased rates of reporting of narcolepsy. Additionally in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy. Therefore, at present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed.
The EMA will provide updates when new information becomes available.
Detailed Information is available at the following EMA’s website :http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/02/WC500102213.pdf
Situation in Hong Kong : Pandemix is not registered in Hong Kong. Press release regarding Pandemix was issued on 9 February 2011. The news was also posted on Pharmaceutical Service’s website on the same day. |
| |
|
