Paxil: Submission of a written counterargument against the GSK’s reply on the risk of the Paxil for pregnant women.
2010-04-09
We sent an opinion letter on Paxil to GSK dated April 9.
This is counterargument against the written reply from GSK to our written request entitled "Revision of the Package Insert and Need of Patient Information Leaflets on Antidepressant Paxil Tablets for Pregnant Women" dated October 21 last year.
The outline of our written request is the following:
http://www.yakugai.gr.jp/en/topics/topic.php?id=661
However, GSK don’t accept the need to revise the warnings section of package insert of Paxil. And there is no answer to our request that GSK should provide Patient Information Leaflets at medical practice in order to call sufficient attention to the risks in newborns.
It is difficult to find that GSK has the kind of a positive attitude to provide sufficient information on the risk of the Paxil to every doctor and every patient.
After having issued our written request, there was a lot of response to it.
It suggests that more attention should be provided to patients.
Therefore, we sent the written counterargument and pointed out the problems of GSK's reply
- Related Documents And URL
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- a written counterargument against the GSK’s reply on the risk of the Paxil for pregnant women（Japanese）（17 KB）
- a written reply from GSK（Japanese)（148 KB）
- Submission of a written request entitled “Revision of the Package Insert and Need of Patient Information Leaflets on Antidepressant Paxil Tablets for Pregnant Women.”(English)
